Article

Phase II Study: Integrated Palliative Care in Newly Diagnosed Advanced Non-Small-Cell Lung Cancer Patients

Massachusetts General Hospital, Boston, Massachusetts, United States
Journal of Clinical Oncology (Impact Factor: 18.43). 07/2007; 25(17):2377-82. DOI: 10.1200/JCO.2006.09.2627
Source: PubMed

ABSTRACT

To assess the feasibility of early palliative care in the ambulatory setting in patients with newly diagnosed advanced non-small-cell lung cancer (NSCLC).
Patients were eligible if they had a performance status of 0 to 1 and were within 8 weeks of diagnosis of advanced NSCLC. Participants received integrated care from oncology and palliative care throughout the course of their disease. Participants were scheduled to meet with the palliative care team (PCT) and complete quality-of-life (QOL) and mood questionnaires monthly for 6 months. The study was deemed feasible if 64% of patients completed at least 50% of their scheduled visits and QOL assessments.
Fifty-one patients were enrolled onto the trial. One died within 72 hours and was not assessable. Ninety percent (95% CI, 0.78 to 0.96) of study participants complied with at least 50% of the palliative care visits. Eight-six percent (95% CI, 0.73 to 0.94) of the participants met the full feasibility requirements by both meeting with the PCT and completing QOL assessments at least 50% of the time. QOL and mood analyses confirmed the high symptom burden in patients with newly diagnosed advanced NSCLC. At least 50% of participants experienced some degree of shortness of breath, cough, difficulty breathing, appetite loss, weight loss, or unclear thinking at their baseline assessment. More than one third of patients had a probable mood disorder at baseline.
Integrated palliative and oncology care is feasible in ambulatory patients with advanced NSCLC.

Full-text

Available from: Susan D Block, Sep 28, 2015
Phase II Study: Integrated Palliative Care in Newly Diagnosed
Advanced Non–Small-Cell Lung Cancer Patients
Jennifer S. Temel, Vicki A. Jackson, J. Andrew Billings, Constance Dahlin, Susan D. Block, Mary K. Buss,
Patricia Ostler, Panos Fidias, Alona Muzikansky, Joseph A. Greer, William F. Pirl, and Thomas J. Lynch
ABSTRACT
Purpose
To assess the feasibility of early palliative care in the ambulatory setting in patients with newly
diagnosed advanced non–small-cell lung cancer (NSCLC).
Patients and Methods
Patients were eligible if they had a performance status of 0 to 1 and were within 8 weeks of
diagnosis of advanced NSCLC. Participants received integrated care from oncology and palliative
care throughout the course of their disease. Participants were scheduled to meet with the
palliative care team (PCT) and complete quality-of–life (QOL) and mood questionnaires monthly for
6 months. The study was deemed feasible if 64% of patients completed at least 50% of their
scheduled visits and QOL assessments.
Results
Fifty-one patients were enrolled onto the trial. One died within 72 hours and was not assessable.
Ninety percent (95% CI, 0.78 to 0.96) of study participants complied with at least 50% of the
palliative care visits. Eight-six percent (95% CI, 0.73 to 0.94) of the participants met the full
feasibility requirements by both meeting with the PCT and completing QOL assessments at
least 50% of the time. QOL and mood analyses confirmed the high symptom burden in
patients with newly diagnosed advanced NSCLC. At least 50% of participants experienced
some degree of shortness of breath, cough, difficulty breathing, appetite loss, weight loss, or
unclear thinking at their baseline assessment. More than one third of patients had a probable
mood disorder at baseline.
Conclusion
Integrated palliative and oncology care is feasible in ambulatory patients with advanced NSCLC.
J Clin Oncol 25:2377-2382. © 2007 by American Society of Clinical Oncology
INTRODUCTION
Patients with advanced non–small-cell lung cancer
(NSCLC) experience physical and emotional dis-
tress from the moment of diagnosis. Although the
majority of patients have physical symptoms attrib-
utable to their cancer, even those who do not have
such symptoms experience distress and anxiety re-
lated to their incurable disease.
