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Care Coordination Educational Intervention Study for Patients From Rural Areas With Early Stage Cancer

Sponsor
University of Vermont Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05723250
Collaborator
(none)
40
Enrollment
2
Arms
22
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Care Coordination is an essential component of cancer care delivery. Many patients experience poor care coordination. In this study, we hypothesize that provision of a video educational intervention to teach patients about cancer, care coordination and self-advocacy will improve patients' perception of care coordination. Cancer patients with early stage disease scheduled to receive adjuvant therapy, and who reside in a rural area, will be enrolled onto the study. Patients will be randomized to receive a table-based educational intervention tool initially (arm1) or after 4 months of therapy (arm2). Assessment of cancer knowledge, self-advocacy and care coordination will be obtained at baseline and after 4-6 months.

Condition or Disease Intervention/Treatment Phase
  • Other: Table-based Educational Intervention
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery in Vermont: A Feasibility Study
Anticipated Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Aug 15, 2024
Anticipated Study Completion Date :
Dec 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Upfront Educational Intervention

Participants will receive a video-based intervention after completing baseline survey instruments and prior to retesting after 4-6 months.

Other: Table-based Educational Intervention
Tablet based educational tool with videos about care coordination, cancer knowledge and self-advocacy.
Other Names:
  • Educational

    		•
    Experimental: Delayed Educational Intervention

    Participants will complete baseline survey instruments and again complete surveys after 4-6 months. They will then receive the video-based educational tablet.

    Other: Table-based Educational Intervention
    Tablet based educational tool with videos about care coordination, cancer knowledge and self-advocacy.
    Other Names:
  • Educational

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Care Coordination Instrument Score at baseline and 4 months [Baseline and 4 months]

      Completion of CCI

    Secondary Outcome Measures

    1. Cancer Knowledge questionnaire [Baseline and 4 months]

      Survey completion

    2. Satisfaction survey [4 months]

      Satisfaction survey

    3. Self-Advocacy questionnaire [Baseline and 4 months]

      Self-Advocacy questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Stage I, II or III cancer To receive adjuvant medical oncology-based care Rural residence location in Vermont Proficient in English
    Exclusion Criteria:
    • History of prior malignancy treated with chemotherapy in last 3 years Known or suspected neuro-cognitive impairment Patients with current diagnosis other than stage I, II or III breast, colon or lung cancer

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Vermont Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Randall F Holcombe, Director, UVM Cancer Center, University of Vermont Medical Center
    ClinicalTrials.gov Identifier:
    NCT05723250
    Other Study ID Numbers:
    • 00002358
    First Posted:
    Feb 10, 2023
    Last Update Posted:
    Feb 10, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Randall F Holcombe, Director, UVM Cancer Center, University of Vermont Medical Center
    healthcare delivery
    care coordination
    early stage cancer
    educational intervention

    Study Results

    No Results Posted as of Feb 10, 2023