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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Juliet Kroll; Phone Number: (346) 723-5858; Email: jlkroll@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas M. D. Anderson Cancer Center
      • Contact: Juliet Kroll, BA,PHD; Phone Number: 346-723-5858; Email: jlkroll@mdanderson.org
      • Principal Investigator: Juliet Kroll, BA, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

MD Anderson Cancer Center

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of Life questionnaire (Qol)	through completion of study; approximately 1 month

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Juliet Kroll, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2022-0940; NCI-2023-04226 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No