1
With more than
160,000 patients dying as a result of NSCLC each
year, many patients and families suffer from the
physical, emotional, and social ramifications of deal-
ing with a terminal diagnosis.
2
Few studies guide clinicians on how to best
provide for the psychosocial needs of patients and
families facing a life-threatening illness. Most re-
search has focused on care at the very end of life
(EOL). It has been shown that hospice care can
improve the quality of EOL care and death.
3,4
The
care provided by hospice allows for aggressive
symptom management and psychosocial and
spiritual support for patients and their families.
5
Despite the benefits of hospice care, the majority
of cancer patients are still referred to hospice very
late in the course of their disease.
6
With the development of novel and less toxic
cancer therapies, more and more patients are receiv-
ing multiple lines of chemotherapy. In the last sev-
eral years, the number of US Food and Drug
Administration–approved agents for second-line
therapy of advanced NSCLC has increased from one
to three.
7-9
The increased availability of additional
therapies has translated into more patients receiving
chemotherapy near the end of their life.
10
However,
patients receiving chemotherapy are not eligible for
hospice care, leaving many patients and families
struggling without the specialized symptom man-
agement and support available through hospice and
palliative care programs.
From the Massachusetts General
Hospital; and the Dana-Farber Cancer
Institute, Boston, MA.
Submitted September 28, 2006;
accepted March 16, 2007.
Supported by an investigator-initiated
research grant from Amgen (J.S.T.).
Presented in part at the 41st Annual
Meeting of the American Society of
Clinical Oncology, Orlando, FL, May
13-17, 2005, and the 11th World Lung
Cancer Conference, Barcelona, Spain,
July 3-6, 2005.
Authors’ disclosures of potential con-
flicts of interest and author contribu-
tions are found at the end of this
article.
Address reprint requests to Jennifer S.
Temel, MD, Massachusetts General
Hospital, Yawkey 7B, 55 Fruit St,
Boston, MA 02114; e-mail: jtemel@
partners.org.
© 2007 by American Society of Clinical
Oncology
0732-183X/07/2517-2377/$20.00
DOI: 10.1200/JCO.2006.09.2627
JOURNAL OF CLINICAL ONCOLOGY
ORIGINAL REPORT
VOLUME 25 NUMBER 17 JUNE 10 2007
2377
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Page 1
Symptom management and psychosocial support for patients
with advanced cancer and their families must be a part of the contin-
uum of care, not just once life-prolonging therapies fail. Additionally,
patients who have an understanding of their life expectancy and par-
ticipate in advanced care planning are more likely to accept hospice
care at the EOL.
11,12
Thus, providing more comprehensive support for
patients throughout the course of their disease may not only benefit
their current health status but also allow for a more timely transition to
hospice care. A new delivery model of integrating palliative and oncol-
ogy care can bridge the gap between cancer-directed and comfort-
oriented therapies in advanced cancer patients.
Recent studies describe the development of ambulatory palliative
care practices within oncology, but none include the longitudinal,
continuous participation of palliative care in terminal patients begin-
ning at the time of diagnosis.
13,14
We performed a pilot study to assess
the feasibility of integrating palliative care with routine oncology care
in patients with advanced NSCLC, a homogeneous cohort of patients
with a limited life expectancy and high symptom burden. Before
beginning this study, the participating hospitals did not have an on-
cology ambulatory palliative care clinic. Therefore, the ease of devel-
oping and implementing such a clinic and its acceptability to patients,
families, and clinicians was unknown. Although the participating hos-
pitals did have some experience collecting QOL data as part of chem-
otherapy trials, neither had performed a supportive care trial that
required data collection outside of chemotherapy treatment sched-
ules. The primary goal of this study was to assess the feasibility and
acceptability of this novel model of care and the ability to collect
patient self-assessment questionnaires in a large, academic cancer
center clinic.
PATIENTS AND METHODS
Patient Selection
Patients within 8 weeks of diagnosis of advanced NSCLC (stage IIIB with
pleural or pericardial effusions or stage IV) confirmed by histology or cytology
were eligible for this study. Other eligibility requirements included age more
than 18 years, Eastern Cooperative Oncology Group (ECOG) performance
status 0 to 1, and ability to read and respond to questions in English. Partici-
pants were also required to receive their cancer care at a participating Dana-
Farber/Partners Cancer Center (DF/PCC) institution. All patients provided
written informed consent before participation.
