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NCT Number: NCT06172907

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

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.

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Key information

Age range

25 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Young Adults Coping with Cancer Together Intervention

Behavioral

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.

Other names: YAD Intervention

Primary outcomes

  1. 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).

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Jamie M Jacobs, Ph.D.

CONTACT

[email protected]

617-643-1777

Zeba N Ahmad, Ph.D.

CONTACT

[email protected]

617-724-1586

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: YAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2023
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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