A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

Cancer Clinical Trial

— YAD  

Official title:

A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172907
• Other study ID #: 23-472
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Jamie M Jacobs, Ph.D.
• Phone: 617-643-1777
• Email: jjacobs[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to examine the feasibility and acceptability of a brief psychotherapy intervention to improve psychosocial coping and maintain couple relationships among young adults (aged 25-39) with cancer and their caregiving partners.

Description:

Young adults (YA) with cancer have unique challenges in coping, and their primary partners may experience burden and low self-efficacy related to caregiving. In this single-arm pilot trial, the investigators shall deliver an eight-session intervention to YAs with cancer and their self-identified partners who provide caregiving. The intervention is founded on principles from cognitive-behavioral therapy and couples-focused interventions, tailored for YA. The aim of the study is to assess the feasibility and acceptability of the intervention, which will inform refinements prior to a larger-scale clinical trial. This study will include 10 YAs and their partner-caregivers (N=20). Participants will complete surveys at baseline and after the intervention, and will be invited to complete optional semi-structured exit interviews.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 39 Years

Eligibility

Inclusion Criteria:

• Either: (1) Currently receiving active cancer treatment (n=5) or are within two years of completing active treatment (n=5) at Massachusetts General Cancer Center (MGHCC), located in Boston, Massachusetts, United States, OR (2) are the partner of an individual between the ages of 25-39 who is currently receiving treatment at MGHCC (n=5) or who has completed cancer treatment at MGHCC within the past two years (n=5)

• Either: (1) Indicates a score =4 on the National Comprehensive Cancer Network (NCCN) adapted distress thermometer study screening questions, OR (2) are the partner of a participant indicating a score =4 on the NCCN adapted distress thermometer study screening questions

• English-speaking

Exclusion Criteria:

• Uncontrolled psychosis, active suicidal ideation, or cognitive impairment

Related Conditions & MeSH terms

• Cancer
• Caregiver Burden
• Coping Skills
• Couples
• Psychological Distress
• Survivorship

Intervention

Behavioral:
• Young Adults Coping with Cancer Together Intervention
This intervention is based on cognitive-behavioral therapy and couples' therapy. It aims to improve cancer and caregiving-related self-efficacy and coping, as well as promote relationship maintenance in context of cancer. The intervention will be delivered by a trained mental health practitioner and include didactics, experiential exercises, and home practice.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Emerson Hospital/MGH Cancer Center	Concord	Massachusetts
United States	Mass General at North Shore Cancer Center	Danvers	Massachusetts
United States	Mass General at Newton Wellesley Hospital	Newton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention	Feasibility will be measured by measured by participant rates of enrollment (=50% of those eligible), participant retention (=70% of those enrolled), and intervention attendance (=70% attending at least 6 of 8 sessions).	10 +/- 2 Weeks
Primary	Acceptability of Intervention	Acceptability with be measured by satisfaction with the intervention as rated on the Client Satisfaction Questionnaire. The intervention will be deemed acceptable if =75% of participants report average satisfaction that exceeds the CSQ's midpoint.	10 +/- 2 Weeks