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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05904782
Collaborator
(none)
150
Enrollment
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2027
    Anticipated Study Completion Date :
    Nov 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life questionnaire (Qol) [through completion of study; approximately 1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Juliet Kroll, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05904782
    Other Study ID Numbers:
    • 2022-0940
    • NCI-2023-04226
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 15, 2023