CancerENCORENCT04758338
Enhancing Cancer Care Of Rural Dwellers
A study testing VUMC telehealth services, Interview and Educational materials in people with Cancer, run by Debra Friedman at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- VUMC telehealth services, Interview and Educational materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Oct 2021to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Baptist Cancer Center- Bartlett
Bartlett, Tennessee, 38133
Baptist Cancer Center- Golden Triangle Columbus
Columbus, Mississippi, 39705
Ballad Health Systems
Kingsport, Tennessee, 37660
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Baptist Cancer Center - North Mississippi
Oxford, Mississippi, 38655
About this study
Official title: Enhancing Cancer Care Of Rural Dwellers Through Telehealth and Engagement (ENCORE)
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.
- Conditions
- Cancer
- Being tested
- VUMC telehealth services, Interview, Educational materials
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
InterviewOther
25-30 participants will be interviewed
Educational materialsOther
Participants will be provided educational materials
| Study group | Role | What they receive |
|---|---|---|
| CTS Program Arm | Experimental | 6-week intervention delivered via telehealth using the VUMC telehealth services. Receives: Other: VUMC telehealth services; Other: Interview |
| Education Attention Control Arm | Active comparator | Receive educational materials either online, by email, or in print form. Receives: Other: Educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the effectiveness of a multi-level telehealth-based intervention
Measured: Approximately 3 years
Estimate the facilitators to a future large-scale multi-level intervention
Measured: Approximately 3 years
Estimate the barriers to a future large-scale multi-level intervention
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start25 Oct 2021
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debra Friedman
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Debra Friedman, Vanderbilt-Ingram Cancer Center
- Investigators
- Debra Friedman, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758338
- Sponsor's protocol ID
- VICC PED 2013
- Other IDs
- R01CA240093-01
- Acronym
- ENCORE
- Status last verified
- Jul 2024
- First submitted
- 12 Feb 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cancer Care Of Rural Dwellers Through Telehealth and Engagement (ENCORE)
- ClinicalTrials.gov ID
- NCT04758338
- Acronym / sponsor ID
- ENCORE / VICC PED 2013
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Debra FriedmanUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTS Program Arm | Experimental | Other: VUMC telehealth services, Other: Interview6-week intervention delivered via telehealth using the VUMC telehealth services. |
| Education Attention Control Arm | Active comparator | Other: Educational materialsReceive educational materials either online, by email, or in print form. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VUMC telehealth servicesParticipants 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 | CTS Program Arm |
| Interview25-30 participants will be interviewed | Other | CTS Program Arm |
| Educational materialsParticipants will be provided educational materials | Other | Education Attention Control Arm |
Primary outcome
Measure the effectiveness of a multi-level telehealth-based intervention
Time frame: Approximately 3 years
Estimate the facilitators to a future large-scale multi-level intervention
Time frame: Approximately 3 years
Estimate the barriers to a future large-scale multi-level intervention
Time frame: Approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 34814868Pal 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Friedman, MD principal investigator
Vanderbilt-Ingram Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VUMC telehealth services, Interview and Educational materials in people with Cancer, run by Debra Friedman at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the effectiveness of a multi-level telehealth-based intervention (time frame: Approximately 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04758338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.