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The "Walking Forward" program is a scientific collaborative program between Rapid City Regional Hospital, the University of Wisconsin, the Mayo Clinic, and partnerships with the American Indian community in western South Dakota-3 reservations and 1 urban population. The purpose is to increase participation of health disparities populations on National Cancer Institute clinical trials as part of the Cancer Disparities Research Partnership program. Clinical practice suggests that Native American cancer patients present with more advanced stages of cancer and hence have lower cure rates and higher treatment-related morbidities. It is hypothesized that a conventional course of cancer treatment lasting 6 to 8 weeks may be a barrier. Innovative clinical trials have been developed to shorten the course of treatment. A molecular predisposition to treatment side effects is also explored. These clinical endeavors will be performed in conjunction with a patient navigator research program. Research metrics include analysis of process, clinical trials participation, treatment outcome, and assessment of access to cancer care at an early stage of disease.
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Walking Forward:
The South Dakota Native American Project
AbstractBackground. The “Walking Forward” program is a scientific collaborative program be
tween Rapid City Regional Hospital, the University of Wisconsin, the Mayo Clinic, and partner
ships with the American Indian community in western South Dakota—3 reservations and 1 urban
population. The purpose is to increase participation of health disparities populations on National
Cancer Institute clinical trials as part of the Cancer Disparities Research Partnership program. Clin
ical practice suggests that Native American cancer patients present with more advanced stages of
cancer and hence have lower cure rates and higher treatment-related morbidities. It is hypothesized
that a conventional course of cancer treatment lasting 6 to 8 weeks may be a barrier. Methods.
Therefore, innovative clinical trials have been developed to shorten the course of treatment. A mo
lecular predisposition to treatment side effects is also explored. Results and Conclusions. All of these
clinical endeavors will be performed in conjunction with a patient navigator program. Research
metrics include analysis of process, clinical trials participation, treatment outcome, and access to
cancer care at an early stage of disease. J Cancer Educ. 2005; 20:65-70.
hat there are differential trends in cancer detection,
treatment, clinical trials participation, and treat-
ment outcomes between various US subpopulations
has long been recognized.
The National Cancer Institute
(NCI) has recently initiated a unique research program to
evaluate and potentially redress this situation through com-
munity-based hospitals partnering with comprehensive can
cer centers to target underserved populations. We describe
the basic structure of this important program, “Walking For
ward,” which focuses on the Native American population in
the region surrounding Rapid City, SD.
The burden of cancer is not borne equally by all popula-
tion groups in the United States. The unequal burden is ex-
emplified by differences in cancer morbidity and mortality as
a function of gender, ethnicity, and socioeconomic status.
Colorectal cancers among Alaska Native men and kidney
cancer among southwestern American Indian men are high
er than those for any other racial or ethnic group.
In addi
tion to significant differences in morbidity and mortality,
there are variables in treatment and patient comorbidities
that influence outcome.
Barriers to Quality Cancer Care
There are numerous well-documented barriers that may
influence the type of cancer care a patient receives: (1) lack
of knowledge about state-of-the-art cancer care; (2) fear and
distrust of the health care system; (3) lack of access to cancer
care (not referred or unable to access due to finances, lack of
child care, etc); (4) geographic isolation (travel distances);
(5) socioeconomic factors such as age, education, income,
family status, and lack of insurance; (6) gender and race
(sexism and racism); (7) fear of diagnostic tests, treatment,
and side effects (disfigurement, pain, nausea, etc); and (8)
differing cultural views of health and disease processes.
These barriers and/or factors include structural factors
that influence physician recommendations and patient deci
Received from John T. Vucurevich Cancer Care Institute, Rapid City,
South Dakota (DGP, DR); Department of Human Oncology, University of
Wisconsin Comprehensive Cancer Center, Madison, Wisconsin (DGP,
SPH, JFFMPM); Native American Cancer Research Corporation Pine,
Colorado (LP); Mayo Clinic Comprehensive Cancer Center, Rochester,
Minnesota (JK); Radiation Research Program, National Cancer Institute
(FG, CNC); SAIC-Frederick, Inc., A Subsidiary of Science Applications
International Corporation (CHO); Department of Biostatistics and Medi
cal Informatics, University of Wisconsin Comprehensive Cancer Center,
Madison, Wisconsin (RC).
Supported by National Institutes of Health Grant RFA
1U56CA99010-01. This project has been funded in part with Federal funds
from the National Cancer Institute, National Institutes of Health under
contract no. N01-CO-12400.
Address correspondence and reprint requests to: Daniel G. Petereit,
MD; John T. Vucurevich Cancer Care Institute, 353 Fairmont Boulevard,
Rapid City, SD 57701; phone: (605) 719-2360; fax: (XXX) XXX-XXXX;
e-mail: <>.
sion making.
Estimates suggest that access to care accounts
for about 10% of the variability in health status of popula
tions, health behaviors account for 50% of the discrepancy,
the environment another 20%, and genetics 20%.
behaviors and health status are further influenced by cul
tural norms and patterns of interaction with family, the com
munity, and health care systems.
Those barriers affect eth
nic minority participation in clinical trials and access to
experts and high-technology care. In particular, cancer
treatment trials, prevention trials, and surveillance programs
suffer from a disproportionately low rate of accrual and a
high rate of dropouts of ethnic minorities. Therefore, ethnic
and minority populations do not adequately access or benefit
from the rapid progress being made in cancer research. In ad
dition, data confirm lower rates of cancer screening and early
detection, differential treatment patterns, and greater fre
quency of a number of chronic diseases with similar risk pro
files to cancer.
These and many other factors contribute to
more advanced disease at diagnosis, lower survival, and
higher cancer death rates among certain United States pop
ulation groups.
