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NCT02966509 · REGISTRY CONDITION SEARCH

Engagement of Patients With Advanced Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2018-10-31

The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.

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outcome · POSTED

Emergency Department Visit (Chart Review)

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outcome · POSTED

Emergency Department Visit (Chart Review)

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outcome · POSTED

Hospitalization Visits (Chart Review)

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outcome · POSTED

Hospitalization Visits (Chart Review)

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outcome · POSTED

Hospice Referral (Chart Review)

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outcome · POSTED

Palliative Care Referral (Chart Review)

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outcome · POSTED

Palliative Care Referral (Chart Review)

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outcome · POSTED

Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey

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outcome · POSTED

Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Newly diagnosed stage III or IV cancer * Recurrent disease (any stage) * Ability to consent to study Exclusion Criteria: * Patients who are unable to consent to study procedures
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care.
    intervention Names
    1. Behavioral: EPAC
    label
    A: Intervention Arm
    type
    EXPERIMENTAL
  2. description
    All participants randomized to Arm B will receive usual oncologic care.
    label
    B: Control Group Arm
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. A: Intervention Arm
    description
    Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
    name
    EPAC
    type
    BEHAVIORAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
SINGLE
who Masked
  1. INVESTIGATOR
primary Purpose
HEALTH_SERVICES_RESEARCH
Enrollment
count
213
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.
    measure
    Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.
    time Frame
    6 months after each patient enrollment
secondary Outcomes
  1. description
    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    measure
    Emergency Department Visit (Chart Review)
    time Frame
    6 months after patient enrollment
  2. description
    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    measure
    Emergency Department Visit (Chart Review)
    time Frame
    15 months after patient enrollment
  3. description
    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    measure
    Hospitalization Visits (Chart Review)
    time Frame
    6 months after patient enrollment
  4. description
    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    measure
    Hospitalization Visits (Chart Review)
    time Frame
    15 months after patient enrollment
  5. description
    Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    measure
    Hospice Referral (Chart Review)
    time Frame
    6 months after patient enrollment
  6. description
    Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    measure
    Palliative Care Referral (Chart Review)
    time Frame
    6 months after patient enrollment
  7. description
    Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    measure
    Palliative Care Referral (Chart Review)
    time Frame
    15 months after patient enrollment
  8. description
    Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.
    measure
    Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey
    time Frame
    Change in Patient Satisfaction with Care from baseline to 6 months.
  9. description
    Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.
    measure
    Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
    time Frame
    6 months
Full study description
brief Summary
The Engagement of Patients with Advanced Cancer is an intervention that utilizes well-trained lay health coaches to engage patients and their families in goals of care and shared decision-making after a diagnosis of advanced cancer. Although lay health workers have never been tested in this role, we hypothesize that lay health workers can feasibly improve goals of care documentation and help to reduce unwanted healthcare utilization at the end of life for Veterans diagnosed with new advanced stages of cancer and those diagnosed with recurrent disease.
detailed Description
VAPAHCS proposes to implement and evaluate several critical elements to be in alignment with the VHA's Strategic Goal and priority areas for FY2013. The Engagement of Patients with Advanced Cancer project is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Veterans with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals with advanced cancer who have advanced cancer (stages III, IV or recurrent disease). The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved patient experiences, outcomes, and that the program helps to reduce utilization of health care resources at the end of life.
Source references
references
  1. citation
    Patel MI, Agrawal M, Blayney DW, Bundorf MK, Milstein A. Long-Term Engagement of Patients With Advanced Cancer: Results From the EPAC Randomized Clinical Trial. JAMA Oncol. 2024 Jul 1;10(7):905-911. doi: 10.1001/jamaoncol.2024.1221.
    pmid
    38814627
    type
    DERIVED
  2. citation
    Patel MI, Sundaram V, Desai M, Periyakoil VS, Kahn JS, Bhattacharya J, Asch SM, Milstein A, Bundorf MK. Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2018 Oct 1;4(10):1359-1366. doi: 10.1001/jamaoncol.2018.2446.
    pmid
    30054634
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-083fe0edbb6f9b108a8f
      requested nct id
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      primary nct id
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      source kind
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      source record id
      Source null
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      payload sha256
      46a598444391d6f8d20f563978294e6f34636cd2543734e494e1f2e638fe9c7a
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-083fe0edbb6f9b108a8f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT02966509
        end
        11
        exact text
        NCT02966509
        start
        0
      offset unit
      unicode_code_points
      query cond
      Testicular Cancer
      query disease state id
      ds-testicular-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      source json pointer
      /studies/53/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      63a4c6be457a094f49b947ca3e99463157c9e3ac712ffea05ccff822f9de6277

    Preserved source evidence · Not medical advice