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Clinical Trials/NCT06172907
NCT06172907
Recruiting
Not Applicable

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

Massachusetts General Hospital8 sites in 1 country20 target enrollmentApril 19, 2024

Overview

Phase
Not Applicable
Intervention
Young Adults Coping with Cancer Together Intervention
Conditions
Cancer
Sponsor
Massachusetts General Hospital
Enrollment
20
Locations
8
Primary Endpoint
Feasibility of Intervention
Status
Recruiting
Last Updated
3 months ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 19, 2024
End Date
December 1, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jamie Jacobs

Assistant Professor, Harvard Medical School Department of Psychiatry

Massachusetts General Hospital

Eligibility Criteria

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

Arms & Interventions

Young Adults Coping with Cancer Together Intervention

Young adults with cancer and their partner-caregivers will attend dyadic virtual psychotherapy sessions lasting 45-60 minutes on a weekly basis for eight weeks.

Intervention: Young Adults Coping with Cancer Together Intervention

Outcomes

Primary Outcomes

Feasibility of Intervention

Time Frame: 14 +/- 2 Weeks

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).

Acceptability of Intervention

Time Frame: 14 +/- 2 Weeks

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.

Study Sites (8)

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