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Trial Title:
Group Advanced Care Planning Pilot for Veterans
NCT ID:
NCT06646614
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
explain random and two groups
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
The statistician analyzing the data will be masked from the experimental treatment and
the control. The principal investigator overseeing the trial will have access to the data
but will not know which specific arm (treatment or control) each participant belongs to.
Intervention:
Intervention type:
Behavioral
Intervention name:
Group Advance Care Planning Education
Description:
Those assigned to the group ACP arm will participate in a virtual or in-person session
every 4 weeks (2 sessions total) led by a trained health educator who is a staff member.
Sessions will introduce advanced care planning, help veterans determine their goals of
care and learn how to raise this with their oncologist, and discuss creating or updating
an advanced directive. Participants will be surveyed and interviewed to learn about their
satisfaction with 1:1 and group advance care planning education and their degree of
activation in care by a research staff member.
Arm group label:
Group Advance Care Planning
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
VA Palo Alto
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Contact:
Last name:
Madhuri Agrawal, MS
Phone:
650-304-7744
Email:
madhuri.agrawal@va.gov
Start date:
December 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Stanford University
Agency class:
Other
Collaborator:
Agency:
US Department of Veterans Affairs
Agency class:
U.S. Fed
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06646614
