Group Advanced Care Planning Pilot for Veterans

NCT06646614 | Active Not Recruiting

• 1 other identifier: 67728
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Goals of Care Documentation

  Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.

  Month 2 after patient enrollment

Secondary Outcomes (6)

• Feeling Heard and Understood

  Baseline and Month 2 after patient enrollment

• Change in patient activation using the Patient Activation Measure

  Baseline and Month 2 after patient enrollment

• Change in patient satisfaction with decision using the Satisfaction with Decision Measure

  Baseline and Month 2 after patient enrollment

• Palliative Care Use (Self-reported and Chart Review)

  At Baseline and Month 6 after patient enrollment

• Hospice Care Use (Self-reported and Chart Review)

  At Baseline and Month 6 after patient enrollment

Study Arms (2)

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

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.

Behavioral: Group Advance Care Planning Education

Interventions

Group Advance Care Planning Education BEHAVIORAL

Those assigned to the group ACP arm will receive usual care and the intervention which consists of 2 virtual or in-person 60-90 minute sessions by a trained community health worker/health educator. Sessions will introduce advanced care planning, help veterans discuss their goals of care with their care teams and learn how to discuss with their families and oncologist, and filing an advanced directive. Participants will be surveyed and interviewed at baseline and again at 2 months post-enrollment.

Group Advance Care Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \>18 years old with newly diagnosed cancer are eligible.
• Patients must have the ability to understand and willingness to provide verbal consent
• Participants must speak English

You may not qualify if:

• Inability to consent to the study
• Plans to move within the area and leave the VA system within 4 months

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Palo Alto

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician analyzing the data will be masked from the experimental treatment and the control as will all research staff who are abstracting or collecting outcomes data.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: July 15, 2025
• Primary Completion: July 16, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)