The NCI Initiative
Community and rural hospitals that provide radiation
oncology services to a large number of medically under-
served, low-income, ethnic or minority populations struggle
to maintain state-of-the-art cancer care. The increased in
volvement of these institutions is necessary to develop a
stronger national cancer research effort aimed at addressing
cancer health disparities. The populations served by these
community institutions tend to access the health care sys
tem in the advanced stages of their disease, so radiation on
cology represents a major treatment modality. Therefore, the
field of radiation oncology offers a unique opportunity to ex
plore ways to reduce cancer related health disparities. The
Cooperative Planning Grant for Cancer Disparities Re
search Partnership Program (CDRP) was created by the NCI
in an effort to develop stable, long-term radiation oncology
clinical research programs with the participation of institu
tions that serve a disproportionate number of minority pa
tients. The overall goal of the CDRP program is to develop
effective interventions to reduce and eventually eliminate
these disparities.
Rapid City Regional Hospital and Its Service Population
Rapid City Regional Hospital (RCRH) is the sole health
care provider located in a town of 70,000. It serves all of
western South Dakota and parts of adjacent states (espe
cially Wyoming and Nebraska) including 4 large Indian res
ervations in western South Dakota and other smaller Native
American communities in the region. Its “service basin” in-
corporates a geographic area of 250,000 square miles with a
population base of 350,000 (Figure 1). The Native Ameri-
66 PETEREIT et al.
Clinical Disparities in Native Americans
can population within the RCRH service area, estimated at
60,000, utilizes this facility for secondary and tertiary health
There is not a history of academic or clinical research at
RCRH (other than participation in cooperative group tri
als). Consequently, the partner institution concept inherent
in this NCI project is critical to bring the necessary expertise
in protocol and survey development and implementation,
database compilation and analysis, human subjects protec
tion, grants administration, and public outreach regarding
the safety and desirability of the clinical trials process. The 2
partner institutions, the University of Wisconsin Compre
hensive Cancer Center and the Mayo Rochester Compre
hensive Cancer Center (Mayo), are NCI-designated com
prehensive cancer centers.
Although there is a good understanding of cancer barriers
nationwide, there is no hard documentation of barriers af
fecting the Native American population within the RCRH
service area. Geographic dislocation from the community
may represent an impediment to seeking earlier treatment,
as Native Americans live a median of 110 miles from the
cancer center in Rapid City, with a range of 5 to 215 miles
(Figure 1). Tumor registry data from RCRH show Native
Americans appear to present with more advanced stages of
cancer and suffer from higher cancer mortality rates com-
pared to the non-Native American population (Table 1).
Radiation Modalities to Treat Cancer
Radiation is utilized as either primary or adjuvant treat-
ment for a significant percentage of cancers. Radiation is de-
livered as either external beam radiotherapy or brachyther-
apy. External beam radiation is given from the outside and is
therefore noninvasive, whereas brachytherapy is an invasive
procedure where radioactive elements are placed inside of
the tumor. Brachytherapy can either be given slowly—called
low-dose-rate (LDR) brachytherapy and requires hospital
ization—or quickly with a system called high-dose-rate
(HDR) brachytherapy since the radioactive source is in the
tumor for a period of minutes. The advantages of HDR
brachytherapy include elimination of radiation exposure to
staff, very precise treatment delivery, and possible outpatient
therapy. Brachytherapy is commonly used to treat lung,
breast, gynecological, and prostate cancers. The primary
advantage of brachytherapy is that it delivers a much higher
radiation dose to the tumor while sparing the adjacent nor
mal tissues. This often translates into improved survival
and/or decreased morbidity since higher doses are more safe
ly administered compared to external beam radiotherapy.
Prostate Cancer
Whereas the majority of prostate cancer patients in the
United States are detected with organ-confined disease, this
has not been our experience for patients in western South Da
kota—both Native American and non-Native American
(Table 1). Effective radiation options for these patients in
clude permanent seed implantation and 3-dimensional con
formal radiotherapy. However, for patients with more ad
vanced stages of disease—but still nonmetastatic—more
intensive radiation doses have translated into improved out
This hasbeen accomplished through brachytherapy,
both LDR and HDR, as well as with external beam radiation.
HDR brachytherapy is being increasingly used as another
method of dose escalation. Some of these advantages include
a potential radiobiologic rationale, markedly lower acute tox
icities and improved dosimetry compared to a permanent seed
boost, and elimination of radiation exposure.
Androgen ablation (hormones) combined with radiation
has also improved several clinical endpoints including sur-
It appears that hormones sensitize prostate cancer to
radiation and may even eliminate microscopic metastatic
foci if given long enough.
Breast Cancer, Breast Brachytherapy
Breast conservation is a standard treatment option for the
majority of patients with early stage breast cancer. The data
supporting this approach comes from at least 6 randomized
trials. Five to 6 weeks of breast radiation is often an impedi
ment to breast conservation.
Patients in western South
Dakota have had some of the highest mastectomy rates in
the nation. A Medicare survey from 1992-1993 reported
that only 1.4% of Medicare patients underwent breast con
servation in Rapid City, SD.
Although the reasons are
multiple, the distance from the cancer center is presumed to
be a major impediment to breast conservation.
To address the issue of treatment prolongation with exter
nal beam radiation, a number of investigators have exam
ined accelerated, partial breast radiotherapy—using either
external beam radiation or brachytherapy. Results of 5 to 8
years from a number of institutions have strongly suggested
that partial breast radiotherapy using brachytherapy pro
duces comparable results to external beam radiation, with
local recurrence rates < 5%.
