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NCT05904782 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05904782
Other study ID # 2022-0940
Secondary ID NCI-2023-04226
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2024
Est. completion date November 1, 2027

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Juliet Kroll
Phone (346) 723-5858
Email jlkroll@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date November 1, 2027
Est. primary completion date November 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life questionnaire (Qol) through completion of study; approximately 1 month
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