Clinical trial NCT05723250: Care Coordination Educational Intervention Study for Patients from Rural Areas with Early Stage Cancer
Official title: Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery in Vermont: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: healthcare delivery
care coordination
early stage cancer
educational intervention
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Care Coordination Instrument Score
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Cancer Knowledge
timeFrame: Baseline and 4 months
measure: Satisfaction with Educational Videos
timeFrame: 4 months
measure: Self-Advocacy Score
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Cancer Center
state: Vermont
Study officials:
References:
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.
citation: 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.
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.