Radiation Toxicity
Anecdotally, the Native American patient population
appears to be acutely hypersensitive to fractionated radio
therapy. This manifests as more severe skin/mucosal reac
67 PETEREIT et al.
Clinical Disparities in Native Americans
TABLE 1. Stages of Disease at Presentation for Native
Americans and Whites at Rapid City Regional Hospital’s
John T. Vucurevich Cancer Care Institute, Tumor Registry
Data for 1990 Through 2000.
Stage III and IV
Native American
Stage III and IV
Lung 72% (92/127) 68% (669/989)
Breast 16% (12/75) 10% (111/1127)
Colorectal 48% (26/54) 40% (298/739)
Prostate 44% (8/15) 26% (13/51)
Total 50% (160/321) 36% (1372/3851)
tions compared to non-Native populations. In a retrospec
tive analysis of Native Americans treated with curative
intent in Rapid City, 50% experienced acute Grade 2 toxici
ties, and 17% experienced Grade 3 toxicities. Skin toxicities
accounted for the majority of Grade 3 reactions (15% of all
61 patients). This may partially explain why treatment de
lays of 6 days were observed in 28% of patients, and delays of
11 days in 15% of patients.
Prolongation of treatment time
in several tumor sites has been associated with an adverse
One explanation for the purported increased
toxicity is possibly an underlying genetic susceptibility. This
phenomenon has been observed in many conditions, per
haps most dramatically in patients with homozygous muta
tions of the ataxia telangiectasia (AT) gene. AT is an au
tosomal recessive syndrome characterized by progressive
cerebellar ataxia, oculocutaneous telangiectasia, and im
mune deficiency. An established hallmark of this syndrome
is hypersensitivity to ionizing radiation. Swift et al
mated that approximately 1% of the general population is
heterozygous for the AT gene; other estimates suggest that
the incidence may be as high as 5%. Although phenotyp
ically normal and asymptomatic, AT heterozygotes carry an
excess risk for the development of cancer. The incidence of
the AT heterozygote within the Native American popula-
tion remains unknown, but it is known that there are signifi-
cant population differences in the incidence of ataxia telan-
giectasia mutation (ATM) heterozygosity.
Walking Forward Project
The South Dakota Native American initiative at RCRH,
“Enhancing Native American Participation in RT Trials”
(NCI U56CA99010), is called the Walking Forward Pro
ject. The primary long-term goal of the CDRP Program at
RCRH is to lower cancer mortality rates for Native Ameri
cans in the region.
A patient navigator program has been created that relies
on the used of trained community research representatives
(CRRs) to serve as lay health advisors. This aspect of the
program is done in conjunction with the NCI Center to Re
duce Cancer Health Disparities. Specific objectives of the
program are (1) to provide culturally appropriate public edu
cation on cancer prevention, development, diagnosis, treat
ment, and follow-up; (2) to improve access to early diagnosis
and treatment; (3) to provide assistance to patients in “navi
gating” the health care and related insurance system; (4) to
provide patients with resources for emotional and social sup
port; (5) to provide logistical support for patients who must
travel to receive health care; and (6) to increase enrollment
and reduce dropout rates in clinical research trials.
General Population Survey
Native Americans do not appear to access novel cancer
therapies and clinical trials due to barriers—both real and
perceived. One recent survey found that 75% of cancer pa
tients in their sample were not aware of the opportunity to
participate in clinical trials.
Likewise, the National Native
American Cancer Survivors’ Support Network has docu
mented that less than 5% of Native patients were provided
information about potential clinical trials participation. To
examine the potential barriers to accessing the best cancer
a culturally responsive survey has been devel
oped by project staff in partnership with tribal members. A
stratified sampling design will be used to ensure equitable
distribution of respondents across the 3 reservations and the
1 urban area under study. This survey will be administered to
the general population. It is anticipated that 1000 surveys
will be administered. The impact of traditional healing, ie,
medicine men and women, on western medicine will be as
sessed since this is a significant part of the Lakota tradition.
Results from the survey will be used to modify the proposed
education module and other project activities.
Cancer Educational Intervention
An educational module is being developed for breast
and prostate cancer, diseases that have complex treatment
choices and unique cultural connotations within Northern
Plains tribes. The goals of these modules are to provide cul-
turally relevant breast and prostate information to influence
earlier diagnoses of cancer (ie, stages I and II), thus making
the patient potentially eligible for participation in radiation
therapy clinical trials provided by RCRH. We have part-
nered with Native American Cancer Research (NACR) on
this component of the project. NACR has developed and
evaluated a culturally specific and effective “Clinical Trials
Education for Native Americans” curriculum, available on
their Web site.
Based on this curriculum, NACR began de-
veloping an interactive, tailored, quality of life education in
tervention to increase Native patients’ understanding of
clinical trials to increase opportunities for participation in
breast cancer clinical trials. The quality of life clinical trial
module is focused on the radiation therapy clinical trial be
ing provided by RCRH and expands an existing NACR
product, “Get on the Path to Breast Health,” which provides
basic background for the module (available on the NACR
Web page). The first 6 segments of a comparable background
module completed pretesting May 2004, “Get on the Path to
Prostate Health.” These materials will be integrated within
the project’s community education activities. NACR will
provide training on how to use the culturally and geographi
cally specific quality of life interactive, tailored modules for
the RCRH CRRs in 2004.
A primary hypothesis of this project is that Native Amer
icans forego conventional radiation cancer treatments to re
main within their cultural infrastructure. This becomes even
more problematic for patients who live 2 to 3 hours away.
Therefore, a shorter treatment course with culturally compe
68 PETEREIT et al.
Clinical Disparities in Native Americans
tent navigators might be more acceptable, which could lead
to earlier treatment and better survival. To address this
potential barrier, clinical protocols have been developed
utilizing advanced radiation oncology delivery systems, ie,
brachytherapy and tomotherapy, to shorten a course of radi
ation of 6 to 8 weeks to 1 to 4 weeks. All clinical treatment
trials will be offered to the non-Native American population
as well.
