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Trial Title:
Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients with Advanced Cancer
NCT ID:
NCT05904782
Condition:
Cancer
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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).
Criteria for eligibility:
Study pop:
MD Anderson Cancer Center
Sampling method:
Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
November 1, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05904782
http://www.mdanderson.org
