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

Depression Clinical Trial

— PRISM-AC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03668223
• Other study ID #: 22-653
• Secondary ID: STUDY00001229R01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 194
• Est. completion date: October 31, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Cancer
• Communication
• Coping Skills
• Depression
• Hope
• Quality of Life

Intervention

Behavioral:
• Promoting Resilience in Stress Management (PRISM)
Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
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	Seattle Children's Hospital	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Baylor College of Medicine, Children's Hospital Los Angeles, National Cancer Institute (NCI), Seattle Children's Hospital, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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