Adapting Psychosocial Resiliency Intervention for Parents of Adolescents and Young Adults With Cancer

NCT07139769 | Recruiting

• 2 other identifiers: 25-242IRG-21-130-10-IRG-11
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The study team aims to adapt a psychosocial intervention to reduce psychological distress among the caregiving parents of adolescents and young adults (aged 15-39) who have cancer. First, the study team will adapt an evidence-supported, group-based program for improving psychological resiliency (Stress Management and Resiliency Training - Relaxation Response Resiliency Program; SMART-3RP(E. R. Park et al., 2021)), and iteratively incorporate feedback from parents of AYA with cancer using a mixed-methods approach. Next, the study team will pilot the refined intervention to assess for preliminary indicators of feasibility, acceptability, and potential for efficacy in reducing parental distress.

Conditions

Caregiving for Cancer

Keywords

adolescents and young adults with cancer; cancer caregivers

Outcome Measures

Primary Outcomes (3)

• Intervention Feasibility: Percent of Identified Prospective Participants Who Enroll

  Percent of eligible participants who were offered participation and who enroll in the study by completing consent and baseline assessment.

  Post-treatment completion (enrollment to treatment completion is approximately 3 months)

• Intervention Feasibility: Proportion of Participants Completing the Program

  Percent of enrolled participants who complete the program, defined as completing 6 out of 8 sessions.

  Post-treatment completion (enrollment to treatment completion is approximately 3 months)

• Intervention Acceptability

  Acceptability will be assessed by the Client Satisfaction Questionnaire (CSQ-8). The intervention study will be considered acceptable if ≥80% of participants rate it as acceptable (defined as a CSQ-8 score ≥20).

  Post-treatment completion (enrollment to treatment completion is approximately 3 months)

Study Arms (1)

Psychosocial Intervention for Parental Caregivers of AYA with Cancer

EXPERIMENTAL

The study team aims to evaluate the feasibility and acceptability of the adapted psychosocial intervention to 1) improve psychological resiliency to stress and 2) reduce symptoms of depression, anxiety, and post-traumatic stress among parental caregivers, through a single-arm open pilot trial of 32 parents.

Behavioral: Psychosocial Intervention for Parental Caregivers of AYA with Cancer

Interventions

Psychosocial Intervention for Parental Caregivers of AYA with Cancer BEHAVIORAL

A new adaptation of an evidence-supported intervention, the SMART-3RP program, to address psychological symptoms and promote well-being among parental caregivers of AYA with cancer.

Psychosocial Intervention for Parental Caregivers of AYA with Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identifying parent/guardian who provides a primary informal caregiving role in their child's cancer
• Recipient of caregiving is aged between 15 and 39 years and is receiving treatment for cancer
• Participant must score equal to or greater than 2 (out of a possible 10) on the National Comprehensive Cancer Network Distress Thermometer
• English-speaking
• Aged over 18 years

You may not qualify if:

• Having a co-parent or other household member participating in the same study
• Active symptoms of psychosis or suicidal ideation that would preclude safe participation

Sponsors & Collaborators

• American Cancer Society, Inc.: collaborator
• Zeba Ahmad, Ph.D.: lead

Study Sites (1)

Mass General Brigham Cancer Institute at Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Zeba N Ahmad, Ph.D.

CONTACT

16177241586; zahmad2@mgh.harvard.edu

Xinghan Zhu, B.S.

CONTACT

6177247593; xzhu@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Staff Psychologist

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: October 22, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)