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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04765072
Other study ID # VICC PED 2019
Secondary ID 3P30CA068485-24S
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 26, 2021
Est. completion date February 2029

Study information

Verified date July 2023
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 33
Est. completion date February 2029
Est. primary completion date February 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Survivorship Patient Navigation Intervention
Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources
Telehealth Survivorship Visit Intervention
Individualized survivorship care plan

Locations

Country Name City State
United States Baptist Cancer Center- Bartlett Bartlett Tennessee
United States Baptist Cancer Center- Golden Triangle Columbus Columbus Mississippi
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Baptist Cancer Center - North Mississippi Oxford Mississippi

Sponsors (2)

Lead Sponsor Collaborator
Debra Friedman National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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