Clinical trial NCT06172907: A Dyadic Intervention for Young Adult Patients with Cancer and Their Partner Caregivers
Official title: A Dyadic Intervention for Young Adult Patients with Cancer and Their Partner Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Survivorship
Caregiver Burden
Psychological Distress
Coping Skills
Couples
Keywords: Young Adult Cancer
Cancer Caregiving
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Arm Pilot Study
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: 10 +/- 2 Weeks
measure: Acceptability of Intervention
timeFrame: 10 +/- 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Concord
country: United States
facility: Emerson Hospital/MGH Cancer Center
state: Massachusetts
city: Danvers
country: United States
facility: Mass General at North Shore Cancer Center
state: Massachusetts
city: Newton
country: United States
facility: Mass General at Newton Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jamie M Jacobs, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Giselle K Perez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: