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

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

Compensation: Varies

Number of Visits: Unknown

814 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Telehealth Services for Cancer Care in Rural Areas?

Research shows that eHealth interventions, like telehealth, help improve access to cancer care for rural patients by overcoming location-based barriers. Additionally, self-management education has been found effective in helping cancer patients manage their disease and treatment effects. ^{1 2 3 4 5}

Is telehealth for cancer care safe for humans?

Research on educational and self-management programs for cancer patients, including telehealth services, suggests they are generally safe. These programs help patients manage side effects and improve their understanding of treatment, which can reduce adverse events and hospital visits. ^{6 7 8 9 10}

How does this treatment differ from other treatments for cancer care in rural areas?

This treatment uses telehealth services to provide cancer care to patients in rural areas, making it unique by improving access to healthcare, reducing travel burdens, and supporting patient-provider communication through remote technologies like video-assisted chemotherapy and eHealth interventions. ^{2 11 12 13 14}

Research Team

Debra L. Friedman

Principal Investigator

Vanderbilt-Ingram Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Self-management education interventions for patients with cancer: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Access to Care: Using eHealth to Limit Location-Based Barriers for Patients With Cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Identifying health literacy and health system navigation needs among rural cancer patients: findings from the Rural Oncology Literacy Enhancement Study (ROLES). [2021]

4. Scotland pubmed.ncbi.nlm.nih.gov

Patient-centered care coordination, education and counseling of patients treated with oral anticancer drugs: An importance-performance analysis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Implementation of an evidence-based education practice change for patients with cancer. [2014]

6. England 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. [2020]

7. France pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. [2017]

8. France pubmed.ncbi.nlm.nih.gov

[Impact of a coordinated regional organization to secure the management of patients on oral anticancer drugs: CHIMORAL, a comparative trial]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Empowering individuals to self-manage chemotherapy side effects. [2022]

10. Canada 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Enhancing access to cancer education for rural healthcare providers via telehealth. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Telehealth Is a Sustainable Population Health Strategy to Lower Costs and Increase Quality of Health Care in Rural Utah. [2020]

13. Australia pubmed.ncbi.nlm.nih.gov

'The best thing since sliced bread': Patient experiences of teleoncology in western NSW. [2023]

14. Canada pubmed.ncbi.nlm.nih.gov

E-Clinic: an innovative approach to complex symptom management for allogeneic blood and stem cell transplant patients. [2019]