Integrated Palliative Care
The Palliative Care Services at DF/PCC provide comprehensive interdis-
ciplinary care to patients and families facing serious illnesses. The ambulatory
palliative care team (PCT) consisted of board-certified palliative care physi-
cians and advanced practice nurses. Patients in this pilot study were scheduled
to meet with the PCT monthly. To facilitate compliance with palliative care
visits, a scheduling system that allowed cancer center appointments to be
linked with both an oncology and palliative care provider was developed.
Because some patients required more frequent visits with the PCT, either the
patients or the palliative care clinician could request and schedule more fre-
quent visits at their discretion. If study patients were admitted to the hospital,
the PCT saw them on a daily basis throughout their admission.
The study protocol contained guidelines to provide consistency to the
palliative care intervention. All visits with the PCT included a focused
physical exam, psychosocial and spiritual history, symptom and functional
status assessment, and the establishment of a palliative care plan (Table 1).
The palliative care plan was recorded in the patient’s electronic medical
record and included a problem list, medication changes, and referrals to other
care providers.
QOL and Symptom Assessments
Several questionnaires that have been validated in patients with ad-
vanced NSCLC were used to assess QOL and symptom status. Questionnaires
were self-administered in the clinic. If patients were unable to come into the
clinic but were still willing to complete the questionnaires, they were com-
pleted over the telephone with a study nurse. Questionnaires completed within
20 days of the 3- and 6-month time points were considered acceptable for
analysis. The results of the self-assessment questionnaires were not provided to
the oncologist or PCT and thus did not impact patient care during the study.
We used the Functional Assessment of Cancer Therapy-Lung (FACT-L)
to measure health-related QOL. The FACT Measurement System question-
naires evaluate health-related QOL in cancer patients.
15
The response format
consists of a five-point Likert scale that assesses QOL of the previous week. A
26-item version of the questionnaire, the FACT-General (FACT-G), addresses
multiple QOL dimensions, including physical, functional, emotional, and
social well-being. The FACT-L consists of the FACT-G plus a Lung Cancer
Subscale (LCS), addressing seven symptoms specific to lung cancer, including
cough, shortness or breath, and chest discomfort.
16
The FACT-L was scored
using published guidelines.
17
The optional question regarding satisfaction
with sex life was eliminated to allow for ease of scoring. A higher score on the
total FACT-L or any of its components indicates better QOL. A score of less
than 24 on the LCS is considered symptomatic.
8,18
We also administered the Hospital Anxiety and Depression Scale
(HADS), a 14-item self-report instrument designed to limit the contribution
of somatic symptoms in assessing mood and anxiety in medically-ill patients.
19
It is the most widely used instrument to measure depressive symptoms in
cancer patients.
20
Two seven-item subscales assess depression and anxiety in
the preceding week. The score on each subscale ranges from 0 to 21 and a score
of 8 or above is suggestive of a possible case of depression or anxiety.
Feasibility Criteria for Integrated Palliative Care
The primary aim of our study was to determine the feasibility of early
palliative care and longitudinal QOL assessments in patients with advanced
NSCLC. Our target accrual was 50 patients from DF/PCC. Participants were
scheduled to meet with the palliative care team and complete QOL assessments
once per month for 6 months or until death or hospice referral. Further study
of this care model would be warranted if at least 32 of the 50 patients (64%)
both (1) met with the palliative care team and (2) completed the FACT-L
questionnaire at least 50% of the time they were scheduled to do so. The
proposed cutoffs for adherence to palliative care and the quality of life
Table 1. Components of Palliative Care Guidelines
Area Elements
Psychosocial and spiritual
history
Illness understanding
Information preferences
Social history
Religion and spirituality
Financial issues
Care preferences and advanced care
planning
Coping and supports
Symptom and functional status
assessment
Pain
Pulmonary (cough, dyspnea)
GI (nausea/vomiting, decreased appetite/
weight loss, constipation)
General (fatigue, sleep disturbance)
Emotional (depression, anxiety)
Ability to perform activities of daily living
Assessment and palliative
care plan
Construct a problem list
Care plan for identified problems
including diagnostic efforts, treatment
plan and referrals
Determine follow-up plan for patient and
family
Temel et al
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Page 2
assessments were chosen on the basis of the level of disability in the patient
population and of previous literature of palliative care intervention studies
demonstrating significant challenges in recruitment, retention, and com-
pliance with study procedures.
