Expanding Rural Health Cancer Control Capacity

Not Applicable

Active, not recruiting

• Conditions: Cancer
• Interventions: Behavioral: Survivorship Patient Navigation Intervention; Behavioral: Telehealth Survivorship Visit Intervention

• Registration Number: NCT04765072
• Lead Sponsor: Debra Friedman

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

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Study Start: 2021-02-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-15
• Primary Completion: 2028-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Survivorship care	Survivorship Patient Navigation Intervention	Participants in rural areas will receive a telehealth (providing health-related services through electronic communication technologies) survivorship care plan in combination with assistance from a patient navigator.
Survivorship care	Telehealth Survivorship Visit Intervention	Participants in rural areas will receive a telehealth (providing health-related services through electronic communication technologies) survivorship care plan in combination with assistance from a patient navigator.

Primary Outcome Measures

Name	Time	Method
Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)	Approximately 12 months
Estimate the facilitators to a future larger-scale implementation of guideline-based survivorship care planning in rural settings	Approximately 1 year
Estimate the barriers to a future larger-scale implementation of guideline-based survivorship care planning in rural settings	Approximately 1 year
Measure effectiveness of Telehealth on survivorship care	Approximately 12 months

Trial Locations

Locations (4)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Baptist Cancer Center - North Mississippi; 🇺🇸 Oxford, Mississippi, United States

Baptist Cancer Center- Bartlett; 🇺🇸 Bartlett, Tennessee, United States

Baptist Cancer Center- Golden Triangle Columbus; 🇺🇸 Columbus, Mississippi, United States