Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Uncontrolled psychosis, active suicidal ideation, or cognitive impairment
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie M Jacobs, Ph.D. | Contact | 617-643-1777 | jjacobs@mgh.harvard.edu | |
| Zeba N Ahmad, Ph.D. | Contact | 617-724-1586 | zahmad2@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jamie M Jacobs, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Giselle K Perez, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Recruiting | Boston | Massachusetts | 02114 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 11, 2026 | |
| Reset | Jul 7, 2026 |
Not provided
Single-Arm Pilot Study
Not provided
Not provided
Not provided
Not provided
|
|
| Emerson Hospital/MGH Cancer Center | Recruiting | Concord | Massachusetts | 01742 | United States |
|
| Mass General at North Shore Cancer Center | Recruiting | Danvers | Massachusetts | 01923 | United States |
|
| Mass General at Newton Wellesley Hospital | Recruiting | Newton | Massachusetts | 02462 | United States |
|
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 11, 2026 | Jul 7, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided