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

April 27, 2026 updated by: Randall F Holcombe, University of Vermont Medical Center

Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery in Vermont: A Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont Cancer Center
        • Contact:
          • Randall F Holcombe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18+ years of age
  • Breast, lung, or colon cancer diagnosis
  • Stage I, II or III cancer
  • Adjuvant chemotherapy started < 30 days or planned within the next 30 days
  • Rural residence location in Vermont (outside Chittenden County)
  • Proficient in English

Exclusion Criteria:

  • History of prior malignancy treated with chemotherapy in last 3 years
  • Known or suspected neuro-cognitive impairment
  • Resident of Chittenden County, Vermont
  • Patients with current diagnosis other than stage I, II or III breast, colon or lung cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Care Coordination Instrument Score
Time Frame: Baseline and 4 months
Participants complete the Care Coordination Instrument (CCI), a 29-item questionnaire. Each item is rated on a Likert scale (Strongly Agree = 3 to Strongly Disagree = 0). A total score is generated by summing the item scores; possible total scores range from 0-87. Higher scores represent a greater perception of care coordination.
Baseline and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Knowledge
Time Frame: Baseline and 4 months
Participants complete the Cancer Knowledge Assessment Test (C-KAT). The test includes 5 multiple choice items. A total score is generated by summing the number of correct responses; total scores range from 0-5. Higher scores represent greater cancer knowledge.
Baseline and 4 months
Satisfaction with Educational Videos
Time Frame: 4 months
Participants in the baseline intervention group complete the Satisfaction and Acceptability Questionnaire. This 5-item questionnaire assesses how helpful and easily accessible the educational videos were. There is also an open-ended question for other feedback. Answering yes to the items indicates greater satisfaction and ease of use.
4 months
Self-Advocacy Score
Time Frame: Baseline and 4 months
Participants complete the Cancer Self-Advocacy Scale, a 20-item questionnaire. Each item is rated on a Likert scale (Strongly Agree = 6 to Strongly Disagree = 1). A total score is generated by summing the item scores; possible total scores range from 20-120. Higher scores represent greater self-advocacy skills.
Baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request, with removal of PHI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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