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Trial Title:
The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
NCT ID:
NCT06242964
Condition:
Cancer
Social Functioning
Psychosocial Functioning
Coping Skills
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Promoting Resilience in Stress Management - Social Needs (PRISM-SN)
Description:
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.
Arm group label:
PRISM-SN Intervention
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
12 Years
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seattle Children's
Address:
City:
Seattle
Zip:
98105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaitlyn Fladeboe, PhD
Start date:
May 15, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Seattle Children's Hospital
Agency class:
Other
Collaborator:
Agency:
University of Pittsburgh Medical Center
Agency class:
Other
Source:
Seattle Children's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06242964
