SMART-ER: Symptom Monitoring With Patient-reported Outcomes

NCT05560685 | Terminated

• 2 other identifiers: SIB2232IRB00325375
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The key hypothesis for this study is that collection of the PRO surveys via the Outcomes4Me app is feasible, as measured by survey completion rates. In addition to informing feasibility, this study will provide information about symptom trajectories, symptom management interventions, and early endocrine therapy adherence and persistence. 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. Since symptoms and side effects are a key driver of adjuvant endocrine therapy non-adherence and non-persistence, the investigators anticipate that enhanced detection of symptoms via use of PRO surveys will result in improved symptom management and, could thereby support treatment adherence and persistence. This pilot study will assess the feasibility of the PRO survey intervention. In this pilot study, 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants using symptom monitoring survey

  Feasibility of symptom monitoring using PROs as assessed by surveys in the Outcomes4Me smart phone app. This outcome will assess the number of Participants using the symptom monitoring survey.

  14 weeks

Secondary Outcomes (2)

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

  12 Weeks

• Change in Symptoms From Baseline to 12 weeks after therapy start date

  Baseline, 12 Weeks

Study Arms (2)

Patient participants

OTHER

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.

Other: Outcomes4Me

Team Member Participants

OTHER

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.

Other: Semi-structured interview

Interventions

Outcomes4Me OTHER

Patient participants will use the outcomes4Me app to answer PROs over the first 12 weeks of endocrine therapy.

Patient participants

Semi-structured interview OTHER

Team member participants will complete a semi-structured interview.

Team Member Participants

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Age ≥ 18 years
• Able to read and understand English.
• Histologically confirmed stage I-III hormone receptor-positive invasive breast carcinoma. Hormone receptor positivity is defined as estrogen receptor and/or progesterone receptor ≥ 1% on any core biopsy or surgical specimen.
• Must be planning to initiate adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor within the next 12 weeks. Patients are not eligible if they have already initiated adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor at the time of consent.
• Concurrent ovarian suppression with a luteinizing hormone releasing hormone (LHRH) or gonadotropin releasing hormone (GnRH) analog is allowed.
• Concurrent radiation therapy is allowed.
• Concurrent human epidermal growth factor receptor 2 (HER2)-targeted therapy is allowed.
• Completed all planned diagnostic and therapeutic breast and axillary surgical procedures.
• Must have an iPhone operating system (iOS - Apple iPhone) or Android smart phone that they are able to use and download the Outcomes4Me app on.
• Must have ability to access the internet via their smart phone.
• Must be planning to receive follow-up medical oncology care at the study site for the duration of the study. Patients seen for second opinion consultation who do not intend to follow-up at the study site for the duration of the study are not eligible to participate.
• In addition to the above stated criteria, in order to be eligible to participate in this study, an individual must meet at least one of the following criteria associated with higher risk for endocrine therapy non-adherence and/or non-persistence:
• Age ≤40 years OR age ≥ 70 years.
• Self-identify as Black, African American or African.

You may not qualify if:

• Patients who have previously received tamoxifen and/or an aromatase inhibitor are not eligible to participate.
• 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.
• Receipt of chemotherapy is not allowed during study participation. Patients may have received chemotherapy prior to study participation in the study.
• Concurrent treatment with adjuvant abemaciclib is not allowed during study participation.
• Concurrent treatment with adjuvant olaparib is not allowed during study participation.
• Patients may not receive any investigational agent as part of a therapeutic clinical trial during participation in this study. Patients who previously received an investigational agent as part of a therapeutic trial and who are in follow-up for the other therapeutic trial may participate in this trial.
• Patients may not participate in another trial evaluating an intervention to support endocrine therapy adherence and/or persistence during participation in this study.
• Patients may not participate in another trial evaluating an intervention to monitor or manage symptoms during participation in this study.
• None

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Eastern Cooperative Oncology Group: collaborator
• Outcomes4Me: collaborator

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Smith KL, Tsai HL, Lim D, Wang C, Nunes R, Wilkinson MJ, Sheng JY, Couzi R, Fetting J, Riley C, Wolff AC, Santa-Maria CA, Papathakis K, Collins-Chase L, Hilton C, Thorner E, Montanari A, Ikejiani D, Snyder C, Stearns V. Feasibility of Symptom Monitoring During the First Year of Endocrine Therapy for Early Breast Cancer Using Patient-Reported Outcomes Collected via Smartphone App. JCO Oncol Pract. 2023 Nov;19(11):981-989. doi: 10.1200/OP.23.00038. Epub 2023 Sep 21.

  PMID: 37733984 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jenni Sheng, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 29, 2022
• Study Start: October 3, 2022
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (2)