Expanding Rural Health Cancer Control Capacity

Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Survivorship Patient Navigation Intervention; Behavioral: Telehealth Survivorship Visit Intervention

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Schremp; Phone Number: (615)936-2156; Email: emma.schremp@vumc.org

Study Locations

• United States
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Baptist Cancer Center- Golden Triangle Columbus
    • Oxford, Mississippi, United States, 38655
      • Baptist Cancer Center - North Mississippi
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • Baptist Cancer Center- Bartlett
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Survivorship care; 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.	Behavioral: Survivorship Patient Navigation Intervention; Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources; Behavioral: Telehealth Survivorship Visit Intervention; Individualized survivorship care plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)	Approximately 12 months
Measure effectiveness of Telehealth on survivorship care	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

Collaborators and Investigators

• Sponsor: Debra Friedman
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debra Friedman, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VICC PED 2019; 3P30CA068485-24S2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No