Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT05904782
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

To learn more about the experience and wellbeing of people who provide care for cancer patients.

Detailed Description

OBJECTIVES

Primary Objectives:

The primary objective of this proposal is to identify relevant themes and content essential to adapt PAT to a caregiving in advanced cancer context (PAT-C) and develop a Brief (5-session) version of PAT-C. Findings from this study are essential to inform future RCTs to test the feasibility, efficacy, dose and explore potential mediators of treatment outcomes of this intervention.

Secondary Objectives:

The secondary objective is to characterize psychosocial distress and psychosocial health of caregivers in the supportive care clinic. This data will be essential to inform appropriateness of the supportive care clinic as a potential site for future RCTs (i.e., determine if there are enough caregivers in this clinic who might benefit from this specific supportive care strategy).

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Start: 2025-11-01
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Males and female adults ≥18 years
• Able to read and speak English
• Caregiver of a patient diagnosed with stage IV solid malignancy, with whom they have been residing for >6 months
• Access to necessary resources for participating in a technology-based intervention (i.e., telephone, internet access)

Exclusion Criteria

• Current participation in consistent (self-defined) psychotherapy
• Caregivers who are considered part of a vulnerable population (i.e. cognitively impaired (self-reported or patient-reported), pregnant, military personnel) will not be eligible.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life questionnaire (Qol)	through completion of study; approximately 1 month