Clinical trial · Interventional
Pilot Optimization Trial of Decision Partnering Intervention for Advanced Cancer Family Caregivers
An Optimization Trial to Prepare Advanced Cancer Caregivers for Decision Partnering Using the Multiphase Optimization Strategy (MOST)
- 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 study is to pilot test, for the first time, an optimization trial approach to develop and refine the decision partnering skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2 full factorial design, 40 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 Theory4: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); and 3) Ottawa Decision Guide training (yes vs. no).
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 Caregivers | — | 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 (8)
- type
- EXPERIMENTAL
- label
- Basic social support + communication + Ottawa guide
- description
- 3 in-person/telephone weekly sessions on providing decision social support, tips for good communication, and decision support tools
- interventionNames
- Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
- type
- EXPERIMENTAL
- label
- Basic social support + communication
- description
- 2 in-person/telephone weekly sessions on providing decision social support and tips for good communication
- interventionNames
- Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)
- type
- EXPERIMENTAL
- label
- Basic social support + Ottawa guide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
FAMILY CAREGIVERS Inclusion: 1. ≥18 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 only); 5. English-speaking and able to complete baseline measures; and 6. Stated willingness to comply with all study procedures and be available for the duration of the study. Exclusion: 1\) Self-reported active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse PATIENTS Inclusion: 1. ≥18 years of age; 2. Diagnosed within past 60-90 days of initial pre-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; 3. English-speaking and able to complete baseline measures; and 4. Stated willingness to comply with all study procedures and be available for the duration of the study. Exclusion: 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 (0)
Data not yet available