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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242964
• Other study ID #: STUDY00004509
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Seattle Children's Hospital
• Contact: Kaitlyn M Fladeboe, PhD
• Phone: 2068844140
• Email: katy.fladeboe[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Coping Skills
• Psychosocial Functioning
• Social Functioning

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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