HDR Brachytherapy as Monotherapy for Patients
With Select Stage I and II Breast Cancer
Through the Walking Forward study, Native Americans
may undergo a multiplane interstitial implant in which
HDR brachytherapy will be delivered twice a day for either 4
or 5 days. This trial will document the safety and efficacy of
this form of radiation while also documenting a number of
quality of life parameters.
A Phase II Trial of Hypofractionated External Beam
Radiation and HDR Brachytherapy
for Advanced Prostate Cancer
Through the Walking Forward study, patients with inter-
mediate- to high-risk prostate cancer will be given 6 months
of a luteinizing hormone-releasing hormone agonist either
before and/or concurrent with 3-dimensional conformal ra-
diotherapy followed by an HDR boost. The overall time to
complete radiation will be approximately 4 weeks rather
than 8 weeks.
Intensity Modulated Radiotherapy/Tomotherapy
Although external beam radiotherapy is an effective form
of radiation for many tumor sites, radiating normal tissues
can lead to complication rates. When possible, brachythera
py addresses this clinical dilemma. Unfortunately, many pa
tients are either not candidates for brachytherapy because of
location, eg, brain tumors, or patients desire a noninvasive
Helical tomotherapy is a new form of radiation treatment
delivery. In essence, a conventional linear accelerator is
placed inside a computed tomographic scanner. Rather than
radiating the patient from a limited number of static fields,
tomotherapy treats patients continuously as they slowly move
inside the radiation unit. The radiation delivered is ex
tremely conformal since multiple metal leaflets are pro
grammed to turn off and on to maximize the tumor dose
while minimizing the dose to the adjacent normal tissues.
The ability to deliver larger and fewer doses of radiation
(hypofractionation) is an advantage of both brachytherapy
and tomotherapy since normal tissue doses are minimized.
Therefore, the duration of external beam radiation can be sig
Tomotherapy Clinical Trials
Protocols have been developed at the University of Wis
consin for lung, head and neck, and prostate cancer. Where
as the overall treatment duration is about 8 weeks when
treating prostate cancer patients with conventional external
beam radiation, the treatment duration for the initial tomo
therapy prostate protocol will only take 5½ weeks, with the
last dose level requiring only 3 to 4 weeks to complete.
Through the Walking Forward study, these tomotherapy
protocols are being conducted in parallel with the Univer
sity of Wisconsin. All patients treated in Rapid City will be
entered at dose levels that have already been safely tested
and established at the University of Wisconsin.
ATM Analysis
A genetic milieu may exist that renders Native Ameri
cans more sensitive to radiation. ATM testing will be offered
for Native Americans and non-Native Americans who un
dergo radiotherapy clinical trials to assess the baseline ATM
rate and to correlate with the association between a particu
lar cancer type and also with the incidence and severity of
radiation toxicity.
Program Evaluation
Parameters that will be assessed at the end of the grant cy-
cle include number of patients entered on clinical trials,
analysis of the Patient Navigator Database that documents
each patient contact/intervention, results of the ATM anal-
ysis, and results of both surveys. Interventions that will lower
cancer mortality rates are the ultimate goal of each survey.
Ultimately, the results of the initial grant will help us to re-
fine the next series of interventions for subsequent grants.
Native Americans are rarely recruited and seldom re
tained in clinical trials. The long distances Native cancer
patients must travel to and from cancer centers providing
cancer clinical trials averages 110 miles one way, which
makes participation in traditional radiotherapy clinical trials
unlikely. In addition, the referral protocols for most clinical
trials are time sensitive (eg, patient must present for eligibil
ity criteria within a few weeks of diagnosis). CRRs actively
working within the respective tribal communities are likely
to be able to identify, educate, and subsequently increase the
number of Natives who are referred to RCRH for possible in
clusion within the radiotherapy clinical trials. At a mini
mum, the Native patients who interact with the CRRs will
be better informed to make an informed choice regarding
participation in such clinical trials.
The NCI CDRP program is a unique research program
that empowers the community-based center to develop the
multifaceted research program in conjunction with the com
prehensive cancer centers and/or national cooperative clini
Special Supplement, Volume 20, Spring 2005 69
cal trials groups of the CDRP grantee’s choosing. The coop
erative agreement mechanism encourages and ensures that
the grantees and their partners collaborate with one another
utilizing periodic meetings and also the TELESYNERGY®
telemedicine system. Incorporating aspects of the NCI navi
gator program helps build research and treatment teams to
provide new insight and solutions into the helping solve the
issue of cancer health disparities in the United States.
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70 PETEREIT et al.
Clinical Disparities in Native Americans
... American Indians in this region have worse radiation toxicities, which may result in more treatment interruptions. 21 In addition, 53% of the American Indians in this study identified the Indian Health Service (IHS) as their source of primary care. The IHS is a direct service provider financed by the US government. ...
... This may be a result of programs over the past decade aimed at reducing cancer disparities for American Indians. 21 These results suggest that future efforts to improve access to cancer care would result in equitable treatment for American Indians with HNSCC. ...
... Comprehensive programs aimed at improving cancer education, cancer screening, and cancer treatment through patient navigation have been successful in this community. 21 Funding to continue and expand these programs is critical. ...
