Clinical trial · Interventional
Decision Support Training for Advanced Cancer Family Caregivers: The CASCADE Factorial Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Family Members | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CASCADE (CAre Supporters Coached to be Adept DEcision partners) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (16)
- type
- EXPERIMENTAL
- label
- Basic social support + communication + Ottawa guide + 1 monthly follow up call
- description
- 3 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and a single monthly follow-up call
- interventionNames
- Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
- type
- EXPERIMENTAL
- label
- Basic social support + communication + Ottawa guide + monthly follow up calls for 24 weeks
- description
- 3 in-person/telephone weekly sessions on providing social support, tips for good communication, decision support tools, and monthly follow-up calls for 6 months
- interventionNames
- Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGazaway S, Wells RD, Azuero A, Pisu M, Guastaferro K, Rini C, Taylor R, Reed RD, Harrell ER, Bechthold AC, Bratches RW, McKie P, Lowers J, Williams GR, Rosenberg AR, Bakitas MA, Kavalieratos D, Dionne-Odom JN. Decision support training for advanced cancer family caregivers: Study protocol for the CASCADE factorial trial. Contemp Clin Trials. 2023 Aug;131:107259. doi: 10.1016/j.cct.2023.107259. Epub 2023 Jun 5. PMID 37286131