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RecruitingNCT05723250Updated May 4, 2026

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

An interventional study of Table-based Educational Intervention in Cancer, sponsored by University of Vermont Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Vermont Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Cancer

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Keywords

  • healthcare delivery
  • care coordination
  • early stage cancer
  • educational intervention
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherTable-based Educational Intervention

    Tablet based educational tool with videos about care coordination, cancer knowledge and self-advocacy.

    Also known as: Educational

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What researchers measure

Primary outcomes

  1. Care Coordination Instrument Score

    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.

    Time frame: Baseline and 4 months

Secondary outcomes

  1. Cancer Knowledge

    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.

    Time frame: Baseline and 4 months

  2. Satisfaction with Educational Videos

    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.

    Time frame: 4 months

  3. Self-Advocacy Score

    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.

    Time frame: Baseline and 4 months

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Study locations

1 of 1 sites recruiting
  • University of Vermont Cancer Center
    Burlington, Vermont 05405, United States
    • Randall F Holcombe · Contact
    Recruiting
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References and documents

Publications

  • Okado I, Cassel K, Pagano I, Holcombe RF. Development and psychometric evaluation of a questionnaire to measure cancer patients' perception of care coordination. BMC Health Serv Res. 2020 Jan 21;20(1):52. doi: 10.1186/s12913-020-4905-4. PubMed 31964391 ↗
  • Okado I, Cassel K, Pagano I, Holcombe RF. Assessing Patients' Perceptions of Cancer Care Coordination in a Community-Based Setting. JCO Oncol Pract. 2020 Aug;16(8):e726-e733. doi: 10.1200/JOP.19.00509. Epub 2020 Mar 27. PubMed 32216713 ↗
  • Okado I, Pagano I, Cassel K, Holcombe RF. Perceptions of care coordination in cancer patient-family caregiver dyads. Support Care Cancer. 2021 May;29(5):2645-2652. doi: 10.1007/s00520-020-05764-8. Epub 2020 Sep 24. PubMed 32970231 ↗

Individual participant data

Plan to share: Yes — Upon request, with removal of PHI

Supporting information: Study protocol

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Registry details

Key details

Study ID
NCT05723250
Lead sponsor
University of Vermont Medical Center
Responsible party
Randall F Holcombe (Director, UVM Cancer Center, University of Vermont Medical Center) — Principal investigator
First posted
Feb 10, 2023
Start date
Mar 31, 2023
Primary completion
Sep 30, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
May 4, 2026

Study contacts

Randall F Holcombe
Contact
randall.holcombe@med.uvm.edu
18026563812

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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