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To examine patient characteristics, treatment modalities, and human papillomavirus (HPV) prevalence to identify potential mediators of disparities that may lead to differences in outcomes for American Indians with head and neck squamous cell carcinoma (HNSCC). Historical cohort study. Community cancer centers. We reviewed all patients older than 18 years with a new diagnosis of HNSCC in South Dakota from 1999 to 2009. We assessed tissue samples from cases of oropharyngeal cancer for the presence of HPV DNA. In total, 474 white patients were compared with 32 American Indians. American Indians experienced significantly worse survival compared with whites (hazard ratio [HR], 0.59; P = .05), even after controlling for other factors such as age, sex, distance, Charlson comorbidity index, alcohol abuse, smoking, insurance, and disease stage. American Indians had a greater risk of alcohol abuse (68% vs 42%; P = .008), current smoking (67% vs 49%; P = .03), living more than 1 hour from a cancer center (81% vs 30%; P < .001), lacking private insurance (24% vs 68%; P < .001), and late-stage disease presentation (stages III and IV) (74% vs 55%; P = .04). There were no detected differences in age, sex, medical comorbidities, tumor site, tumor grade, HPV status, time to treatment, or type of treatment received. American Indians in South Dakota with HNSCC have poorer survival compared with white patients. Once presented to a cancer center, American Indians received nearly identical treatment to white patients. Disparities in outcomes arise primarily due to sociodemographic factors and later stage at presentation.
... 18 individuals. 15 Patient navigators can be non-professionals such as lay persons or volunteers, 16,19,20,21 health professionals such as nurses or nurse practitioners [20][21][22] or social workers. [22][23][24] Patient navigation became a promising strategy to address disparities in access to prompt diagnosis and treatment of cancer, particularly among the poor and uninsured as well as to improve overall patient satisfaction. ...
... 18 individuals. 15 Patient navigators can be non-professionals such as lay persons or volunteers, 16,19,20,21 health professionals such as nurses or nurse practitioners [20][21][22] or social workers. [22][23][24] Patient navigation became a promising strategy to address disparities in access to prompt diagnosis and treatment of cancer, particularly among the poor and uninsured as well as to improve overall patient satisfaction. ...
... This summary included narratives describing how the principal investigators' participation in the CDRP affected their careers, institutions, clinical research, and communities. The importance of using narratives was exemplified in the CDRP relationship with the indigenous populations of the Lakota Sioux in the South Dakota CDRP Walking Forward program (5)(6)(7)(8). Interestingly, a recent article from Australia pointed out the importance of "yarning and story-telling" between indigenous and nonindigenous populations (9). The narrative is an approach we in health disparities research now use in outreach to health-disparities populations in the United States and globally after having learned of their value in enhancing the knowledge obtained from our efforts to improve cancer care among underserved populations (8 ...
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The burden of cancer and access to effective treatment are not experienced equally by all in the United States. For underserved populations that often access the health-care system when their cancers are in advanced disease stages, radiation oncology services are essential. In 2001, the National Cancer Institute’s (NCI’s) Radiation Research Program created and implemented the Cancer Disparities Research Partnership Program (CDRP). CDRP was a pioneering funding model whose goal was to increase participation of medically underserved populations in NCI clinical trials. CDRP’s Cooperative Agreement funding supported for awardees the planning, development, and conduct of radiation oncology clinical research in institutions not traditionally involved in NCI-sponsored research and cared for a disproportionate number of medically underserved, health-disparities populations. The awardee secured and provided support for mentorship from 1 of 2 NCI comprehensive cancer centers named in its application. Six CDRP awards were made over two 5-year funding periods ending in 2013, with the end-of-program accomplishments previously reported. With the current focus on addressing equity, diversity, and inclusion, the 6 principal investigators were surveyed, 5 of whom responded about the impact of CDRP on their institutions, communities, and personal career paths. The survey that was emailed included 10 questions on a 5-point Likert scale. It was not possible to collect patient data this long after completion of the program. This article provides a 20-year retrospective of the experiences and observations from those principal investigators that can inform those now planning, building, and implementing equity, diversity, and inclusion programs.
... Trust between American Indian (AI) community members and academic researchers is critical to the success of intervention research within these communities (Christopher, Watts, McCormick, & Young, 2008). Research has demonstrated that projects will fail when trust does not exist between tribal community members and academic researchers (Rogers & Petereit, 2005;Christopher, 2005). Consequently, health interventions and research need to be grounded in a model that emphasizes integrating the community as full and equal partners in all phases of the research process. ...
... The Walking Forward programme is a patient navigator (PN) programme created to help address the high mortality rates for American Indians (AIs) in South Dakota, USA (Kanekar & Petereit, 2009;Petereit et al., 2005). Petereit et al (2008) present early find- ings from the PN programme. ...
... A comprehensive PubMed database search for articles published up to and including April 20, 2017 using the search terms "Native American or American Indians," "radiotherapy," and "disparities" revealed articles describing the Walking Forward Program in South Dakota. 6,13,14 More recently, Guadagnolo described the consequences of decades of policies that were designed to fracture AI communities, including increased rates of unhealthy lifestyles and high-risk behaviors, low rates of physical activity, and lower cancer-screening rates, even after adjustments for income, state of residence, and education. 15 Barriers to cancer screening for the AI population include geographic remoteness (especially among reservationbased communities) and cultural barriers that manifest as a mistrust of health care providers, which contribute to disparate cancer outcomes. ...