21,22
For example, recent longitudinal inves-
tigations of palliative care for advanced cancer patients showed high
attrition (39%) and poor compliance with completing study assessments
(approximately 60%).
23,24
Although we expected that adherence rates
would be somewhat higher in our sample because of the integration of
palliative care services early in the course of the disease, we chose these
proposed criteria to be consistent with the extant literature.
Statistical Analysis
Because of the varying survival times in patients with advanced NSCLC,
we determined the individual compliance of each participant for as long as he
or she was alive before receiving hospice care. Specifically, for each participant,
we calculated the ratio of the number of palliative care visits to months of
survival before hospice referral. Patients whose ratios were greater than 0.50,
indicating at least 50% participation in integrated palliative care, were consid-
ered compliant with the intervention. To describe the compliance of the entire
sample, we calculated the rate of compliant patients over the total number of
patients. This method allowed us to include and analyze data on all of the
participants rather than only those who reached a specified survival time.
Finally, we calculated that if at least 32 subjects met the feasibility criteria, there
was at least a 95% chance that the true response rate was at least 50%.
We also prospectively evaluated QOL (FACT-L), symptom burden
(LCS), mood (HADS), and overall survival. Specifically, we first calculated
symptom frequencies, means and standard deviations to estimate patient
QOL, degree of symptom burden, and mood at baseline and 3 and 6 months.
We used repeated-measures analysis of variance to examine changes in QOL
and LCS scores across the three time points and conducted linear regression
analyses to explore the relationship between symptom burden scores on the
LCS and number of palliative care visits. Survival time was calculated from the
date of consent to the date of death using the Kaplan-Meier method. Patients
who were alive on the date of last follow-up were censored on that date.
RESULTS
From October 2003 and June 2005, 51 patients were accrued to the
study. One patient who died within 72 hours of signing informed
consent was not assessable. Four other patients withdrew from the
study, but their data are included in this analysis. Of these, two patients
cited refusal to meet with the PCT as the reason for withdrawal; one
patient withdrew at the request of his primary care physician; and one
transferred her care to another facility. At the time of data analysis,
eight patients were alive and one was lost to follow-up and censored at
the last known time point. Baseline characteristics are shown in Table
2. The median survival of the entire cohort was 9.0 months with a
range of 1.2 to 32.4 months and a 1-year survival of 36%.
Study Feasibility
Ninety percent of the participants (45 of 50) completed at least
50% of their scheduled appointments with the PCT in the 6-month
study period (Table 3). Ninety-two percent of the participants (46 of
50) completed at least 50% of their monthly QOL assessments and
thus met criteria for compliance with the FACT-L. The overall study
compliance with both the palliative care visits and the QOL assessment
was 86% (43 of 50).
Palliative Care Involvement
Although the primary goal of the study was feasibility, the PCT
became active participants in the care of the study patients. Therefore,
study participants and/or the PCT could choose to meet more than
once per month depending on patient care needs. The number of visits
with the PCT ranged from zero to 17, with a median of six. 20% of the
participants met with the PCT eight or more times (Fig 1). All partic-
ipants surviving greater than 6 months choose to continue to meet
with the PCT regularly after the measurement period was over.
Questionnaire Completion
Baseline, 3-month, and 6-month QOL and mood data are shown
in Table 4. Ninety-eight percent of patients (49 of 50) completed the
baseline FACT-L. At 3 months, 70% of the participants (28 of 40) alive
and not receiving hospice care completed the FACT-L within the
required time frame. At the 6-month time point, 64% of patients (21
of 33) alive and not receiving hospice care completed the FACT-L on
time. Completion of the HADS at baseline, 3 months, and 6 months
was slightly lower at 96%, 65%, and 61% respectively.
