Group Advanced Care Planning Pilot for Veterans

NCT06646614 | Recruiting

• 1 other identifier: 67728
• Study Type: interventional
• Target: 50
• 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.

  Week 8 after patient enrollment

Secondary Outcomes (6)

• Feeling Heard and Understood

  Baseline and Week 8 after patient enrollment

• Change in patient activation using the Patient Activation Measure

  Baseline and Week 8 after patient enrollment

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

  Baseline and Week 8 after patient enrollment

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

  At Baseline, 8 weeks and 6 months after patient enrollment

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

  At Baseline, 8 weeks and 6 months 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 8 weeks post enrollment.

Group Advance Care Planning

EXPERIMENTAL

The participant will engage in 2 hours of educational sessions regarding advance care planning and goals of care. They will be interviewed which is expected to last 20-30 min and surveys will last 15-20 min. The total involvement will be no more than 3 hours and 40 min over 8 weeks.

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 sessions for a total of 2 hours 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 8 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

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Manali I Patel, MD MPH MS

CONTACT

6504935000; manalip@stanford.edu

Madhuri Agrawal

CONTACT

650-304-7744; madhuri.agrawal@va.gov

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 (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)