CancerYADNCT06172907
A Dyadic Intervention for Young Adult Patients With Cancer and Their Partner Caregivers
A study testing Young Adults Coping with Cancer Together Intervention in people with Cancer and Survivorship, run by Massachusetts General Hospital at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 39 years
- Conditions the study is for
- Cancer, Survivorship, Caregiver Burden
- What is being tested?
- Young Adults Coping with Cancer Together Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Apr 2024to 19 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled psychosis, active suicidal ideation, or cognitive impairment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Emerson Hospital/MGH Cancer Center
Concord, Massachusetts, 01742
Mass General at North Shore Cancer Center
Danvers, Massachusetts, 01923
Mass General at Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
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.
Read the 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.
- Conditions
- Cancer, Survivorship, Caregiver Burden, Psychological Distress, Coping Skills, Couples
- Being tested
- Young Adults Coping with Cancer Together Intervention
- Keywords
- Young Adult Cancer, Cancer Caregiving
- Medical subject headings
- Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Adults Coping with Cancer Together InterventionBehavioural
Also called YAD 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.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults Coping with Cancer Together Intervention | Other | 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. Receives: Behavioral: Young Adults Coping with Cancer Together Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention
Feasibility will be measured by participant rates of enrollment (≥50% of eligible participants enroll), participant retention (≥70% complete the 14-week post-baseline assessment), and intervention attendance (≥70% of participants attending at least 6 of 8 sessions).
Measured: 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.
Measured: 14 +/- 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start19 Apr 2024
- Primary completion19 Apr 2026
- Study completion19 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-Arm Pilot Study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Jacobs, Massachusetts General Hospital
- Investigators
- Jamie M Jacobs, Ph.D., Principal investigator, Massachusetts General HospitalGiselle K Perez, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172907
- Sponsor's protocol ID
- 23-472
- Acronym
- YAD
- Status last verified
- Jul 2026
- First submitted
- 7 Dec 2023
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.