Telehealth for Breast Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byMaysa Abu-Khaaf, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

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.

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.

See 8 more

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.

Treatment Details

Interventions

Behavioral Intervention (Behavioral Intervention)
Educational Intervention (Educational Intervention)
Telemedicine (Telemedicine)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (Smart Pill Bottle, messaging)Experimental Treatment4 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 Treatment5 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 Control3 Interventions

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