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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Quality of Life; Cancer; Anxiety; Communication; Coping Skills; Hope
• Intervention / Treatment: Behavioral: Promoting Resilience in Stress Management (PRISM)

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abby R Rosenberg, MD, MS, MA; Phone Number: 617-632-5286; Email: abbyr_rosenberg@dfci.harvard.edu
• Study Contact Backup: Name: Liam Comiskey, BA; Phone Number: 617-632-5286; Email: liam_comiskey@dfci.harvard.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 900278
      • Children's Hospital Los Angeles
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98145
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Promoting Resilience in Stress Management (PRISM); Resilience Skills Training	Behavioral: Promoting Resilience in Stress Management (PRISM); Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making
No Intervention: Usual Care; Standard psychosocial care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PedsQL Generic Core and Cancer-Specific Quality of Life scores	Health-Related Quality of Life: The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life of AYAs with cancer. Items are rated on a 5-point Likert scale and total scores transformed to a 0-100 scale with higher scores representing better HRQOL.	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS) score	The HADS assesses mixed affective symptoms in patients with serious illness. The scale consists of 7 questions for anxiety and 7 for depression. Each is scored from 0-3, for a total range of 0-21 points per subscale. "Caseness" of anxiety and depression is defined as ≥8 points, with sensitivity/specificity of 0.8/0.9 for anxiety and 0.8/0.8 for depression.	3-months
Memorial Symptom Assessment Scale score	Symptom Burden: The MSAS measures the presence, severity, frequency, and extent of bother from 32 symptoms Likert scales assess physical and psychological symptoms. Total- and sub-scores are calculated as an average and normalized to a scale of 0-100, with higher scores representing higher symptom burden.	3-months
Hope scale score	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.	3-months
Connor Davidson Resilience Scale	Resilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. Two items from the original 25-item CD-RISC were used to create a brief, 2-item scale (the CD-RISC2), namely items 1 ("Able to adapt to change") and 8 ("Tend to bounce back after illness or hardship"). Each item consists of a 5-point Likert scale (scored from zero to four). The 2-item scale has a total of 10 points, with higher scores reflecting greater perceived resilience.	3-months
Palliative Care Engagement	Data will be abstracted from the medical record to track Adolescent involvement in shared decision-making and goals of care, including number/frequency of document medical decisions, completion of advance care planning documents, and palliative care resource utilization	3-months.
Parent Anxiety (Generalized Anxiety Disorder, GAD-7, scores)	This 7-item survey is commonly used to identify cases of generalized anxiety disorder and to assess symptom severity. GAD-7 score range from 0 to 21, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe anxiety symptoms levels, respectively.	3-months
Parent Depression (Patient Health Questionnaire, PHQ-8, scores)	This 8-item survey is scored on a 4-point Likert scale and the sum (0- 27) indicates the degree of depression, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe depression.	3-months
Parent Health-Related Quality of Life (SF-36 scores)	The SF-36 incorporates 8 concepts: physical functioning, body pain, limitations due to physical health problems, role limitations due to personal or emotional problems as well as emotional well-being and social functioning, energy, fatigue and general health perceptions. Scores will be summed and normalized to a 100 point (0-100) scale, with higher scores indicating higher quality of life	3-months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); Baylor College of Medicine; Seattle Children's Hospital; Children's Hospital Los Angeles; University of Pittsburgh Medical Center
• Investigators: Principal Investigator: Abby R Rosenberg, MD, MS, MA, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): January 23, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22-653; STUDY00001229 (Other Identifier: Seattle Children's Hospital); R01CA222486 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No