Menu
Recruiting NCT06172907

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

No phase Interventional Cancer Survivorship Caregiver Burden Psychological Distress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Young Adults Coping with Cancer Together Intervention.
Who it may be relevant to
Registry conditions: Cancer, Survivorship, Caregiver Burden, Psychological Distress. Basic parameters: 25 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility of Intervention [Time frame: 14 +/- 2 Weeks]
  • Acceptability of Intervention [Time frame: 14 +/- 2 Weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 4 centers
  • Massachusetts General Hospital Cancer Center — Boston
  • Emerson Hospital/MGH Cancer Center — Concord
  • Mass General at North Shore Cancer Center — Danvers
  • Mass General at Newton Wellesley Hospital — Newton

Identifiers

NCT: NCT06172907 · 23-472

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