Clinical Trial Details
Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
Overview
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
| Ages | 21 Years and older |
| Sex | All |
| Healthy Volunteers | Yes |
| Age Groups | Adult, Older Adult |
FAMILY CAREGIVERS
Inclusion Criteria:
- ≥21 years of age;
- 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";
- caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below);
- caregivers will need to have an agreeable patient willing to participate in the study for data collection; and
- 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:
- ≥21 years of age;
- 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.