ENCORE: Enhancing Cancer Care Of Rural Dwellers

• Sponsor: Debra Friedman (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04758338
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 700
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 121.2
• Patients Per Site: 140
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: VUMC telehealth services; Other: Interview; Other: Educational materials	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Enhancing Cancer Care Of Rural Dwellers Through Telehealth and Engagement (ENCORE)
• Actual Study Start Date: Oct 25, 2021
• Anticipated Primary Completion Date: Dec 1, 2030
• Anticipated Study Completion Date: Dec 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTS Program Arm 6-week intervention delivered via telehealth using the VUMC telehealth services.	Other: 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.; Other: Interview; 25-30 participants will be interviewed
Active Comparator: Education Attention Control Arm Receive educational materials either online, by email, or in print form.	Other: Educational materials; Participants will be provided educational materials

Outcome Measures

Primary Outcome Measures

1. Measure the effectiveness of a multi-level telehealth-based intervention [Approximately 3 years]

2. Estimate the facilitators to a future large-scale multi-level intervention [Approximately 3 years]

3. Estimate the barriers to a future large-scale multi-level intervention [Approximately 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Cancer Center- Golden Triangle Columbus	Columbus	Mississippi	United States	39705
2	Baptist Cancer Center - North Mississippi	Oxford	Mississippi	United States	38655
3	Baptist Cancer Center- Bartlett	Bartlett	Tennessee	United States	38133
4	Ballad Health Systems	Kingsport	Tennessee	United States	37660
5	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Debra Friedman
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Debra Friedman, MD, Vanderbilt-Ingram Cancer Center

Study Documents (Full-Text)

• Informed Consent Form - Dec 1, 2020

More Information

Publications

None provided.

• Responsible Party: Debra Friedman, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT04758338
• Other Study ID Numbers: VICC PED 2013; R01CA240093-01
• First Posted: Feb 17, 2021
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 10, 2022