Clinical trial NCT04765072: Expanding Rural Health Cancer Control Capacity
Official title: Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-02-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.

Detailed description: Study Aims:

* Pilot test the implementation of guideline-based survivorship care planning in a rural setting using patient navigation plus telehealth among underserved rural cancer survivors. Investigators will collect feasibility data on patient recruitment rates and the ability to measure clinical effectiveness outcomes using the electronic health record and patient reports (survivor adherence to recommended disease surveillance, health assessment and cancer prevention/early detection practices).
* Identify the facilitators and barriers to future larger scale implementation of guideline-based survivorship care planning in rural settings to optimize the implementation strategies. Through a mixed methods approach, investigators will address implementation research questions focused on "real world" implementation of the guideline-based intervention in rural areas, including barriers/facilitators and translation to other rural settings. This will allow us to optimize the implementation strategies that will be further evaluated in the future large-scale implementation trial

Eligibility criteria: Inclusion Criteria:

* Cancer patient at least 18 years of age at time of cancer therapy
* English-speaking with the ability to provide informed consent
* Received treatment for Stage 0 - III cancer with curative intent
* Completed cancer therapy within the previous 12 months (i.e., 12 months prior to consenting) and in complete remission

Primary outcomes:
measure: Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)
timeFrame: Approximately 12 months
measure: Measure effectiveness of Telehealth on survivorship care
timeFrame: Approximately 12 months
measure: Estimate the facilitators to a future larger-scale implementation of guideline-based survivorship care planning in rural settings
timeFrame: Approximately 1 year
measure: Estimate the barriers to a future larger-scale implementation of guideline-based survivorship care planning in rural settings
timeFrame: Approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Baptist Cancer Center- Golden Triangle Columbus
state: Mississippi
city: Oxford
country: United States
facility: Baptist Cancer Center - North Mississippi
state: Mississippi
city: Bartlett
country: United States
facility: Baptist Cancer Center- Bartlett
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Debra Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: