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Smartphone App Monitoring for Breast Cancer Treatment (SMART-ER Trial)
N/A
Recruiting
Led By Karen Smith, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
SMART-ER Trial 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.Check my eligibility
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.See study design
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.
SMART-ER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
SMART-ER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants using symptom monitoring survey
Secondary outcome measures
Therapeutic procedure
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
SMART-ER 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.
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,879 Total Patients Enrolled
43 Trials studying Breast Cancer
4,938 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
Karen Smith, MDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
656 Total Patients Enrolled
1 Trials studying Breast Cancer
3 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently taking olaparib while participating in this study.Along with the previous requirements, you should be either younger than 40 or older than 70, identify as Black or African, take medication for depression or anxiety, have certain health conditions, or report moderate to severe symptoms.My breast cancer is hormone receptor-positive and not beyond stage III.I have finished all my planned breast and underarm surgeries.I am female.I am not starting hormone therapy for conditions like LCIS, DCIS, or atypical hyperplasia without invasive breast cancer.I am 18 years old or older.I am currently receiving radiation therapy.I am currently receiving HER2-targeted therapy.I have never taken tamoxifen or aromatase inhibitors.I am not currently taking abemaciclib while in this study.I am not receiving chemotherapy while in this study.I plan to start hormone therapy with tamoxifen or an aromatase inhibitor soon.I am receiving hormone therapy to suppress ovarian function.
Research Study Groups:
This trial has the following groups:- Group 1: Patient participants
- Group 2: Team Member Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total sample size of individuals participating in this trial?
"Affirmative. Clinicaltrials.gov verifies that this medical experiment, first posted on October 3rd 2022, is presently enrolling patients. 40 volunteers will be recruited from two locations for the trial's progression."
Answered by AI
Are there any openings for participation in this experiment?
"Clinicaltrials.gov confirms that this clinical trial, which was first posted on October 3rd 2022, is actively enrolling participants. The data associated with the study has been recently updated as of October 24th 2022."
Answered by AI
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