Menu
Recruiting NCT05904782

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

Observational Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Primary outcome measures

  • Quality of Life questionnaire (Qol) [Time frame: through completion of study; approximately 1 month]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • The University of Texas M. D. Anderson Cancer Center — Houston

Identifiers

NCT: NCT05904782 · 2022-0940 · NCI-2023-04226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