| Registry | NCT06646614 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, health services research |
| Enrollment | 60 (Actual) |
| Sponsor | VA Palo Alto Health Care System (Fed); collaborators: US Department of Veterans Affairs |
| Conditions | Cancer |
| Interventions | Group Advance Care Planning Education (Behavioral) |
| Dates | start 2025-07-15, primary completion 2026-07-16, completion 2027-12-01 (estimated), first posted 2024-10-17, last updated 2026-08-19 |
| Locations | 1 site in United States |
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The proposed research aims to engage participants in group educational sessions to facilitate learning of topics related to advanced care planning and to determine whether this approach is more effective than usual care alone.
The purpose of this study is to compare usual care against a group advanced care planning intervention comprised of two sessions led by trained community health workers or health educators from VA Palo Alto. A total of 60 participants will be randomly assigned to either usual care (n=30) or usual care + group advanced care planning intervention (n=30). Usual care includes written, mailed educational materials about advanced care planning that patients may review independently. Those in the group advanced care planning arm will receive usual care along with the written materials and will participate in two 60-90 minute educational sessions led by a community health worker that will either be conducted in person on-site or by VA-approved video conference or a hybrid model. Topics will include an introduction to advanced care planning, goals of care topics, advance directives, and physicians order of life sustaining treatment. Both usual care and the group advanced care planning arms will also participate in pre/post surveys and/or interviews.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Usual Care | No intervention | The patient will continue to receive as normal and usual care. The participant will also receive educational materials in writing regarding advance care planning mailed to their preferred mailing address. The participants will complete surveys and interviews at baseline at again at 2 months post-enrollment. | |
| Group Advance Care Planning | Experimental | Behavioral: Group Advance Care Planning Education | The participant will receive normal and usual care which also consists of educational materials in writing regarding advance care planning mailed to their preferred mailing address. They will also engage in 2 group educational sessions with 4-5 participants which will last 60-90 minutes regarding advance care planning. They participants will complete surveys and interviews at baseline and again at 2 months post-enrollment. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. All patients >18 years old with newly diagnosed cancer are eligible. 2. Patients must have the ability to understand and willingness to provide verbal consent 3. Participants must speak English Exclusion Criteria: 1. Inability to consent to the study 2. Plans to move within the area and leave the VA system within 4 months
| Facility | City | Country | Status |
|---|---|---|---|
| VA Palo Alto | Palo Alto, California | United States |