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Supportive Care in Cancer

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01-08-2011 | Original Article

Enhancing decision making about participation in cancer clinical trials: development of a question prompt list

Authors: Richard F. Brown, Elyse Shuk, Natasha Leighl, Phyllis Butow, Jamie Ostroff, Shawna Edgerson, Martin Tattersall

Published in: Supportive Care in Cancer | Issue 8/2011

Abstract

Purpose

Slow accrual to cancer clinical trials impedes the progress of effective new cancer treatments. Poor physician–patient communication has been identified as a key contributor to low trial accrual. Question prompt lists (QPLs) have demonstrated a significant promise in facilitating communication in general, surgical, and palliative oncology settings. These simple patient interventions have not been tested in the oncology clinical trial setting. We aimed to develop a targeted QPL for clinical trials (QPL-CT).

Method

Lung, breast, and prostate cancer patients who either had (trial experienced) or had not (trial naive) participated in a clinical trial were invited to join focus groups to help develop and explore the acceptability of a QPL-CT. Focus groups were audio-recorded and transcribed. A research team, including a qualitative data expert, analyzed these data to explore patients' decision-making processes and views about the utility of the QPL-CT prompt to aid in trial decision making.

Results

Decision making was influenced by the outcome of patients' comparative assessment of perceived risks versus benefits of a trial, and the level of trust patients had in their doctors' recommendation about the trial. Severity of a patient's disease influenced trial decision making only for trial-naive patients.

Conclusion

Although patients were likely to prefer a paternalistic decision-making style, they expressed valuation of the QPL as an aid to decision making. QPL-CT utility extended beyond the actual consultation to include roles both before and after the clinical trial discussion.

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Kolata G (2009) Forty years' war: lack of study volunteers hobbles cancer fight, in New York Times. New York Times Co, New York

Ellis P et al (1996) Accrual to clinical trials in breast cancer. Annual Scientific Meeting of the Clinical Oncological Society of Australia. Brisbane, Australia

Avis NE et al (2006) Factors associated with participation in breast cancer clinical trials. J Clin Oncol 24(12):1860–1867PubMedCrossRef

Lara PN et al (2001) Prospective evaluation of clinical trial accrual patterns: identifying potential barriers to enrolment. J Clin Oncol 19:1728–1733PubMed

Robinson JM, Trochim WMK (2007) An examination of community members', researchers" and health professionals" perceptions of barriers to minority participation in medical research: an application of concept mapping. Ethn Health 12(5):521–539PubMedCrossRef

Lee JY, Breaux SR (1983) Accrual of radiotherapy patients to clinical trials. Cancer 52:1014–1016PubMedCrossRef

Martin JF, Henderson WG, Zacharski LG (1984) Accrual of patients into a multi hospital cancer clinical trial and its implications on planning future studies. Am J Clin Oncol 7:173–182PubMedCrossRef

Mills EJ et al (2006) Barriers to participation in clinical trials of cancer: a meta analysis and systematic review of patient-reported factors. Lancet Oncol 7(2):141–148PubMedCrossRef

Fallowfield L (1995) Can we improve the professional personal fulfilment of doctors in cancer medicine. Br J Cancer 71:1132–1133PubMedCrossRef

10.

Fallowfield L, Ratcliffe D, Souhami RL (1997) Clinicians' attitudes to clinical trials of cancer therapy. Eur J Cancer 33:2221–2229PubMedCrossRef

11.

Hall A (2001). The role of effective communication in obtaining informed consent in medical research. Loyal L, Tobias JS (Eds). BMJ Books, London. p. 290–298.

12.

Benson A, Pregle J, Bean J (1991) Oncologists reluctance to accrue patients onto clinical trials. J Clin Oncol 9:2067–2075PubMed

13.

Penman D, Holland J, Bahna G (1984) Informed consent for investigational chemotherapy; patients' and physicians' perceptions. J Clin Oncol 2:849–855PubMed

14.

Cahn CH (1980) Consent in psychiatry. The position of the Canadian Psychiatric Association. Can J Psychiatry 25:78–84PubMed

15.

Finklestein D, Karsh-Smith M, Faden R (1993) Informed consent in medical ethics. Arch Ophthalmol 111:324–326

16.

Kirby MD (1983) Informed consent: what does it mean. J Med Ethics 9:69–75PubMedCrossRef

17.

Lebacqz K, Levine RJ (1977) Respect for persons and informed consent to participate in cancer research. J Clin Res 25:101–107

18.

Grossman SA, Piantadosi S, Cohavey C (1994) Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 12:2211–2215PubMed

19.

Cassileth BR et al (1980) Information and participation preferences among cancer patients. Ann Intern Med 92:832–836PubMed

20.

Blanchard CG et al (1988) Information and decision making preferences of hospitalised cancer patients. Soc Sci Med 27(11):1139–1145PubMedCrossRef

21.

Whelan T, Mohide EA, Willan AR (1997) The supportive care needs of newly diagnosed cancer patients attending a regional cancer centre. Cancer 80:1518–1524PubMedCrossRef

22.

