Recruitment and retention of human participants in cancer clinical trials remains challenging for all investigators. Nurse Practitioners (NPs) are in a prime position to discuss, educate and refer patients to clinical trials as many NPs work in ethnically and geographically diverse primary care settings in the U.S., yet they remain an untapped resource. We examined NPs' general attitudes toward cancer clinical trial recommendations and assessed their willingness to recommend such trials
We randomly surveyed 455 primary care NPs in the state of Pennsylvania during 2008 with an adjusted response rate of 55.3%. Descriptive statistics were used to characterize NPs' demographic and practice characteristics, and logistic regression was used to assess the relative influence of the various attitudes and beliefs on the likelihood that the NP would bring up clinical trials as a treatment option.
NPs were more likely to bring up the topic of clinical trials with at least some patients if they were comfortable discussing treatment options with their cancer patients (OR=4.29, p=0.001), were comfortable discussing options of entering a clinical trial for treatment (OR=3.54, p=0.003), had adequate time during patients' visit to explain clinical trials (OR=3.40, p=0.008), and if they believed that patients in clinical trials were receiving the best medical treatment (OR=3.34, p=0.019). NPs who were comfortable discussing cancer clinical trials were almost 5 times more likely to think clinical trials were useful (OR=4.70; 95% CI=1.81-12.19; p=0.001). Nearly three-quarters (72.6%) of the entire responder sample reported three or more ethical concerns associated with clinical trials, including issues of randomization, informed consent, and patient burden.
NPs are willing to recommend clinical trials but need more education about the benefits and burdens of clinical trials, the associated ethical concerns, and evidence regarding the translatability of research to clinical practice to increase their knowledge and comfort level with discussing clinical trials.
"Participants’ self-identified perseverance and their need to finish what they had started was one of the important contributors to their continued clinical trial participation. Ulrich cites participants’ determination to not give in and continue with the trial as a ‘psychological benefit’ to them
. Participants’ determination to finish the trial, no matter what, may speak to the type of individuals that enroll in clinical trials. "
[Show abstract][Hide abstract] ABSTRACT: Palliative care is a vital component of patient-centered care. It has increasingly become central to the management and care of seriously ill patients by integrating physical, psychosocial, and spiritual supportive services. Through qualitative inquiry, this paper examines cancer patients’ perceptions of the process and outcomes of the pain and palliative care consultative services they received while enrolled in a clinical trial.
A qualitative analysis of open-ended questions was conducted from a sub-sample of patients (n = 34) with advanced cancers enrolled in a randomized controlled trial exploring the efficacy of a palliative care consult service. Two open-ended questions focused on patient perceptions of continued participation on their primary cancer clinical trials and their perceptions of interdisciplinary communication.
Three overarching themes emerged when asked whether receiving pain and palliative care services made them more likely to remain enrolled in their primary cancer clinical trial: patients’ past experiences with care, self-identified personal characteristics and reasons for participation, and the quality of the partnership. Four themes emerged related to interdisciplinary communication including: the importance of developing relationships, facilitating open communication, having quality communication, and uncertainty about communication between the cancer clinical trial and palliative care teams.
Our findings suggest the importance of qualitative inquiry methods to explore patient perceptions regarding the efficacy of palliative care services for cancer patients enrolled in a cancer clinical trial. Validation of patient perceptions through qualitative inquiry regarding their pain and palliative care needs can provide insight into areas for future implementation research.
NIH Office of Human Subjects Research Protection OHSRP5443 and University of Pennsylvania 813365
BMC Palliative Care 09/2014; 13(1):43. DOI:10.1186/1472-684X-13-43 · 1.78 Impact Factor
"Involving participants in cancer clinical trials usually has been associated with arguments for all investigators. Women with cancer have a greater risk for participation in inappropriate research because they may seek every tool for treating their disease (6, 32). In recent years complementary medicine are frequently used for cancer care in the Middle East without enough approved outcomes (33). "
[Show abstract][Hide abstract] ABSTRACT: Background: Research in reproductive health (RH) has been located in the core of women’s health research. Providing accurate information through conducting scientific and controlled research is essential, but increased number of research in the world especially in developing countries in RH area in order to introduce advanced technologies has been resulted in much unethical, illegal and abusive research on women, which needs particular attention to ethical issues by the practitioners who are involved in RH research.
Objective: This study was conducted to develop a practical ethical framework for RH research.
Materials and Methods: 45 expert academics and clinicians in various disciplines included in a three rounds Delphi study through purposeful sampling method. In round 1 Delphi data were gathered using open-ended questions by e-mail and answers were analyzed by conventional content analysis and the findings merged and validated with the results of a thorough literature review. Face and content validity index were determined in round 2 Delphi and consensuses were attained in round 3.
Results: Emerged categories were 1) management of the research process 2) protection of participants’ rights 3) third party consent 4) gender sensitive research and 5) conflict of interest.
Conclusion: This study has provided a practical ethical framework according to the socio-cultural context of Iran for all practitioners who are involved in research on women. Adherence to this framework may protect practitioners against unethical and illegal lawsuits and help them to respect their clients’ reproductive rights.
Iranian Journal of Reproductive Medicine 01/2013; 11(1):31-8. · 0.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background:
Japanese physicians' attitudes regarding the education of nurse practitioners (NPs) are not well described.
Participants and methods:
A survey was mailed to 1,094 board members of the Japanese Society of Clinical Oncology (JSCO) and the Japanese Primary Care Association (JPCA), and the directors of the clinical training program for physicians. The physicians of JSCO were classified as the cancer specialist group, and both the board members of JPCA and the directors of the clinical training program for physicians constituted the general physician group. We compared the responses of cancer specialists and general physicians.
The survey response rate was 25.9% (69 of 266) in the cancer specialist group and 19.4% (161 of 828) in the general physician group. The median age of respondents was 53 and 55 years, respectively, of which 84 and 79%, respectively, were men. We found that the percentages of respondents who considered NP education necessary were almost identical in the 2 groups (r = 0.898, p < 0.0001). Education items considered necessary for NPs by >80% respondents in both groups included many symptoms, emergency management, basic procedures, general screening, palliative care including management against adverse effects, health education, and communication. More cancer specialists than general physicians (p < 0.01) expected NPs to be educated in multidisciplinary practice and palliative care, including management against adverse effects.
Our study suggests that cancer specialists expect NPs to provide symptom management and psychosocial support, clarify information, provide education, and work as a member of a multidisciplinary team.
International Journal of Clinical Oncology 08/2012; 18(5). DOI:10.1007/s10147-012-0460-2 · 2.13 Impact Factor
Anastassia Negrouk, Denis Horgan, Alessandra Gorini, Ilaria Cutica, Lada Leyens, Sebastian Schee Genannt Halfmann, Gabriella Pravettoni,
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