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Active, not recruitingNCT04758338ENCOREUpdated Jul 31, 2024

Enhancing Cancer Care Of Rural Dwellers

An interventional study of VUMC telehealth services and Interview in Cancer, sponsored by Debra Friedman. Active, not recruiting at 5 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Debra Friedman · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
814
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.
02

Conditions studied

  • Cancer
03

In context

Lead sponsor

Debra Friedman is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
814 participants (actual)

Study arms

  • Experimental
    CTS Program Arm

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

    Other: VUMC telehealth services · Other: Interview

  • Active comparator
    Education Attention Control Arm

    Receive educational materials either online, by email, or in print form.

    Other: Educational materials

Interventions

  • OtherVUMC 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.

  • OtherInterview

    25-30 participants will be interviewed

  • OtherEducational materials

    Participants will be provided educational materials

06

What researchers measure

Primary outcomes

  1. Measure the effectiveness of a multi-level telehealth-based intervention

    Time frame: Approximately 3 years

  2. Estimate the facilitators to a future large-scale multi-level intervention

    Time frame: Approximately 3 years

  3. Estimate the barriers to a future large-scale multi-level intervention

    Time frame: Approximately 3 years

07

Study locations

5 sites
  • Baptist Cancer Center- Golden Triangle Columbus
    Columbus, Mississippi 39705, United States
  • Baptist Cancer Center - North Mississippi
    Oxford, Mississippi 38655, United States
  • Baptist Cancer Center- Bartlett
    Bartlett, Tennessee 38133, United States
  • Ballad Health Systems
    Kingsport, Tennessee 37660, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee 37232, United States
08

References and documents

Publications

  • 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. PubMed 34814868 ↗

Study documents

  • Informed consent form · Dec 1, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04758338
Lead sponsor
Debra Friedman
Collaborators
National Cancer Institute (NCI)
Responsible party
Debra Friedman (Sponsor Investigator, Vanderbilt-Ingram Cancer Center) — Sponsor-investigator
First posted
Feb 17, 2021
Start date
Oct 25, 2021
Primary completion
Dec 2030 (estimated)
Completion
Dec 2031 (estimated)
Last update
Jul 31, 2024

Study contacts

Debra Friedman, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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