CancerNCT06646614
Group Advanced Care Planning Pilot for Veterans
A study testing Group Advance Care Planning Education in people with Cancer, run by VA Palo Alto Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Group Advance Care Planning Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to consent to the study
- Plans to move within the area and leave the VA system within 4 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Cancer
- Being tested
- Group Advance Care Planning Education
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Advance Care Planning EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Group Advance Care Planning Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goals of Care Documentation
Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.
Measured: Month 2 after patient enrollment
Secondary outcomes (6)
Feeling Heard and Understood
Each patient will receive a validated Heard and Understood assessment survey. 4-item National Quality Forum-endorsed survey assessing self-perceived quality of communication with clinical care team. Each question is scored with a range of 0 to 4, with analyses comparing the proportion of patients reporting a top score (4) for a given question. The measure's reliability and validity has been assessed in a large study of outpatients with serious illness. It will be collected by self-report and self-administered assessment for each patient at Baseline and Week 8.
Measured: Baseline and Month 2 after patient enrollment
Change in patient activation using the Patient Activation Measure
Each patient will receive a validated patient activation survey (PAM-10) to assess their activation. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional "not applicable" option). Higher scores indicate greater patient activation. It will be collected for each patient by self-assessment at Baseline and Week 8.
Measured: Baseline and Month 2 after patient enrollment
Change in patient satisfaction with decision using the Satisfaction with Decision Measure
Each patient will receive a validated satisfaction with decision survey to assess their satisfaction with decision. It will be analyzed for each patient at Baseline and Week 8.
Measured: Baseline and Month 2 after patient enrollment
Palliative Care Use (Self-reported and Chart Review)
Palliative care use will be analyzed for each patient at month 6.
Measured: At Baseline and Month 6 after patient enrollment
Hospice Care Use (Self-reported and Chart Review)
Hospice care use will be analyzed at month 6.
Measured: At Baseline and Month 6 after patient enrollment
Hospitalization Visits (Self-reported and Chart Review)
Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at month 6.
Measured: At Baseline and Month 6 after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start15 Jul 2025
- Primary completion16 Jul 2026
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Manali I. Patel, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646614
- Sponsor's protocol ID
- 67728
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Advanced Care Planning Pilot for Veterans
- ClinicalTrials.gov ID
- NCT06646614
- Acronym / sponsor ID
- 67728
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 EducationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to consent to the study
- Plans to move within the area and leave the VA system within 4 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Advance Care Planning EducationThose 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. | Behavioural | Group Advance Care Planning |
Primary outcome
Goals of Care Documentation
Time frame: Month 2 after patient enrollment
Documentation of goals of care discussions will be analyzed for each patient at 8 weeks after patient enrollment.
6 secondary outcomes
Feeling Heard and Understood
Time frame: Baseline and Month 2 after patient enrollment
Change in patient activation using the Patient Activation Measure
Time frame: Baseline and Month 2 after patient enrollment
Change in patient satisfaction with decision using the Satisfaction with Decision Measure
Time frame: Baseline and Month 2 after patient enrollment
Palliative Care Use (Self-reported and Chart Review)
Time frame: At Baseline and Month 6 after patient enrollment
Hospice Care Use (Self-reported and Chart Review)
Time frame: At Baseline and Month 6 after patient enrollment
Hospitalization Visits (Self-reported and Chart Review)
Time frame: At Baseline and Month 6 after patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. We will not share.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Advance Care Planning Education in people with Cancer, run by VA Palo Alto Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goals of Care Documentation (time frame: Month 2 after patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.