Symptom Assessment
Study participants were symptomatic at their baseline QOL as-
sessment, with a median LCS score of 19.9 (standard deviation, 4.3;
Table 4). Despite the ability of patients to meet with the PCT more
frequently than once per month, there was no association between the
baseline QOL score and the number of visits with the PCT. FACT-L
and LCS scores remained fairly stable throughout the study period.
Thirty-seven and a half percent of study participants (18 of 48) had a
probable mood disorder at baseline. The rates of depressive and anx-
iety symptoms were high, 21% and 31% respectively, and confirm
previous work in this area.
1
The rate of depressive symptoms re-
mained high throughout the course of the study, with at least 15% of
patients reporting symptoms at each time point.
The breakdown of the baseline LCS is shown in Table 5. The only
symptom in which the majority of patients were asymptomatic at
baseline was “tightness in chest.” At least 50% of participants reported
some degree of symptoms for shortness of breath, cough, difficulty
breathing, appetite loss, weight loss, and unclear thinking. At least
20% of patients reported severe symptoms of shortness or breath and
appetite loss. There were no significant differences in the rates of
symptom severity on the LCS over time.
Table 2. Patient Characteristics (N 50)
Variable No. %
Age, years
Median 64.5
Range 45-81
Race, white 50 100
Sex, female 31 62
PS
01122
13876
212
Stage
IIIb 3 6
IV 47 94
Initial therapy
Chemotherapy 32 64
Oral EGFR-TKI 6 12
Radiation 12 24
Abbreviations: PS, Eastern Cooperative Oncology Group performance status;
EGFR-TKI, epidermal growth factor receptor-tyrosine kinase inhibitor.
Integrated Palliative Care in Advanced NSCLC
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DISCUSSION
In a 1998 Special Article, ASCO stated, “The role of the oncologist and
the care team is not simply to treat cancer, but to provide comprehen-
sive palliative and anticancer therapy throughout the course of an
illness.”
25
Although other organizations such as the Institute of Med-
icine and the WHO have published similar recommendations, few
strides have been made in providing this form of care to our pa-
tients.
26,27
The traditional dichotomy between cancer-directed ther-
apy and palliative care hinders the provision of comprehensive care for
patients and their families. It is essential that we identify how to
provide these services to our patients in a more timely fashion
throughout the course of their illness, rather than solely at the EOL.
One of the main barriers to accomplishing the aim stated by
ASCO is the lack of evidence that palliative and oncology care can
be coordinated from the outset of a cancer diagnosis. Our pilot
study shows that integrating palliative and oncology care is feasible
in patients with newly diagnosed advanced NSCLC. Participants in
this study were expected to meet with the PCT at least every other
month during the study period. The actual results far exceeded our
expectations, as the majority of patients met with the team at least
monthly. Only two patients withdrew from the study, citing that
they did not want to meet with the PCT. No oncologists asked that
their patient be removed from the study, although a primary care
physician did request that one patient withdraw. This suggests that
the integrated care model was acceptable to the majority of patients
and involved clinicians.
The study also demonstrates the feasibility of collecting longitu-
dinal QOL data at specified time points outside of a treatment-related
clinical trial. The precise timing of assessments is an important ele-
ment in QOL analysis and treatment studies that include QOL time
the collection of data to chemotherapy cycles or radiation schedules.
28
Although collection of QOL data outside of these treatment schedules
has proven to be a challenge in previous investigations, compliance
with the QOL assessments in our study was quite high.
23,24
The QOL
and mood data from our study are consistent with prior reports and
confirm the high symptom burden and emotional distress in patients
with newly diagnosed metastatic disease.
1,18,29,30
This study adds a new perspective to other studies that have
sought to provide an integrated care model. Several of these studies,
including Project Safe Conduct and Project Enable, were mainly dem-
onstration projects for the development of palliative care teams.
31,32
Other studies have sought to provide integrated or simultaneous care
for cancer patients, but have been limited in the scope or timing of the
palliative care involvement. For example, in one study, participants
interacted exclusively with a social worker, and visits occurred only
three times during the 1-year program.
