Telehealth Services for Cancer Care in Rural Areas

(ENCORE Trial)

Recruiting at 4 trial locations

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Debra Friedman

Disqualifiers: Non-English speakers, Under 21, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

814 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve cancer care for people in rural areas with limited resources by using telehealth services. It will test whether remote educational materials and a 6-week telehealth program can enhance cancer care delivery. Participants may either receive educational materials or engage in a telehealth intervention through Vanderbilt University Medical Center's telehealth services. Individuals newly diagnosed or experiencing a cancer relapse and seeing specific oncology providers might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions in cancer care for underserved communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these telehealth services are safe for cancer care in rural areas?

Research has shown that telehealth services, like those used in this trial, are safe for cancer patients. Studies have found that telemedicine for cancer care does not increase emergency room visits, making it a safe alternative to regular in-person visits. One study found no negative effects from using telehealth for cancer care in rural areas, indicating that the treatment is well-tolerated and does not cause harm. Participants using telehealth services for this trial can feel confident about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving cancer care in rural areas through telehealth. Unlike traditional in-person visits, this approach uses VUMC telehealth services to provide a 6-week intervention, making it accessible to patients who might otherwise face geographical barriers. Additionally, the trial includes the distribution of educational materials, offering patients valuable information in various formats like online or print, which can empower them to better understand and manage their condition. This innovative use of technology and education could enhance patient engagement and care accessibility in underserved regions.

What evidence suggests that this trial's treatments could be effective for cancer care in rural areas?

Research has shown that telehealth services effectively provide cancer care to people in rural areas. Studies have found that telehealth assists with cancer screening, treatment, and support, which is crucial for those living far from major healthcare centers. Evidence suggests that telehealth improves care quality by facilitating access to specialists and treatment options. In this trial, participants in the CTS Program Arm will receive a 6-week intervention via telehealth using VUMC telehealth services. Meanwhile, participants in the Education Attention Control Arm will receive educational materials online, by email, or in print. Previous telehealth programs have successfully increased access to cancer care in rural communities, leading to better health outcomes. ^{4 5 6 7 8}

Who Is on the Research Team?

Debra L. Friedman

Principal Investigator

Vanderbilt-Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 21 or older who can consent to participate. It includes oncology providers within certain practices and their newly diagnosed or relapsed cancer patients. Both the provider and patient must be part of the study.

Inclusion Criteria

I am 21 or older, speak English, and can give informed consent.

Oncology providers within designated VHAN oncology practices

Provider and Patient:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 6-week telehealth-based intervention using VUMC telehealth services

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Educational materials
• Interview
• VUMC telehealth services

Trial Overview The trial tests a multi-level remote intervention using telehealth services, interviews, and educational materials aimed at enhancing cancer care for rural residents with limited access to comprehensive treatment facilities.

How Is the Trial Designed?

Group I: CTS Program Arm Experimental Treatment 2 Interventions

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

Group II: Education Attention Control Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Debra Friedman

Lead Sponsor

Trials

2

Recruited

850+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 101 adult cancer patients undergoing chemotherapy, 83% reported experiencing adverse events, highlighting the common side effects of anticancer drugs.

The research found that 11% of adverse events and a significant portion of medical consultations and hospitalizations were linked to a lack of therapeutic education, emphasizing the need for better patient education on treatment and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Santucci, R., Aatmani, AE., Lescoute, A., et al.[2017]

An 11-minute educational DVD combined with a group discussion led by an oncology nurse effectively improved patients' understanding of chemotherapy side effects and self-care management.

Surveys conducted after the class and at an eight-week follow-up indicated that this approach empowered patients and families, enhancing their confidence in managing side effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering individuals to self-manage chemotherapy side effects. Fee-Schroeder, K., Howell, L., Kokal, J., et al.[2022]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

In a study involving 85 healthcare professionals and patients across four Belgian hospitals, over half of the evaluated key elements for patient-centered care in oral anticancer drug treatment were found to be either not performed or not systematically performed, particularly in areas like care coordination and medication counseling.

Despite the moderate performance of these key elements, nearly all participants rated them as highly important, indicating a significant gap between perceived importance and actual implementation, highlighting the need for improved strategies in patient education and care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered care coordination, education and counseling of patients treated with oral anticancer drugs: An importance-performance analysis. Kinnaer, LM., Nelis, M., Van Hecke, A., et al.[2020]

eHealth interventions, like televisits and remote patient monitoring, can significantly improve access to cancer care for patients in both rural and urban communities by overcoming barriers to timely screening and treatment.

Successful implementation of eHealth programs has been shown to enhance patient-provider communication and transform care delivery, ultimately leading to better quality cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to Care: Using eHealth to Limit Location-Based Barriers for Patients With Cancer. Baldwin-Medsker, A., Holland, J., Rodriguez, ES.[2021]

A quality improvement project at a community cancer center focused on enhancing patient education for cancer patients, addressing the high anxiety levels that can hinder information retention.

The pilot study introduced a one-hour separate patient education visit, which received positive feedback from both patients and oncology nurses, indicating satisfaction with the standardized education approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an evidence-based education practice change for patients with cancer. Portz, D., Johnston, MP.[2014]

A pharmacist-led program effectively managed adverse events in 123 patients with EGFR mutation-positive non-small cell lung cancer receiving afatinib, highlighting the importance of patient education and proactive monitoring in a community oncology setting.

Common adverse events included diarrhea (85%) and rash/skin reactions (58%), with 13% of patients discontinuing treatment due to these side effects; however, those who continued treatment often had dose reductions, indicating a strategy to maintain therapy despite adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting. Khrystolubova, N., Shieh, M., Patel, AJ., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34814868/

Enhancing Cancer care of rural dwellers through telehealth ... Enhancing Cancer care of rural dwellers through telehealth and engagement (ENCORE): protocol to evaluate effectiveness of a multi-level ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-021-08949-4

Enhancing Cancer care of rural dwellers through telehealth ... Telehealth has been successfully used for cancer screening, treatment, and supportive care [21,22,23,24,25,26], and been expanded even further ...

3. cdn.vanderbilt.edu cdn.vanderbilt.edu/vu-wordpress-0/wp-content/uploads/sites/16/2023/05/27173600/schwartz_article_final.pdf

Identifying the Status of Telehealth for Cancer Patients in ... After analyzing the results, we suggest the best improvements to increase the effectiveness and quality of cancer care in the rural northeastern United States.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04758338

NCT04758338 | Enhancing Cancer Care Of Rural Dwellers Objectives: Evaluate the clinical effectiveness of a multi-level telehealth-based intervention for rural hospitals consisting of provider access to tumor board ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-05688

Educational Telehealth Program for the Delivery of Care to ... This clinical trial evaluates the clinical effectiveness of a multi-level telehealth-based intervention for cancer patients in rural communities.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36493388/

Telemedicine Use for Oncology Clinic Visits at a Large ... Of 18 cancer sites, breast cancers had the highest proportion (29.04%) of tele-oncology visits. There was no significant difference in January ...

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1089/tmj.2022.0294

Telemedicine Use for Oncology Clinic Visits at a Large ... Telemedicine use was not associated with increased ED visits for oncology patients, suggesting telemedicine as an alternative for routine oncology clinics.

8. wp0.vanderbilt.edu wp0.vanderbilt.edu/youngscientistjournal/article/identifying-the-status-of-telehealth-for-cancer-patients-in-the-rural-northeastern-united-states

Identifying the Status of Telehealth for Cancer Patients in ... Additionally, this data demonstrated that telehealth had no perceived adverse or negative effects on cancer care in the rural northeastern ...