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

NCT ID: NCT05904782

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-29

Study Completion Date

2027-11-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliet Kroll

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Juliet Kroll

Role: CONTACT

(346) 723-5858

Facility Contacts

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Juliet Kroll, BA,PHD

Role: primary

346-723-5858

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2023-04226

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0940

Identifier Type: -

Identifier Source: org_study_id

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