Clinical trial NCT03668223: The PRISM Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer
Official title: The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Quality of Life
Anxiety
Depression
Hope
Coping Skills
Communication
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: Baylor College of Medicine
name: University of Pittsburgh Medical Center
name: Seattle Children's Hospital
name: National Cancer Institute (NCI)
First posted: 2018-09-12
Enrollment: 195
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Pediatric Quality of Life Cancer Module
timeFrame: 3-months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) Total Score
timeFrame: 3-months
measure: Snyder Hope Scale
timeFrame: 3-months
measure: Connor Davidson Resilience Scale
timeFrame: 3-months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Abby R Rosenberg, MD, MS, MA
role: PRINCIPAL_INVESTIGATOR
References: