Telehealth for Breast Cancer

Not currently recruiting at 4 trial locations

Overseen By Maysa Abu-Khalaf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Endocrine therapy

Disqualifiers: Stage IV cancer, Non-English, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether telehealth (also known as telemedicine) can help people adhere to their anti-estrogen therapy after breast cancer surgery. It targets individuals with hormone receptor-positive breast cancer, stages 0 to III. Participants will either attend standard office visits, use a smart pill bottle for reminders, or receive telehealth support and surveys. Those who have completed breast cancer surgery, are using endocrine therapy, and have access to digital communication tools might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for improving treatment adherence.

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 prior data suggests that telehealth is safe for improving adherence to endocrine therapy in breast cancer patients?

Research has shown that telehealth services are safe and well-received by people with breast cancer. Telemedicine allows patients to communicate with healthcare providers through video calls, improving both physical and mental health. Patients report feeling better overall and more positive about their body image. This method also manages symptoms without requiring in-person doctor visits.

In this trial, the smart pill bottle helped breast cancer survivors take their medication on time. It provides reminders, aiding patients in following their treatment plan. People generally find it helpful for managing their treatment.

Overall, both telehealth and smart pill bottles are safe and useful for managing breast cancer care. No major reports of negative effects have emerged, making them promising options for supporting treatment adherence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance breast cancer treatment through technology. Unlike traditional methods that rely solely on in-person visits, this trial includes telemedicine, smart pill bottles, and electronic surveys. The telemedicine approach allows for more frequent check-ins without needing to visit the clinic, which can make care more accessible and convenient. The smart pill bottle is a novel feature, offering reminders and monitoring adherence to medication, which could lead to better treatment outcomes by ensuring patients take their meds on time. These interventions aim to improve the patient experience and potentially boost the effectiveness of standard care practices.

What evidence suggests that telehealth is effective for improving adherence to endocrine therapy in breast cancer patients?

Research has shown that telehealth, one of the methods studied in this trial, effectively helps breast cancer patients by reducing stress and depression while making care more convenient and satisfying. It saves time and money while still providing high-quality care for post-surgery patients. Similarly, behavioral methods like cognitive-behavioral therapy (CBT), which participants in this trial may receive, have improved health and quality of life. Educational programs, another focus of this trial, increase awareness and understanding, helping patients adhere better to their treatments. Overall, these methods show promise in supporting patients during their treatment journey. ^{6 7 8 9 10}

Who Is on the Research Team?

Maysa Abu-Khaaf, MD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

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

Have access to a computer, tablet, or smart phone to complete electronic surveys

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

Exclusion Criteria

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)

Pts who are non-English speaking and English illiterate

I have stage IV metastatic breast cancer.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40366566/

Effects of CBT-based interventions on health outcomes in ... Conclusions: CBT-based interventions are effective in improving the health outcomes of patients with breast cancer. Rigorously designed randomized controlled ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000720

The effects of lifestyle and behavioural interventions on ... This study aimed to assess and compare the effects of lifestyle/behavioural interventions on cancer recurrence, survival and QoL in breast cancer survivors.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12306052/

Comparing the effectiveness of gratitude intervention and ... Comparing the effectiveness of gratitude intervention and behavioral activation technique in breast cancer patients: a randomized trial.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2347562525000101

Effects of non-pharmacological interventions on sexual ... The meta-analysis findings indicate that non-pharmacological interventions were associated with improved sexual health outcomes for patients with breast cancer.

5. link.springer.com link.springer.com/article/10.1007/s12609-024-00559-w

Psychological Intervention and Breast Cancer Psychological interventions have been found to decrease distress and improve quality of life among breast cancer patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9584037/

Effect of a Smart Pill Bottle Reminder Intervention on ... Reminder intervention using smart pill bottles was effective in improving medication adherence and medication self-efficacy among breast cancer survivors.

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Effect of a Smart Pill Bottle Reminder Intervention on... Reminder intervention using smart pill bottles was effective in improving medication adherence and medication self-efficacy among breast cancer survivors.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10398191/

Effect of a Smart Pill Bottle and Pharmacist Intervention on ... A 12-week observational study used a MAT pill bottle cap to measure adherence for 90 patients with various cancers. While the average adherence rate was 89.3%, ...

9. aacrjournals.org aacrjournals.org/cebp/article/32/1_Supplement/B119/712208/Abstract-B119-Effect-of-a-smart-pill-bottle-and

Abstract B119: Effect of a smart pill bottle and text messaging ... However, data reported that non-adherence rates range from 28% to 59%, and African American (AA) women had lower odds of being adherent to ...

10. ons.org ons.org/publications-research/cjon/25/4/mobile-health-interventions-examining-medication-adherence-outcomes

Mobile Health Interventions: Examining Medication ... This review finds that mobile health interventions are an acceptable approach that may improve adherence outcomes for patients with cancer. The findings are in ...