An intelligent search tool for clinical trials

Sign In
Back|NCT04803604Recruiting
Official Title

Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial

Sponsor
University of Alabama at Birmingham
Enrollment
256
Timeline
Jan 2022 → Jun 2026
About This Study

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this randomized factorial trial is to identify components of a intervention (CASCADE) to enhance the decision support skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2x2 full factorial design, 256 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); 3) Ottawa Decision Guide training (yes vs. no); and monthly follow (1 monthly follow-up call vs. monthly follow-up calls for 24 weeks).

Eligibility Criteria

Inclusion Criteria

  • 1≥21 years of age;
  • 2self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help";
  • 3caregivers will need to have an agreeable patient willing to participate in the study for data collection; and
  • 4English-speaking and able to complete baseline measures.
  • 5≥21 years of age;
  • 6diagnosed within 60 days of initial screening with an advanced cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma, and hematologic malignancies.

Exclusion Criteria

  • 11\) Self-reported mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.
  • 2PATIENTS
  • 31\) Medical record documentation of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.

Locations

2 sites participating in this study

Emory University

Atlanta, Georgia 30303

Recruiting

Dio Kavalieratos, PhD

University of Alabama at Birmingham

Birmingham, Alabama 35294

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →