The Experience of Older Patients With Cancer in Phase 1 Clinical Trials: A Qualitative Case Series

Abstract

This article explores the experiences of older patients with cancer in phase 1 clinical trials. Conducting a case series of face-to-face, in-depth, open-ended interviews and using qualitative methods of analysis, we find that the psychosocial process of social comparison is relevant for understanding older adults' phase 1 clinical trial participation. Social comparison influences decisions to enroll in a phase 1 clinical trial, shapes perceptions of supportive care needs, and encourages the utilization of hope. Additional research should develop strategies for addressing supportive care needs among this patient cohort whose use of social comparison can inhibit articulation of pain, suffering, and symptom burden as well as use of informal support systems.

What matters in clinical trial decision‐making: a systematic review of interviews exploring cancer patients’ experiences

“…Wanting a cure. In general, wanting a cure was the primary motivation of patients to participate in a clinical trial (32,37,39,42). Several patients were willing to try anything that was suggested to them (40)(41)(42), and even though the treatment had proved ineffective on previous occasions, they were willing to try it again (38).…”

Patient information in phase 1 trials: A systematic review

“…In 3 cross‐sectional studies and 1 qualitative study, most of the patients decided to participate independently of the influence of others; however, 1 qualitative study determined that the family's attitude was important . Comparing their own situation with that of others influenced the decision to participate in a qualitative study of older patients . Patients participating in a trial were less conflicted about the decision than those who rejected trial as described in a cross‐sectional study .…”

“…37 Comparing their own situation with that of others influenced the decision to participate in a qualitative study of older patients. 38 Patients participating in a trial were less conflicted about the decision than those who rejected trial as described in a cross-sectional study. 36 A cross-sectional study showed that poorer overall health was related to greater willingness to enter a phase 1 trial.…”

“…Evaluation of the qualitative studies was conducted by one author who is particularly experienced in this field (M.T.H.). FIGURE 1 "Preferred reporting items for systematic reviews and meta-analyses" flow diagram for the screening and selection of studies 3 | RESULTS Thirty-seven studies met the inclusion criteria; 15 studies addressed important factors in deciding to participate in a phase 1 trial, [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39] 30 studies explored patients' perception of the information they received, [25][26][27]31,[33][34][35][36]40-61 and 1 study examined relatives' perceptions of the information. 44 Eight studies met the inclusion criteria for both decision making and patients' perceptions of information, [25][26][27]31,[33][34][35][36] and 1 study met the inclusion criteria for both patients' and relatives' perception of the information.…”

“…In all studies, patients had cancers at various sites. Seven studies 28,29,37,38,43,47,58 were qualitative, 4 studies 35,51,52,57 involved randomization to an educational intervention or certain wording of questions, 4 studies 39,40,60,61 collected data on a cohort more than once, and 22 studies were of cross-sectional design. [25][26][27][30][31][32][33][34]36,41,42,[44][45][46][48][49][50][53][54][55][56]59 Six of the quantitative studies included a descriptive analysis 26,30,40,41,59,60 ; the remaining quantitative studies included statistical analyses and tests of significance, 25,27,[31][32][33]…”