Expanding Rural Health Cancer Control Capacity

Sponsor

Debra Friedman (Other)

Overall Status

Recruiting

CT.gov ID

NCT04765072

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

95.2

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Survivorship Patient Navigation Intervention Behavioral: Telehealth Survivorship Visit Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship

Actual Study Start Date :

Feb 26, 2021

Anticipated Primary Completion Date :

Feb 1, 2028

Anticipated Study Completion Date :

Feb 1, 2029

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Cancer Center- Golden Triangle Columbus	Columbus	Mississippi	United States	39705
2	Baptist Cancer Center - North Mississippi	Oxford	Mississippi	United States	38655
3	Baptist Cancer Center- Bartlett	Bartlett	Tennessee	United States	38133
4	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Debra Friedman
National Cancer Institute (NCI)

Investigators

Principal Investigator: Debra Friedman, MD, Vanderbilt-Ingram Cancer Center

Study Documents (Full-Text)

Informed Consent Form - Dec 1, 2020

More Information

Publications

None provided.

Responsible Party:

Debra Friedman, Sponsor Investigator, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT04765072

Other Study ID Numbers:

VICC PED 2019
3P30CA068485-24S2

First Posted:

Feb 21, 2021

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 20, 2022