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

NCT05723250 | Recruiting DMC

• 1 other identifier: 00002358
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

healthcare delivery; care coordination; early stage cancer; educational intervention

Outcome Measures

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.

  Baseline and 4 months

Secondary Outcomes (3)

• Cancer Knowledge

  Baseline and 4 months

• Satisfaction with Educational Videos

  4 months

• Self-Advocacy Score

  Baseline and 4 months

Study Arms (2)

Upfront Educational Intervention

EXPERIMENTAL

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

Delayed Educational Intervention

EXPERIMENTAL

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

Table-based Educational Intervention OTHER

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

Also known as: Educational

Delayed Educational Intervention; Upfront Educational Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Cancer Center

Burlington, Vermont, 05405, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 31964391 BACKGROUND

• 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.

  PMID: 32216713 BACKGROUND

• 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.

  PMID: 32970231 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Randall F Holcombe

CONTACT

18026563812; randall.holcombe@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, UVM Cancer Center

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: March 31, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)