Clinical trial NCT06646614: Group Advanced Care Planning Pilot for Veterans
Official title: Group Advanced Care Planning Pilot for Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2024-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: explain random and two groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed research aims to engage participants with an advanced stage cancer diagnosis in group educational sessions to facilitate learning of topics related to advanced care planning. The investigators also hope to learn if conducting educational sessions in a group setting helps to create a more supportive environment amongst patients, caregivers, etc.

Detailed description: 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 50 participants will be randomly assigned to either usual care (n=25) or usual care + group advanced care planning intervention (n=25). Those in usual care will be mailed some educational materials about advanced care planning that they may review independently. Those in the group advanced care planning arm will participate in two 1-hour educational sessions led by the community health worker/educator that will be on site, 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.

Eligibility criteria: Inclusion Criteria:

1. All patients \>18 years old with newly diagnosed advanced 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 change oncologist within 4 months
3. Employed by the practice site
4. Patients who anticipate moving from the area within 4 months

Primary outcomes:
measure: Goals of Care Documentation
timeFrame: Baseline and Week 8 after patient enrollment
Secondary outcomes:
measure: Change in patient activation using the Patient Activation Measure
timeFrame: Baseline and Week 8 after patient enrollment
measure: Palliative Care Use (Self-reported and Chart Review)
timeFrame: Week 8 after patient enrollment
measure: Hospice Care Use (Self-reported and Chart Review)
timeFrame: Week 8 after patient enrollment
measure: Hospitalization Visits (Self-reported and Chart Review)
timeFrame: Week 8 after patient enrollment
measure: Total Cost (Self-reported and Chart Review)
timeFrame: Week 8 after patient enrollment
measure: End-of-life Acute Care Facility Death (Chart Review)
timeFrame: 30 days prior to death
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto
state: California
Study officials:
References: