Training for family caregivers of advanced cancer patients
Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
This study is testing a training program for family caregivers of newly-diagnosed advanced cancer patients to see if it helps them support their loved ones in making better healthcare decisions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT04803604 on ClinicalTrials.gov |
What this trial studies
This randomized factorial trial aims to enhance the decision support skills of family caregivers for individuals with newly-diagnosed advanced cancer using a Multiphase Optimization Strategy (MOST). The study will involve 256 family caregivers who will be randomized to receive various components of a nurse coach-delivered training program based on established decision support frameworks. The training includes psychoeducation, communication training, and the use of decision guides, with follow-up support over 24 weeks. The goal is to prepare caregivers to effectively assist patients in making informed healthcare decisions.
Who should consider this trial
Good fit: Ideal candidates for this study are family caregivers aged 21 and older who assist patients with advanced-stage cancer in making medical decisions.
Not a fit: Patients who are not involved in decision-making processes or those without a supportive caregiver may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the decision-making capabilities of family caregivers, leading to better patient outcomes and reduced distress.
How similar studies have performed: Previous studies have shown promise in enhancing caregiver support through training, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
FAMILY CAREGIVERS Inclusion Criteria: 1. ≥21 years of age; 2. self-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"; 3. caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below); 4. caregivers will need to have an agreeable patient willing to participate in the study for data collection; and 5. English-speaking and able to complete baseline measures. Exclusion Criteria: 1) Self-reported mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse. PATIENTS Inclusion Criteria: 1. ≥21 years of age; 2. diagnosed 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: 1) 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.
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Peggy McKie, MPH
- Email: bellpm@uab.edu
- Phone: 205-996-0196
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.