33,34
Other studies have fo-
cused only on patients participating in phase I or II clinical trials,
which often includes patients who are already at the end stages of
life.
35,36
Our study entailed longitudinal and frequent palliative care
Table 4. FACT-L, LCS, and HADS Results
Scale Baseline 3 Months 6 Months
QOL, No. of patients 49 28 21
FACT-L
Mean 94.8 94.1 97.2
SD 16 14.6 15.7
Range 54-120 67-126 61-125
LCS†
Mean 19.9 20.6 20.4
SD 4.3 3.3 4.0
Range 11-28 13-27 13-27
HADS‡, No. of patients 48 26 20
Anxiety
No. 15 2 3
%31815
Depression
No. 10 5 3
%211915
Abbreviations: FACT-L, Functional Assessment of Cancer Therapy Lung;
LCS, Lung Cancer Subscale; HADS, Hospital Anxiety and Depression Scale;
SD, standard deviation; QOL, quality of life.
Of a total score 132 (omitted optional question regarding sex life for ease of
scoring) with higher scores indicating better QOL.
†Of a total score of 28 with high scores indicating fewer symptoms.
‡Scores 8 probable case of depression or anxiety.
Table 3. Compliance With Palliative Care Visits and FACT-L
Variable Median Range
Compliance Rates
95% CINo. Compliant Total No. %
Palliative care 6 0-17 45 50 90 0.78 to 0.96
FACT-L 5 1-7 46 50 92 0.80 to 0.97
Palliative care and FACT-L 43 50 86 0.73 to 0.94
Abbreviation: FACT-L, Functional Assessment of Cancer Therapy-Lung.
Percentage
No. of Visits
0
5
10
15
20
25
30
None 2-3 4-5 6-7 8
Fig 1. Palliative care visits during the 6-month study period.
Temel et al
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visits beginning at the time of diagnosis, and therefore truly represents
an innovative, novel integrated care model.
A few limitations of this study deserve comment. First, we did not
collect data on the number of patients who were offered study partic-
ipation and then declined, and it is possible that our study population
is not generalizable. However, the median age, median survival, and
treatments received by the study participants are all consistent with
patient characteristics of those enrolled in clinical trials nationally.
37
Our baseline QOL data is also consistent with published chemother-
apy trials that include QOL assessments.
29,30,38
Second, we did not
collect data on the reasons for missing or incomplete QOL and mood
assessments. Lastly, although we provided palliative care guidelines in
the protocol, we did not prospectively collect data on the PCT’s in-
volvement in specific domains or their associated interventions. Al-
though the involvement of palliative care needs to be somewhat
flexible to meet the varying needs of patients and families, it would be
useful to gain insight into which components of their care were most
frequently provided in this patient population.
Our current study demonstrates that palliative care can play a
role in the care of patients who are living with incurable NSCLC.
However, key questions remain about whether and how patients ben-
efited from the care they received from the palliative care team. In addition
to cancer-related symptoms and health-related QOL, important out-
comes that need to be measured include family caregiver satisfaction
with care, prognostic understanding, hospice referrals and length of
stay in hospice, timing of orders to forgo cardiopulmonary resuscitation
and life-sustaining interventions, and the use of other aggressive measures
at the EOL.
10
To assess the impact of integrated care on these significant
outcomes, we are currently performing a randomized study of integrated
versus standard palliative care in patients with advanced NSCLC.
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS
OF INTEREST
Although all authors completed the disclosure declaration, the following
authors or their immediate family members indicated a financial interest.
No conflict exists for drugs or devices used in a study if they are not being
evaluated as part of the investigation. For a detailed description of the
disclosure categories, or for more information about ASCO’s conflict of
interest policy, please refer to the Author Disclosure Declaration and the
Disclosures of Potential Conflicts of Interest section in Information
for Contributors.
Employment: N/A Leadership: N/A Consultant: N/A Stock: N/A
Honoraria: N/A Research Funds: Jennifer S. Temel, Amgen Testimony:
N/A Other: N/A
AUTHOR CONTRIBUTIONS
Conception and design: Jennifer S. Temel, Vicki A. Jackson, J. Andrew
Billings, Constance Dahlin, Susan D. Block, Mary K. Buss, Thomas J.