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Introduction American Indian/Alaska Native (AI/AN) patients with cancer disproportionally present with more advanced stages of disease and have the worst cancer-specific survival rates of any racial/ethnic group in the United States. The presence of disparities in radiation therapy (RT) access for AI/AN patients has rarely been examined. Methods and materials National Cancer Institute (NCI) initiatives toward addressing AI/AN disparities were examined. Additionally, an extensive PubMed literature search for studies investigating RT access disparities in AI/AN patients was performed. Results Literature describing RT access disparities for the AI/AN patient population is sparse, revealing only 3 studies, each of which described initiatives from the Walking Forward program, the NCI Cancer Disparity Research Partnership initiative to address barriers to cancer screening among AI populations in the Northern Plains region (eg, geographic remoteness and mistrust of health care providers). This program has used patient navigation, community education, and access to clinical trials for more than 4000 AI/AN patients to combat high cancer mortality rates. Over the course of its 15-year existence, the program has resulted in patients presenting with earlier stages of disease and experiencing higher cure rates. Lung cancer, the most common cause of cancer-related mortality in AI/AN patients, is the most recent and ongoing focus of the program. Conclusion The amount of information regarding RT access in AI/AN patients is limited, with nearly all peer-reviewed published progress in this area being associated with the Walking Forward program. Further initiatives from this program will hopefully inspire similar initiatives throughout the country to reduce the barriers to optimized cancer care that these patients face. Given thesimilarities with cancer disparities of populations worldwide, the AI/AN experience should be included within the broad issue of a global shortage of cancer care among underserved populations.
... We are initiating a lung cancer project that will include education, lung cancer screening, and genomic profiling of non- small-cell-lung cancer (NSCLC) with the goal of developing targeted therapies as the death rate form NSCLs exceeds that of the non-AI population in our area. 46 ...
Low socioeconomic and health care access realities of being American Indian/Alaskan Native (AI/AN) in the United States combined with decades of data documenting poor cancer outcomes for this population provide a population nested within the United States that is analogous to the cancer care landscape of low- and middle-income countries internationally. We reviewed the medical literature with respect to cancer prevention, access to cancer treatment, and access to effective supportive and palliative care for AI/AN populations in the United States. Research confirms poorer cancer outcomes, suboptimal cancer screening, and high-risk cancer behaviors among AI/AN communities. AI/AN cancer patients are less likely to undergo recommended cancer surgeries, adjuvant chemotherapy, and radiation therapy than their White counterparts. Studies including both rural and urban survivors with AI cancer revealed barriers to receipt of optimal cancer symptom management and proportionally lower hospice use among AI/AN populations. Culturally tailored programs in targeted communities have been shown to mitigate the observed cancer-related health disparities among AI/AN communities. There is still much work to be done to improve cancer-related health outcomes in AI/AN communities, and the goals of the providers serving them corresponds with those propelling the growing interest in global oncology equity. Policy work and more funding are needed to continue to build upon the work that the Indian Health Service and established cancer-related health programs have begun in AI/AN communities.
... Ford and colleagues (13,14) conducted two reviews of barriers for underserved populations' participation in cancer treatment RCTs, in which they report a serious lack of information for Indigenous people. 'Lessons learnt' and discussion papers of barriers and/or facilitators for RCT participation have been published, but these also tend to only focus on one health area and one Indigenous population in a particular context, such as substance abuse among Native American people (15,16), cancer among Native American people (17)(18)(19) and chronic suppurative otitis media among Australian aboriginal children (20). To our knowledge there have been no reviews that specifically focus on barriers or facilitators for Indigenous peoples' participation in RCTs. ...
Issue: Many randomized controlled trials (RCTs) are conducted each year but only a small proportion is specifically designed for Indigenous people. In this review we consider the challenges of participation in RCTs for Indigenous peoples from New Zealand, Australia, Canada and the United States and the opportunities for increasing participation. Approach: The literature was systematically searched for published articles including information on the barriers and facilitators for Indigenous people's participation in health-related RCTs. Articles were identified using a key word search of electronic databases (Scopus, Medline and EMBASE). To be included, papers had to include in their published work at least one aspect of their RCT that was either a barrier and/or facilitator for participation identified from, for example, design of intervention, or discussion sections of articles. Articles that were reviews, discussions, opinion pieces or rationale/methodology were excluded. Results were analysed inductively, allowing themes to emerge from the data. Key findings: Facilitators enabling Indigenous people's participation in RCTs included relationship and partnership building, employing Indigenous staff, drawing on Indigenous knowledge models, targeted recruitment techniques and adapting study material. Challenges for participation included both participant-level factors (such as a distrust of research) and RCT-level factors (including inadequately addressing likely participant barriers (phone availability, travel costs), and a lack of recognition or incorporation of Indigenous knowledge systems. Implication: The findings from our review add to the body of knowledge on elimination of health disparities, by identifying effective and practical strategies for conducting and engaging Indigenous peoples with RCTs. Future trials that seek to benefit Indigenous peoples should actively involve Indigenous research partners, and respect and draw on pertinent Indigenous knowledge and values. This review has the potential to assist in the design of such studies.
... American Indians (AIs) appear more sensitive to fractionated radiotherapy as reported by our group. This was evident by AIs developing higher rates of G3 skin and mucosal reactions as compared to non-AI patients (10). The ATM gene has not been studied in Northern Plains AIs, a population that exhibits disproportionate burden of cancer mortality. ...
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Purpose: To identify sequence variants of the ataxia telangiectasia mutated (ATM) gene and establish their prevalence rate among American Indian (AI) as compared with non-AI cancer patients. Materials and Methods: DNA was isolated from blood samples collected from 100 AI and 100 non-AI cancer patients undergoing radiation therapy, and a blinded assessment of the ATM sequence was conducted. Quantitative PCR assessment of copy number for each exon was also performed. The main outcome measure was the prevalence of ATM variants in the two patient populations. Results: No statistically significant differences for total prevalence of ATM variants among AI and non-AI patients were found. Of the 25 variants identified, 5 variants had a prevalence of >2%, of which 4 occurred at a rate of >5% in one or both groups. The prevalence of these four variants could meaningfully be compared between the two groups. The only statistically significant difference among the groups was the c.4138C > T variant which is predicted not to affect protein function, seen in 8% of AI versus 0% of non-AI patients (P = 0.007). No exonic copy number changes were found in these patients. Conclusion: This study is the first to determine the prevalence of ATM variants in AIs.
