Brief Positive Affect program for caregivers of people with advanced cancer
Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer
This project will try a short, five-session positive-affect program to help adults who care for someone with stage IV cancer reduce distress and improve wellbeing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05904782 on ClinicalTrials.gov |
What this trial studies
This observational project will adapt an existing Positive Affect Treatment (PAT) to the needs of family caregivers of people with stage IV solid tumors and create a brief five-session version (PAT-C). Researchers will conduct qualitative work to identify themes and necessary content for the caregiving context and then develop the manualized brief intervention. They will also collect measures of caregiver psychosocial distress and health in a supportive care clinic to characterize need and feasibility for future randomized trials. Findings will be used to refine intervention content, estimate appropriate dose, and plan future RCTs to test feasibility, efficacy, and mechanisms.
Who should consider this trial
Good fit: Adults (18+) who read and speak English, provide unpaid care and live with a person diagnosed with stage IV solid malignancy for more than six months, and who have phone or internet access are appropriate candidates.
Not a fit: Caregivers currently in ongoing psychotherapy or those who are cognitively impaired, pregnant, or active military personnel are excluded and may not be eligible or benefit from this program.
Why it matters
Potential benefit: If successful, PAT-C could give caregivers practical skills to increase positive emotions, reduce stress, and improve quality of life.
How similar studies have performed: Positive-affect interventions have shown promising effects on mood and coping in caregiving and medical populations, but a brief PAT specifically adapted for advanced-cancer caregivers is novel and has not yet been tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Juliet Kroll — M.D. Anderson Cancer Center
- Study coordinator: Juliet Kroll
- Email: jlkroll@mdanderson.org
- Phone: (346) 723-5858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.