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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05723250
• Other study ID #: 00002358
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2023
• Source: University of Vermont Medical Center
• Contact: Randall F Holcombe
• Phone: 18026563812
• Email: randall.holcombe[@]med.uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Vermont Cancer Center	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and 4 months
Secondary	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.	4 months
Secondary	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.	Baseline and 4 months