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Smartphone App Monitoring for Breast Cancer Treatment (SMART-ER Trial)

N/A

Recruiting

Led By Jenni Sheng, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed stage I-III hormone receptor-positive invasive breast carcinoma

Completed all planned diagnostic and therapeutic breast and axillary surgical procedures

Must not have

Concurrent treatment with adjuvant olaparib is not allowed during study participation

Patients initiating endocrine therapy for chemoprevention for high risk disease such as lobular carcinoma in situ, ductal carcinoma in situ, atypical ductal hyperplasia and/or atypical lobular hyperplasia in the absence of invasive breast carcinoma are not eligible to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks

Awards & highlights

Summary

This trial will measure how feasible it is to collect patient-reported outcome surveys via a smartphone app to assess symptom trajectories, symptom management, and adherence to cancer treatment.

Who is the study for?

This trial is for women aged 18+ with stage I-III hormone receptor-positive invasive breast cancer. Participants must be able to use a smartphone with internet access and download the Outcomes4Me app, as they'll complete surveys on it. They should be starting adjuvant endocrine therapy soon and can't be in other symptom management or adherence trials.

What is being tested?

The study tests if using the Outcomes4Me app to collect patient-reported outcome surveys is practical by looking at how many patients finish them. It aims to see if tracking symptoms this way helps manage them better, which could improve sticking with treatment over time.

What are the potential side effects?

Since this trial involves monitoring through an app rather than testing new drugs, there are no direct side effects from medications being studied. However, participants may experience stress or discomfort when reporting their symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is hormone receptor-positive and not beyond stage III.

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I have finished all my planned breast and underarm surgeries.

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I am female.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking olaparib while participating in this study.

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I am not starting hormone therapy for conditions like LCIS, DCIS, or atypical hyperplasia without invasive breast cancer.

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I have never taken tamoxifen or aromatase inhibitors.

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I am not currently taking abemaciclib while in this study.

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I am not receiving chemotherapy while in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants using symptom monitoring survey

Secondary study objectives

Therapeutic procedure

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Trial Design

2Treatment groups

Experimental Treatment

Group I: Team Member ParticipantsExperimental Treatment1 Intervention

Feedback about the intervention will be obtained from patients and from members of the study teams and clinical teams caring for the patients who participate.

Group II: Patient participantsExperimental Treatment1 Intervention

Patients with risk factors for adjuvant endocrine therapy non-adherence or early discontinuation will complete patient-reported outcome (PRO) surveys via smart phone app at baseline and 2, 4, 8 and 12 weeks after adjuvant endocrine therapy initiation.

0 / 9Eligibility criteria met

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Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

566 Previous Clinical Trials

33,336 Total Patients Enrolled

44 Trials studying Breast Cancer

4,968 Patients Enrolled for Breast Cancer

Eastern Cooperative Oncology GroupNETWORK

268 Previous Clinical Trials

151,555 Total Patients Enrolled

30 Trials studying Breast Cancer

46,047 Patients Enrolled for Breast Cancer

Jenni Sheng, MDPrincipal InvestigatorJohns Hopkins University

Media Library

PRO Surveys via Outcomes4Me app Clinical Trial Eligibility Overview. Trial Name: NCT05560685 — N/A

Breast Cancer Research Study Groups: Patient participants, Team Member Participants

Breast Cancer Clinical Trial 2023: PRO Surveys via Outcomes4Me app Highlights & Side Effects. Trial Name: NCT05560685 — N/A

PRO Surveys via Outcomes4Me app 2023 Treatment Timeline for Medical Study. Trial Name: NCT05560685 — N/A

~0 spots leftby Oct 2024

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