Lynch
Provision of study materials or patients: Jennifer S. Temel, Panos
Fidias, Thomas J. Lynch
Collection and assembly of data: Jennifer S. Temel, Patricia Ostler,
William F. Pirl
Data analysis and interpretation: Jennifer S. Temel, J. Andrew Billings,
Alona Muzikansky, Joseph A. Greer, William F. Pirl
Manuscript writing: Jennifer S. Temel, J. Andrew Billings, Joseph A.
Greer, William F. Pirl, Thomas J. Lynch
Final approval of manuscript: Jennifer S. Temel, Vicki A. Jackson, J.
Andrew Billings, Constance Dahlin, Susan D. Block, Mary K. Buss,
Patricia Ostler, Panos Fidias, Alona Muzikansky, Joseph A. Greer,
William F. Pirl, Thomas J. Lynch
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Table 5. Severity of Lung Cancer Symptoms at Baseline
Symptom
Asymptomatic (score 4)
Less Symptomatic
(score 2–3)
Most Symptomatic
(score 0 –1)
No. % No. % No. %
Shortness of breath (n 50) 15 30 25 50 10 20
Cough (n 49)
17 34 27 54 5 10
Tightness in chest (n 50) 26 52 22 44 2 4
Difficulty breathing (n 50) 12 24 29 58 9 18
Appetite loss (n 49)
14 28 23 46 12 24
Weight loss (n 50) 25 50 19 38 6 12
Clear thinking (n 50) 18 36 26 52 6 12
NOTE. Measured using the Lung Cancer Subscale of the Functional Assessment of Cancer Care-Lung instrument, with higher scores indicating fewer symptoms.
One patient did not complete question on cough and appetite loss.
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  • Source
    • "To our knowledge it is the first trial to investigate ‘early SPC’ for patients with a broad spectrum of cancer diagnosis, and the first trial to investigate screening-based referral to SPC. In addition it is the first to provide detailed information about the specific interventions given by the SPC centres; a knowledge that has been requested [30]. "
    [Show abstract] [Hide abstract] ABSTRACT: Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to 'early SPC'. DanPaCT is a clinical, multicentre, parallel-group superiority trial with balanced randomisation (1:1).The planned sample size is 300 patients. Patients are randomised to specialised palliative care (SPC) plus standard treatment versus standard treatment. Consecutive patients from oncology departments are screened for palliative needs with a questionnaire if they: a) have metastatic cancer; b) are 18 years or above; and c) have no prior contact with SPC. Patients with palliative needs (i.e. symptoms/problems exceeding a certain threshold) according to the questionnaire are eligible. The primary outcome is the change in the patients' primary need (the most severe symptom/problem measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)). Secondary outcomes are other symptoms/problems (EORTC QLQ-C30), satisfaction with health care (FAMCARE P-16), anxiety and depression (the Hospital Anxiety and Depression scale), survival, and health care costs. Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with a broad spectrum of cancer diagnosis.Trial registration: Current controlled Trials NCT 01348048.
    Full-text · Article · Oct 2013 · BMC Palliative Care
  • Source
    • "Although more recent reports suggested that patients are being seen earlier by specialist palliative care services, there is still uncertainty about the most appropriate time to involve a palliative care service. There is growing emphasis on an integrated approach with palliative care being delivered together with standard or even investigational treatments [27]. Rather than trying to determine timing of referral for palliative care in relation to prognosis, a focus on the needs of the patient and their family is advocated [10] "
    Full-text · Article · Jul 2009 · Pain
  • Source
    • "The approach was essentially a " both –and " (as opposed to " either–or " ) model in which there would be a smooth transition from mostly anticancer treatment to mostly palliative care (Byock, 2000). Models with some similar features have been called integrated (Temel et al., 2007), concurrent, or simultaneous care (Meyers & Linder, 2003; Pitorak et al., 2003; Byock et al., 2006). "
    [Show abstract] [Hide abstract] ABSTRACT: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.
    Full-text · Article · Apr 2009 · Palliative and Supportive Care
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