NCT04758338

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
814

participants targeted

Target at P75+ for not_applicable cancer

Timeline
67mo left

Started Oct 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2021Dec 2031

First Submitted

Initial submission to the registry

February 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

9.1 years

First QC Date

February 12, 2021

Last Update Submit

July 30, 2024

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

  • Measure the effectiveness of a multi-level telehealth-based intervention

    Approximately 3 years

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

    Approximately 3 years

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

    Approximately 3 years

Study Arms (2)

CTS Program Arm

EXPERIMENTAL

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

Other: VUMC telehealth servicesOther: Interview

Education Attention Control Arm

ACTIVE COMPARATOR

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

Other: Educational materials

Interventions

VUMC telehealth servicesOTHER

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.

CTS Program Arm
InterviewOTHER

25-30 participants will be interviewed

CTS Program Arm
Educational materialsOTHER

Participants will be provided educational materials

Education Attention Control Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Baptist Cancer Center- Golden Triangle Columbus

Columbus, Mississippi, 39705, United States

Location

Baptist Cancer Center - North Mississippi

Oxford, Mississippi, 38655, United States

Location

Baptist Cancer Center- Bartlett

Bartlett, Tennessee, 38133, United States

Location

Ballad Health Systems

Kingsport, Tennessee, 37660, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • 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.

    PMID: 34814868DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Debra Friedman, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor Investigator

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 17, 2021

Study Start

October 25, 2021

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

US(5)