Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care

Abstract

Objective Adolescents and young adults (AYAs) with cancer are at high risk of negative psychosocial outcomes. Promoting Resilience in Stress Management (PRISM), a novel, brief, skill‐based intervention, has demonstrated efficacy in improving psychosocial well‐being for AYAs. We utilized data from a recent randomized trial of PRISM versus usual care (UC) to categorize and explore group differences in change trajectories of patient reported outcomes (PROs) over time. Methods One hundred English‐speaking AYAs (aged 12‐25 years old) with cancer were randomized to PRISM versus UC. At enrollment and 6 months later, AYAs completed validated PROs measuring resilience (Connor‐Davidson Resilience Scale [CDRISC‐10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer‐specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler‐6). Patient response trajectories were categorized as “improved,” “consistently well,” “consistently at risk,” or “deteriorated” using minimal clinically important differences (MCIDs) or established measure cutoffs for all PROs. Positive response trajectories consisted of the first two categories (“improved” and “consistently well”), and negative response trajectories consisted of the latter two categories (“consistently at risk” and “deteriorated”). Results Across all PROs, more patients in the PRISM arm “improved” in psychosocial well‐being over time, and fewer PRISM recipients “deteriorated” over time. Across all PROs, a greater proportion of PRISM participants (vs UC) experienced positive response trajectories. Across all PROs, a greater proportion of UC participants experienced negative response trajectories. Conclusions PRISM shows evidence of both a prevention effect and an intervention effect. Thus, PRISM may serve as a viable prevention and early intervention model for psychosocial care.

Conducting Psychosocial Intervention Research among Adolescents and Young Adults with Cancer: Lessons from the PRISM Randomized Clinical Trial

“…Secondary objectives included examining PRISM’s effect on AYA patient-reported quality of life, hope, benefit finding, distress, anxiety, and depression. Results have been reported elsewhere; briefly, PRISM was associated with improvements in all outcomes of interest [26,27,28]. The present report describes our team’s experience and lessons learned during the conduct of this RCT.…”

“…AYA participation in clinical trials is limited, especially when the trial involves a psychosocial intervention [11]. We aimed to share our experiences and lessons learned in the successful conduct of the PRISM randomized trial [26,27,28], We found that investing in staff and engaging AYAs were key. Staff investment included full-time personnel devoted to the project, extensive training in pre-enrollment procedures such as describing the study, and ongoing support to help staff navigate the medical system.…”

“…We recently conducted and reported the results of a successful randomized clinical trial (RCT) testing the impact of a novel psychosocial intervention among AYAs who had recently received a diagnosis of new or recurrent cancer [26,27,28]. Briefly, we enrolled and randomly assigned n = 92 AYAs with new or recurrent cancer to receive usual psychosocial care with or without the Promoting Resilience in Stress Management (PRISM) intervention.…”

“…Briefly, we enrolled and randomly assigned n = 92 AYAs with new or recurrent cancer to receive usual psychosocial care with or without the Promoting Resilience in Stress Management (PRISM) intervention. We found that AYAs who received PRISM reported higher resilience, hope, benefit finding, and cancer-related quality of life, and lower psychological distress 6 months after enrollment [26,27,28]. The purpose of the present report is to provide detailed descriptions of our study procedures and the lessons we learned during the conduct of this trial.…”

Feasibility and acceptability of the “Day 100 Talk”: An interdisciplinary communication intervention during the first six months of childhood cancer treatment

“…Scores ≥13 indicate potential serious mental illness 37 . Previous studies have proposed score cutoffs of <6, 54 <7, 55 and <8 56 to distinguish adults and/or parents with low psychological distress. A prior study found that, for parents of children with advanced cancer, the mean Kessler 6 score was 7.9 with a standard deviation of 4.4 38 .…”