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Clinical Trials/NCT03668223
NCT03668223
Completed
Not Applicable

The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

Dana-Farber Cancer Institute5 sites in 1 country195 target enrollmentApril 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Dana-Farber Cancer Institute
Enrollment
195
Locations
5
Primary Endpoint
Pediatric Quality of Life Cancer Module
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2019
End Date
October 31, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abby Rosenberg

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Pediatric Quality of Life Cancer Module

Time Frame: 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 Outcomes

  • Hospital Anxiety and Depression Scale (HADS) Total Score(3-months)
  • Snyder Hope Scale(3-months)
  • Connor Davidson Resilience Scale(3-months)

Study Sites (5)

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