Telehealth for Breast Cancer

Recruiting at 4 trial locations

Overseen By Maysa Abu-Khalaf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

305 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses video chats, online surveys, and special pill bottles to help breast cancer patients stick to their medication. It targets patients who have had surgery for hormone receptor-positive breast cancer. The tools remind patients to take their medication and provide easy ways to report side effects and get help. Tamoxifen, aromatase inhibitors, and fulvestrant have been used for decades in the therapy of hormone-receptor-positive breast cancer patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it requires that you are already on endocrine therapy prescribed by your doctor.

What data supports the effectiveness of this treatment for breast cancer?

Research shows that eHealth interventions, which include telehealth and virtual care, can improve patient engagement and health outcomes by encouraging patients to take an active role in managing their health. These interventions have been effective in improving quality of life and reducing cancer concerns in breast cancer patients. ^{1 2 3 4 5}

Is telehealth generally safe for humans?

Research on internet and digital health interventions, including telehealth, shows they are generally safe for humans. These interventions have been used for various health behaviors and conditions, such as diabetes prevention and cancer care, without significant safety concerns. ^{3 6 7 8 9}

How is the telehealth treatment for breast cancer different from other treatments?

This telehealth treatment is unique because it uses virtual care to improve adherence to therapy, manage symptoms, and reduce distress, making it more accessible for patients who face location-based barriers to care. Unlike traditional treatments, it focuses on enhancing quality of life and psychological outcomes through remote support and education. ^{10 11 12 13 14}

Research Team

Maysa Abu-Khaaf, MD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

This trial is for men and women with stage 0-III hormone receptor positive breast cancer who've had surgery. Participants need a cell phone, must be able to text, have an ECOG status of 0-2, and agree to use telehealth tools like video chat. They should not have metastatic breast cancer or be unable to use digital communication tools.

Inclusion Criteria

Signed informed consent obtained prior to any study specific assessments and procedures

I am able to get out of my bed or chair and move around.

My breast cancer stage was determined using the latest guidelines.

Exclusion Criteria

Pts who are non-English speaking and English illiterate

Patients unable to participate in patient portal communication (e.g. do not have either a smart phone, laptop, access to a computer and/ or access to a device with a webcam)

I have stage IV metastatic breast cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant endocrine therapy with telehealth support, smart pill bottles, and electronic surveys to improve adherence

12 months

Standard of care office visits every 3 months, 18 electronic surveys over one year

Follow-up

Participants are monitored for adherence, quality of life, and side effects after treatment

4 weeks

Treatment Details

Interventions

• Behavioral Intervention
• Educational Intervention
• Telemedicine

Trial Overview The study tests if telehealth improves adherence to anti-estrogen therapy after surgery in breast cancer patients. It includes best practices, behavioral and educational interventions, questionnaires on quality-of-life, surveys, and uses smart pill bottles for medication tracking.

Participant Groups

Group I: Arm III (Smart Pill Bottle, messaging) Experimental Treatment 4 Interventions

Patients receive a wireless smart pill bottle that performs daily time-specific reminders to open the pill bottle and take the medication. Additional messages are triggered by the pill bottle when non-adherence is indicated (lack of bottle opening or no change in remaining pills), as well as when medication is skipped.

Group II: Arm II (Standard of Care Office Visits, survey, telehealth) Experimental Treatment 5 Interventions

Patients receive standard of care as in Arm I and 4 automated electronic surveys every 3 weeks (+/- 1 weeks) for a total of 18 electronic surveys over one year. Patients who report severe or very severe side effects, or stopping or are thinking about stopping their ET will have a follow up encounter with a research coordinator.

Group III: Arm I (Standard of Care office Visits) Active Control 3 Interventions

Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Findings from Research

The eHealth intervention was delivered with high fidelity, with 93% of participants receiving initial training and 98.45% of expected follow-ups conducted, indicating strong program adherence.

Despite high engagement from 40.4% of users over 12 months, increased usage did not lead to significant improvements in clinical outcomes or lifestyle changes, suggesting that simply using the intervention more frequently does not guarantee better health results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. Coorey, G., Peiris, D., Scaria, A., et al.[2021]

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]

Telehealth interventions significantly improve quality of life and self-efficacy in breast cancer patients compared to usual care, based on a meta-analysis of 20 randomized controlled trials involving 2190 participants.

Patients receiving telehealth support experienced lower levels of depression, distress, and perceived stress, although anxiety levels did not show a significant difference between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of telehealth intervention on breast cancer patients' quality of life and psychological outcomes: A meta-analysis. Chen, YY., Guan, BS., Li, ZK., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Patient centered care: A path to better health outcomes through engagement and activation. [2018]

2. Canada pubmed.ncbi.nlm.nih.gov

Blended Interventions to Change Behavior in Patients With Chronic Somatic Disorders: Systematic Review. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Impact of the Method of Delivering Electronic Health Behavior Change Interventions in Survivors of Cancer on Engagement, Health Behaviors, and Health Outcomes: Systematic Review and Meta-Analysis. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Understanding how e-health interventions meet psychosocial needs of breast cancer patients: The pathways of influence on quality of life and cancer concerns. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Comparing the Effectiveness of a Web-Based Application With a Digital Live Seminar to Improve Safe Communication for Pregnant Women: 3-Group Partially Randomized Controlled Trial. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

How the Behavior Change Content of a Nationally Implemented Digital Diabetes Prevention Program Is Understood and Used by Participants: Qualitative Study of Fidelity of Receipt and Enactment. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Systematic literature review of Internet interventions across health behaviors. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Perceptions and Usability of PREVENTION: A Breast Cancer Risk Assessment e-Platform. [2023]

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

Development and Refinement of a Telehealth Intervention for Symptom Management, Distress, and Adherence to Adjuvant Endocrine Therapy after Breast Cancer. [2023]

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

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

12. England pubmed.ncbi.nlm.nih.gov

Effect of telehealth intervention on breast cancer patients' quality of life and psychological outcomes: A meta-analysis. [2018]

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

Telehealth--a change in a practice model in oncology. [2012]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of telehealth interventions on physiological and psychological outcomes in breast cancer survivors: A meta-analysis of randomised controlled trials. [2023]