Jenkins V, Fallowfield L, Saul J (2001) Information needs of cancer patients: results from a large study in UK cancer centres. Br J Cancer 84:48–51PubMedCrossRef

23.

Fleissig A, Jenkins VA, Fallowfield L (2000) Results of an intervention study to improve communication about randomised clinical trials of cancer therapy. Eur J Cancer 37:322–331CrossRef

24.

Strull WM, Lo B, Charles G (1984) Do patients want to participate in medical decision making? J Am Med Assoc 252(21):2990–2994CrossRef

25.

Bilodeau BA, Degner LF (1996) Information needs, sources of information, and decisional roles in women with breast cancer. Oncol Nurs Forum 23(4):691–696PubMed

26.

Butow PN et al (2006) A randomized trial of a consultation skills training to improve communication about cancer treatment options and clinical trials: interim analysis using Australian and New Zealand data. Psycho-oncol 14(2):Supplement S38

27.

Brown RF et al (2004) Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials. Soc Sci Med 58:379–390PubMedCrossRef

28.

Brown RF et al (2004) Seeking informed consent to cancer clinical trials: describing current practice. Soc Sci Med 58(12):2445–2457PubMedCrossRef

29.

Brown RF et al (1999) Promoting patient participation in the cancer consultation; evaluation of a prompt sheet and coaching in question asking. Br J Cancer 80(1/2):242–248PubMedCrossRef

30.

Brown RF et al (2001) Promoting patient participation and shortening cancer consultations: a randomised trial. Br J Cancer 85:1273–1279PubMedCrossRef

31.

Butow PN et al (1994) Patient involvement in the cancer consultation: evaluation of a question prompt sheet. Ann Oncol 5:199–204PubMed

32.

Roter D (1977) Patient participation in the patient-provider interaction: the effects of patient question asking on the quality of interaction, satisfaction and compliance. Health Educ Monogr 5:281–315PubMed

33.

Clayton J et al (2003) Asking questions can help: development and preliminary evaluation of a question prompt list for palliative care patients. Br J Cancer 89:2069–2077PubMedCrossRef

34.

McJannett M et al (2003) Asking questions can help: development of a question prompt list for cancer patients seeing a surgeon. Eur J Cancer Prev 12:397–405PubMedCrossRef

35.

Morgan D (1988) Focus groups as qualitative research. Sage Publications, Thousand Oaks, CA

36.

Krueger R, Casey M (2000) Focus groups: a practical guide for applied research. Sage Publications, Thousand Oaks

37.

Bernard HR, Ryan GW (1998) Text analysis: qualitative and quantitative methods. In: Bernard HR (ed) Handbook of methods in cultural anthropology. Sage, Thousand Oaks: CA.

38.

Creswell J (1988) Qualitative inquiry and research design: choosing among five traditions. Sage Publications, Thousand Oaks, CA

39.

Miles MV, Huberman MA (1984) Qualitative data analysis: a sourcebook of new methods. Sage, London

40.

Lewis RB (1998) A comprehensive review of two leading qualitative data analysis packages. Cultural Anthropology Methods 10:41–47

41.

Morse JM et al (2002) Verification strategies for establishing reliability and validity in qualitative research. Int J Qual Stud Educ 1:1–19

42.

Flynn KE et al (2008) Decisional conflict among patients who accept or decline participation in phase I clinical trials. JERHRE 3(3):69–77PubMedCrossRef

43.

Stryker JE et al (2006) Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction and decisional regret. Patient Educ Couns 63:104–109PubMedCrossRef

44.

Cox AC, Fallowfield LJ, Jenkins VA (2006) Communication and the informed consent process in phase I trials: a review of the literature. Support Care Cancer 14:303–309PubMedCrossRef

45.

Eggly S et al (2008) Oncologists’ recommendations of clinical trial participation to patients. Patient Educ Couns 70(1):143–148PubMedCrossRef

46.

Charles C, Gafni A, Whelan T (1997) Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med 44(5):681–692PubMedCrossRef

47.

Evans RG (1984) Strained mercy: the economics of Canadian health care. Butterworths, Toronto

48.

Gattellari M, Butow PN, Tattersall MH (2001) Sharing decisions in cancer care. Soc Sci Med 52(12):1865–1878PubMedCrossRef

49.

Degner LF, Sloan JA (1992) Decision making during serious illness: what role do cancer patients really want to play? J Clin Epidemiol 45:941–950PubMedCrossRef

50.

Charles C, Gafni A, Wheelan T (1999) Decision making in the physician–patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 49:651–661PubMedCrossRef

51.

Kaplan SH et al (1996) Characteristics of physicians with participatory decision making styles. Ann Intern Med 124:497–504PubMed

Title: Enhancing decision making about participation in cancer clinical trials: development of a question prompt list
Authors: Richard F. Brown
Elyse Shuk
Natasha Leighl
Phyllis Butow
Jamie Ostroff
Shawna Edgerson
Martin Tattersall
Publication date: 01-08-2011
Publisher: Springer-Verlag
Published in: Supportive Care in Cancer / Issue 8/2011
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-010-0942-6

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Abstract

Purpose

Method

Results

Conclusion

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