A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers
YAD
1 other identifier
interventional
20
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Apr 2024
Typical duration for not_applicable cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedStudy Start
First participant enrolled
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 12, 2026
December 1, 2025
2.1 years
December 7, 2023
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
14 +/- 2 Weeks
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.
14 +/- 2 Weeks
Study Arms (1)
Young Adults Coping with Cancer Together Intervention
OTHERYoung adults with cancer and their partner-caregivers will attend dyadic virtual psychotherapy sessions lasting 45-60 minutes on a weekly basis for eight weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uncontrolled psychosis, active suicidal ideation, or cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Emerson Hospital/MGH Cancer Center
Concord, Massachusetts, 01742, United States
Mass General at North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Mass General at Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie M Jacobs, Ph.D.
Massachusetts General Hospital
- PRINCIPAL INVESTIGATOR
Giselle K Perez, Ph.D.
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Harvard Medical School Department of Psychiatry
Study Record Dates
First Submitted
December 7, 2023
First Posted
December 15, 2023
Study Start
April 19, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 12, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: jjacobs@mgh.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.