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


METHODS
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.


CONCLUSIONS
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.
Brown
Richard F
RF
Department of Social and Behavioral Health, Virginia Commonwealth University School of Medicine, 1112 East Clay St, Richmond, VA, 23298-0149, USA. rbrown39@vcu.edu
Shuk
Elyse
E
Leighl
Natasha
N
Butow
Phyllis
P
Ostroff
Jamie
J
Edgerson
Shawna
S
Tattersall
Martin
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D003142:Communication; D003657:Decision Making; D005260:Female; D017144:Focus Groups; D006801:Humans; D007258:Informed Consent; D008297:Male; D008495:Medical Oncology / Q000379:methods; D008875:Middle Aged; D009369:Neoplasms; D010353:Patient Education as Topic; D010358:Patient Participation; D010817:Physician-Patient Relations; D036301:Qualitative Research; D012720:Severity of Illness Index; D013637:Tape Recording; D035502:Trust