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Clinical Trials/NCT04765072
NCT04765072
Active, not recruiting
Not Applicable

Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship

Debra Friedman4 sites in 1 country33 target enrollmentFebruary 26, 2021
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Debra Friedman
Enrollment
33
Locations
4
Primary Endpoint
Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)
Status
Active, not recruiting
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
February 26, 2021
End Date
February 2029
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Debra Friedman
Responsible Party
Sponsor Investigator
Principal Investigator

Debra Friedman

Sponsor Investigator

Vanderbilt-Ingram Cancer Center

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)

Time Frame: Approximately 12 months

Estimate the facilitators to a future larger-scale implementation of guideline-based survivorship care planning in rural settings

Time Frame: Approximately 1 year

Estimate the barriers to a future larger-scale implementation of guideline-based survivorship care planning in rural settings

Time Frame: Approximately 1 year

Measure effectiveness of Telehealth on survivorship care

Time Frame: Approximately 12 months

Study Sites (4)

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