Enhancing Cancer Care Of Rural Dwellers

NCT ID: NCT04758338

Last Updated: 2024-07-31

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

814 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2031-12-31

Brief Summary

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Through a multi-level remote intervention, the Vanderbilt-Ingram Cancer Center (VICC) seeks to improve comprehensive cancer care delivery to patients residing in rural communities with persistent poverty. We plan to do this by using telehealth to broaden the reach of our NCI-designated comprehensive cancer center in these communities

Detailed Description

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Objectives:

* Evaluate the clinical effectiveness of a multi-level telehealth-based intervention for rural hospitals consisting of provider access to tumor board expertise that incorporates disease, patient and molecular tumor characteristics, together with patient access to a supportive care intervention to improve cancer care delivery.
* Evaluate the facilitators and barriers to future larger-scale dissemination and implementation of the multi-level intervention, designed to enhance quality rural cancer care delivery.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CTS Program Arm

6-week intervention delivered via telehealth using the VUMC telehealth services.

Group Type EXPERIMENTAL

VUMC telehealth services

Intervention Type OTHER

Participants will access the CTS link (sent to them via email), which will connect them directly to a videoconference and enable them to see and hear the facilitators and other patients in the group.

Interview

Intervention Type OTHER

25-30 participants will be interviewed

Education Attention Control Arm

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Group Type ACTIVE_COMPARATOR

Educational materials

Intervention Type OTHER

Participants will be provided educational materials

Interventions

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VUMC telehealth services

Participants will access the CTS link (sent to them via email), which will connect them directly to a videoconference and enable them to see and hear the facilitators and other patients in the group.

Intervention Type OTHER

Interview

25-30 participants will be interviewed

Intervention Type OTHER

Educational materials

Participants will be provided educational materials

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Provider and Patient:

\- At least 21 years of age or older and English speaking with the ability to provide informed consent

* Oncology providers within designated VHAN oncology practices
* Newly diagnosed or relapsed cancer patients of aforementioned oncology providers
Minimum Eligible Age

21 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

Ballad Health Systems

Kingsport, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Pal T, Hull PC, Koyama T, Lammers P, Martinez D, McArthy J, Schremp E, Tezak A, Washburn A, Whisenant JG, Friedman DL. Enhancing Cancer care of rural dwellers through telehealth and engagement (ENCORE): protocol to evaluate effectiveness of a multi-level telehealth-based intervention to improve rural cancer care delivery. BMC Cancer. 2021 Nov 23;21(1):1262. doi: 10.1186/s12885-021-08949-4.

Reference Type DERIVED
PMID: 34814868 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA240093-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC PED 2013

Identifier Type: -

Identifier Source: org_study_id

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