Expanding Rural Health Cancer Control Capacity

NCT ID: NCT04765072

Last Updated: 2024-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2029-02-28

Brief Summary

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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

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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

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Survivorship Patient Navigation Intervention

Intervention Type BEHAVIORAL

Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources

Telehealth Survivorship Visit Intervention

Intervention Type BEHAVIORAL

Individualized survivorship care plan

Interventions

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Survivorship Patient Navigation Intervention

Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources

Intervention Type BEHAVIORAL

Telehealth Survivorship Visit Intervention

Individualized survivorship care plan

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Debra Friedman

OTHER

Sponsor Role lead

Responsible Party

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Debra Friedman

Sponsor Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Debra Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Baptist Cancer Center- Golden Triangle Columbus

Columbus, Mississippi, United States

Site Status

Baptist Cancer Center - North Mississippi

Oxford, Mississippi, United States

Site Status

Baptist Cancer Center- Bartlett

Bartlett, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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3P30CA068485-24S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC PED 2019

Identifier Type: -

Identifier Source: org_study_id

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