Background: One approach to overcoming healthcare system barriers and facilitating timely access to quality care and patient satisfaction is with a patient navigator. A patient navigator is a trained person who individually assists patients, families and caregivers navigate the healthcare system barriers efficiently and effectively at any point along the care continuum, improving patient care at all levels of an organization. Objectives: To synthesize the best available evidence on the effectiveness of a patient navigator on patient satisfaction in adult patients 18 years and older in ambulatory care settings. Inclusion criteria types of participants: This review considered studies that involved adults of any ethnicity, race or gender, aged 18 years or older, regardless of diagnoses, stage of illness, whether the illness is acute or chronic or previous treatment, who had been receiving care in an ambulatory care setting. Types of intervention(s)/phenomena of interest: This review considered studies on the use of a patient navigator as an additional intervention to usual care for promoting patient satisfaction for adult patients in an ambulatory care setting. Usual care without a patient navigator was considered as a comparator. Types of studies: This review considered experimental and observational studies. Outcomes: The outcome considered was patient satisfaction. Search strategy: The literature search included published and unpublished studies in the English Language from 1990 through July 2015. A search of PubMed, CINAHL, Excerpta Medica Database (EMBASE), Academic Search Premier, Cochrane Library, PsycINFO and Health Source: Nursing/Academic Edition, Social Work Abstracts and Web of Science was conducted. A search for gray literature and electronic hand searching of relevant journals was also performed. Methodological quality: Two reviewers independently evaluated the included studies for methodological quality utilizing standardized critical appraisal instruments from the Joanna Briggs Institute. Data extraction: Standardized data extraction tools from Joanna Briggs Institute were used by two independent reviewers for data extraction. Data synthesis: A statistical meta-analysis was not possible due to heterogeneity between the included studies. Results are presented in a narrative form. Results: Four studies were included in this review, two were randomized controlled trials (RCTs), one was a quasi-experimental pre-post-test design study and one was a cohort study. The four studies showed that a patient navigator had clinical benefit for patient satisfaction, care coordination and patient access to timely healthcare services. One RCT reported a mean satisfaction score of 4.3 for navigated patients and 2.9 for non-navigated patients; P < 0.001. A second RCT showed an odds ratio 1.29; 95% confidence interval 0.92-1.82 for navigated versus non-navigated patients. The quasi-experimental pre-test-post-test study showed navigated patient satisfaction with a mean = 11.45 (standard deviation [SD], 3.69) in comparison with the non-navigated patient (mean, 14.95; SD, 1.69) (F = 11.85; P = 0.000). The cohort study demonstrated a mean satisfaction score of 90.7 for navigated patients and 85.5 for non-navigated patients; P = 0.03. The four studies showed no clinically significant results; however, the patient navigator role may promote relationships among the healthcare team, reducing barriers for patient-centered care and enhanced patient satisfaction. Conclusion: There is a paucity of evidence on the effectiveness of a patient navigator on patient satisfaction. In the four studies selected for inclusion, a patient navigator had a positive effect on patient satisfaction, although none of the studies demonstrated statistical significance with a patient navigator on patient satisfaction. The effect of a patient navigator remains questionable with differences in perceptions on the best individual for the role and the expected role perception and performance. A standardized approach to the role of the patient navigator may maximize health outcomes and positively affect the quality of life for all patients.
PURPOSE: Radiation therapy (RT) restricted to the tumor bed, by means of an interstitial implant, and lasting 4 to 5 days after lumpectomy was prospectively evaluated in early-stage breast cancer patients treated with breast-conserving therapy (BCT). The goals of the study were to determine whether treatment time can be reduced and whether elective treatment of the entire breast is necessary. MATERIALS AND METHODS: Between January 1993 and January 2000, 174 cases of early-stage breast cancer were managed with lumpectomy followed by RT restricted to the tumor bed using an interstitial implant. Each brachytherapy patient was matched with one external-beam RT (ERT) patient derived from a reference group of 1,388 patients treated with standard BCT. Patients were matched for age, tumor size, histology, margins of excision, absence of an extensive intraductal component, nodal status, estrogen receptor status, and tamoxifen use. Median follow-up for both the ERT and brachytherapy groups was 36 months. RESULTS: No statistically significant differences were noted in the 5-year actuarial rates of ipsilateral breast treatment failure or locoregional failure between ERT and brachytherapy patients (1% v 0%, P = .31 and 2% v 1%, P = .63, respectively). In addition, there were no statistically significant differences noted in rates of distant metastasis (6% v 3%, P = .24), disease-free survival (87% v 91%, P = .55), overall survival (90% v 93%, P = .66), or cause-specific survival (97% v 99%, P = .28). CONCLUSION: Accelerated treatment of breast cancer using an interstitial implant to deliver radiation to the tumor bed alone over 4 to 5 days seems to produce 5-year results equivalent to those achieved with conventional ERT. Extended follow-up will be required to determine the long-term efficacy of this treatment approach.
