The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer

The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial

The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to:

1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback.
2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care.

Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Coping Skills; Psychosocial Functioning; Social Functioning
• Intervention / Treatment: Behavioral: Promoting Resilience in Stress Management - Social Needs (PRISM-SN)

Detailed Description

In this randomized controlled trial, AYAs newly diagnosed with cancer will be recruited from two sites and randomly assigned to receive usual care alone or usual care with the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted program. PRISM-SN is a skill-based behavioral program that includes 4 core modules plus a newly developed social health module. Participants on both arms with complete a standardized patient-reported outcome survey assessing aspects of social and psychological functioning at enrollment and 12-week follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaitlyn M Fladeboe, PhD; Phone Number: 2068844140; Email: katy.fladeboe@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's
      • Contact: Kaitlyn Fladeboe, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 12-25 years
• Diagnosed with new malignancy treated with chemotherapy and/or radiation <6-months
• Able to speak in the English language
• Able to read in the English language
• Cognitively able to participate in intervention sessions and complete surveys

Exclusion Criteria:

• Aged <12 or >25 years
• Diagnosed with recurrent malignancy
• Diagnosed with new malignancy >6 months
• Not receiving chemotherapy and/or radiation
• Not able to speak in the English language
• Not able to read in the English language
• Not cognitively able to participate in intervention session or complete surveys

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Standard psychosocial care
Experimental: PRISM-SN Intervention; Skill-based psychosocial program	Behavioral: Promoting Resilience in Stress Management - Social Needs (PRISM-SN); The Promoting Resilience in Stress Management - Social Needs (PRISM-SN) intervention is a brief, skill-based psychosocial program. Five core sessions are delivered one-on-one, 1-2 weeks apart, in-person or via videoconference. Sessions teach evidence-based behavioral skills for managing stress, setting goals, reframing negative thoughts, meaning-making, and connecting with others. Each session lasts <60 minutes and is supported by paper-and-pencil or mobile app-based worksheet(s) for learning and practice. A final review session may be completed individually or with a family member, caregiver, or significant other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure	The Cancer Behavior Inventory - Social Relationship Coping Efficacy measure assesses one's confidence to engage in behaviors that maintain or enhance close social relationships in the context of illness. Ten items are rated 1-10; items are summed, with higher scores reflecting higher social relationship coping efficacy.	12-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multidimensional Scale of Perceived Social Support (MSPSS)	The Multidimensional Scale of Perceived Social Support (MSPSS) is a brief tool designed to measure support from family, friends, and a significant other. It includes 12 items with 4 per subscale. Items are rated on a 7-point Likert scale from 1 (very strongly disagree) to 7 (very strongly agree). It has been validated in both adolescents and adults. Mean scale scores ranging from 1-2.9 can be considered low support; 3-5 considered moderate support; and 5.1-7 considered high support.	12-weeks
Snyder Hope Scale	The Snyder Hope Scale contains 8 hope items plus 4 filler questions, and measures the overall perception that one's goals can be met. Each item is scored on an 8-point Likert scale; higher scores imply greater levels of hopeful thought patterns.	12-weeks
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale	The Pediatric Profile-25 (v2.0) includes 25 items assessing health status across 7 domains: physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference, and pain intensity. For this study, we will also include the 4-items pediatric family relationships short-form subscale (v1.0). All items are scored on a 5-point Likert scale except for a single pain intensity item scored on a 10-point scale; higher scores indicate more of each domain. Total raw scores are converted to standardized T-scores with a population mean of 50 and a standard deviation of 10.	12-weeks
Connor-Davidson Resilience Scale (CS-RISC)	The Connor-Davidson Resilience Scale (CS-RISC) is a reliable and widely used instrument assessing self-perceived resilience. Scores range from 0-40, with higher scores indicating higher self-perceived resilience.	12-weeks
Hospital Anxiety and Depression Scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) assesses mixed affective symptoms in patients with serious illness. The scale includes 7 questions for anxiety and 7 for depression. Each is scored from 0-3 for a total range of 0-21 for each subscale. Clinically relevant symptoms are defined as scores of 8 or higher for both anxiety and depression.	12-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	The Acceptability of Intervention Measure (AIM) assess perceived intervention acceptability. It includes 4-items such as "[program] meets my approval," scored 1-5, with higher scores reflecting more acceptability. Scores are averaged across items. This measure will be completed by experimental arm participants only.	12-weeks

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: University of Pittsburgh Medical Center
• Investigators: Principal Investigator: Kaitlyn M Fladeboe, PhD, Seattle Children's

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant data may be shared upon request. Investigators interested in conducting additional analyses must request data directly from the PI via written correspondence and obtain and provide verification of institutional review board approval.
• IPD Sharing Time Frame: Data can be shared after publication of study findings; coded banked data will be available indefinitely.
• IPD Sharing Access Criteria: Written request to the PI.
• 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