The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

Not Applicable

Active, not recruiting

Conditions: Communication
Anxiety
Depression
Coping Skills
Cancer
Hope
Quality of Life

Interventions: Behavioral: Promoting Resilience in Stress Management (PRISM)

Registration Number: NCT03668223

Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary: Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer

Detailed Description: Among patients with cancer and their families, early integration of palliative care may improve quality of life. This is particularly important for Adolescents and Young Adults (AYAs) because their distinct developmental challenges related to identity, relationships, and vocation may add to the burden of cancer. Among AYAs with advanced cancer, most understand that they may die and report that discussing end-of-life preferences, goals, and fears would be helpful; however, only 53% engage in such conversations. While national guidelines call for integrated palliative care in AYA oncology, developmentally targeted, evidence-based interventions designed to meet psychosocial and communication needs are lacking.

A potential barrier to improving the experiences of AYAs with advanced cancer may be their limited opportunities to develop "resilience resources" such as stress-management, goal-setting, positive reframing, and meaning-making skills. These resources may mitigate negative outcomes, facilitate engagement in goals of care discussions, and improve quality of life. Furthermore, promoting these resources among AYAs may give them the tools to more successfully navigate the challenges of the cancer experience.

Our research program is built on the central hypothesis that promoting resilience resources will improve psychosocial well-being. Over a series of studies, we developed a conceptual framework of resilience in pediatric cancer, affirmed associations between resilience resources and outcomes, and developed a novel resilience resources intervention (Promoting Resilience in Stress Management, PRISM). PRISM is a manualized, skills-based training program comprised of four 30-60 minute, in-person, one-on-one sessions plus a facilitated parent/caregiver/spouse/significant other family-meeting.

We completed a pilot Randomized Controlled Trial (RCT) to test the efficacy of PRISM among 100 AYAs, 6-months following their diagnosis of new (n=73) or recurrent (n=27) cancer. Results suggest PRISM is feasible, highly acceptable, and associated with increased patient-reported resilience as well as key clinically significant patient-centered outcomes such as quality of life and psychological distress. Subgroup analyses comparing patients with advanced cancer to those with new cancer suggested differentially stronger positive effects in the advanced cancer group, raising a hypothesis to be tested in dedicated trials. However, qualitative feedback from patients with advanced cancer suggested refinements targeting hopes, worries, and contextual meaning-making might strengthen PRISM's usefulness.

The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs with Advanced Cancer. We will first adapt and iteratively test the existing PRISM based on established guidelines for intervention development. Then, we will conduct a multi-site randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer (PRISM-AC). Findings will inform the development of larger dissemination studies and standards of AYA end-of-life and palliative care. Ultimately, this research has the potential to reduce the burden of cancer in a highly vulnerable population.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 195

Inclusion Criteria

Age 12-24 years
Diagnosed with advanced cancer: progressive, recurrent, refractory disease or any diagnosis with estimated overall survival <50% at least 2 weeks prior to enrollment
Able to speak English
Able to read English or Spanish
Cognitively able to participate in interviews

Exclusion Criteria

Patient Refusal
Parent Refusal (if patient <18 years-old)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Promoting Resilience in Stress Management (PRISM)	Promoting Resilience in Stress Management (PRISM)	Resilience Skills Training

Primary Outcome Measures

Name	Time	Method
Pediatric Quality of Life Cancer Module	3-months	Pediatric Quality of Life (PedsQL) Cancer Module -This scale was designed to assess pediatric cancer-specific health related quality of life. This is a 27 item scale, with each item rated on a 5-point Likert scale where 0=never and 4=almost always. Higher scores represent better health-related quality of life. Scale range is 0-100.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS) Total Score	3-months	The Hospital Anxiety and Depression Scale total score is a 14 items scale on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression. The total score is the sum of all 14 items, ranging from 0-42. Higher scores indicate higher total anxiety/depression.
Snyder Hope Scale	3-months	Hope: The Snyder "Hope" Scale measures "the overall perception that one's goals can be met." The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns.
Connor Davidson Resilience Scale	3-months	Resilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. This is a 10-item scale ranging from 0-40 where higher scores reflect greater perceived resilience.

Trial Locations

Locations (5): Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Seattle Children's Hospital
🇺🇸
Seattle, Washington, United States
Texas Children's Hospital
🇺🇸
Houston, Texas, United States
Children's Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States