PURPOSE: To compare the prostate-specific antigen (PSA) relapse-free survival outcome and incidence of late toxicity for patients with early-stage prostate cancer treated at a single institution with either three-dimensional conformal radiotherapy (3D-CRT) or transperineal permanent implantation (TPI) with iodine-125 seeds. MATERIALS AND METHODS: Patients with favorable-risk prostate cancer, defined as a pretreatment PSA of less than or equal to 10.0 ng/mL, Gleason score of 6 or lower, and stage less than or equal to T2b, were selected for this analysis. Between 1989 and 1996, 137 such patients were treated with 3D-CRT and 145 with TPI. The median ages of the 3D-CRT and TPI groups were 68 years and 64 years, respectively. The median dose of 3D-CRT was 70.2 Gy, and the median implant dose was 150 Gy. Prostate-specific antigen relapse was defined according to the American Society of Therapeutic Radiation Oncology Consensus Statement, and toxicity was graded according to the Radiation Therapy Oncology Group morbidity scoring scale. The median follow-up times for the 3D-CRT and TPI groups were 36 and 24 months, respectively. RESULTS: Eleven patients (8%) in the 3D-CRT group and 12 patients (8%) in the TPI group developed a biochemical relapse. The 5-year PSA relapse-free survival rates for the 3D-CRT and the TPI groups were 88% and 82%, respectively (P = .09). Protracted grade 2 urinary symptoms were more prevalent among patients treated with TPI compared with 3D-CRT. Grade 2 urinary toxicity, which was manifest after the implant and persisted for more than 1 year after this procedure, was observed in 45 patients (31%) in the TPI group. In these 45 patients, the median duration of grade 2 urinary symptoms was 23 months (range, 12 to 70 months). On the other hand, acute grade 2 urinary symptoms resolved within 4 to 6 weeks after completion of 3D-CRT, and the 5-year actuarial likelihood of late grade 2 urinary toxicity for the 3D-CRT group was only 8%. The 5-year actuarial likelihood of developing a urethral stricture (grade 3 urinary toxicity) for the 3D-CRT and TPI groups was 2% and 12%, respectively (P < .0002). Of 45 patients who developed grade 2 or higher urinary toxicity after TPI, the likelihood of resolution or significant improvement of these symptoms at 36 months from onset was 59%. The 5-year likelihood of grade 2 late rectal toxicity for the 3D-CRT and TPI patients was similar (6% and 11%, respectively; P = .97). No patient in either group developed grade 3 or higher late rectal toxicity. The 5-year likelihood of posttreatment erectile dysfunction among patients who were initially potent before therapy was 43% for the 3D-CRT group and 53% for the TPI group (P = .52). CONCLUSION: Both 3D-CRT and TPI are associated with an excellent PSA outcome for patients with early-stage prostate cancer. Urinary toxicities are more prevalent for the TPI group and subsequently resolve or improve in most patients. In addition to evaluating long-term follow-up, future comparisons will require detailed quality-of-life assessments to further determine the impact of these toxicities on the overall well-being and quality of life of the individual patient.
A disproportionate number of cancer deaths occur among racial/ethnic minorities, particularly African Americans, who have a 33% higher risk of dying of cancer than whites. Although differences in incidence and stage of disease at diagnosis may contribute to racial disparities in mortality, evidence of racial disparities in the receipt of treatment of other chronic diseases raises questions about the possible role of inequities in the receipt of cancer treatment. To evaluate racial/ethnic disparities in the receipt of cancer treatment, we examined the published literature that addressed access/use of specific cancer treatment procedures, trends in patterns of use, or survival studies. We found evidence of racial disparities in receipt of definitive primary therapy, conservative therapy, and adjuvant therapy. These treatment differences could not be completely explained by racial/ethnic variation in clinically relevant factors. In many studies, these treatment differences were associated with an adverse impact on the health outcomes of racial/ethnic minorities, including more frequent recurrence, shorter disease-free survival, and higher mortality. Reducing the influence of nonclinical factors on the receipt of cancer treatment may, therefore, provide an important means of reducing racial/ethnic disparities in health. New data resources and improved study methodology are needed to better identify and quantify the full spectrum of nonclinical factors that contribute to the higher cancer mortality among racial/ethnic minorities and to develop strategies to facilitate receipt of appropriate cancer care for all patients.
Conference Paper
Purpose/Objective: Accelerated partial breast irradiation (APBI) as the sole radiation modality following lumpectomy is gaining interest for select early stage breast cancer patients. We present our clinical outcomes, technical details, and dosimetry with interstitial high-dose rate (HDR) APBI. Materials/Methods: From 11/2000 to 1/2003, 163 pts underwent HDR-APBI at our institution (142 interstitial). Selection criteria included tumors 5mm (-)margins had local recurrence outside the target volume 19 months after brachytherapy treated with 10 catheters, 2 planes, and 97cc treatment volume. Conclusions: Our results demonstrate that wide volume breast brachytherapy can be successfully delivered with high quality assurance and is well-tolerated as an alternative to whole breast radiation for patients treated with breast conservation therapy with excellent cosmesis and minimal acute toxicity. A 3D CT-based treatment planning approach is technically feasible and allows improved target volume delineation and optimal coverage relative to conventional orthogonal film dosimetry. Additional follow-up will be required to determine the long-term efficacy in this cohort and a randomized trial comparing APBI with conventional external beam whole breast irradiation is needed.
This excerpt from the book Cancer Prevention in Diverse Populations: Cultural Implications for the Multidisciplinary Team (2nd ed.), edited by Marilyn Frank-Stromborg, EdD, JD, FAAN, and Sharon J. Olsen, MS, RN, AOCN®, and excerpted by Jeannine Brant, RN, MS, AOCN®, is part of a series of clinically relevant reprints that will appear periodically in the Clinical Journal of Oncology Nursing.
Twelve published clinical results of radical radiotherapy of head and neck cancer have been reviewed, seven of them with fresh multivariate analyses, to determine the magnitude of time factors relating local control to overall time. In all but two of the data sets a significant loss of local control was observed with prolongation. The median rate of loss was 14% in only 1 week, the range 3 to 25%. This corresponds to a median loss of 26% in 2 weeks (5-42%). These results are comparable with other, less detailed information. Whether these significant losses are due to proliferation of tumor cells or to other causes such as physician selection, it is clear that modest prolongation is associated with a lower chance of local control.