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Breast CancerSMART-ERNCT05560685

SMART-ER: Symptom Monitoring With Patient-reported Outcomes

A study testing Outcomes4Me and Semi-structured interview in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Outcomes4Me and Semi-structured interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
3 Oct 2022to 6 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • On medication for depression and/or anxiety.
  • At least one of the following comorbid health conditions (mark all that apply):
  • Congestive heart failure
  • Valvular disease
  • Pulmonary circulation disorder
  • Peripheral vascular disorder
  • Hypertension
  • Paralysis
  • Neurodegenerative disorder/Dementia
  • Chronic pulmonary disease
  • Diabetes
  • Hypothyroid
  • Renal disease
  • Liver disease
  • Peptic ulcer disease
  • Acquired Immune Deficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection
  • Rheumatoid arthritis/collagen vascular disease
  • Coagulopathy
  • Obesity
  • Weight loss
  • Fluid/electrolyte disorder
  • Anemia
  • Alcohol abuse
  • Drug abuse
  • Psychosis
  • Depression
  • Self-report one or more symptom of at least moderate severity, defined as ≥ 4 on a 0-10 point scale.
  • Study Team/Clinical Team Member Inclusion Criteria
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Provision of written informed consent.
  • Stated willingness to comply with study procedures.
  • A member of the study team or clinical team at a Johns Hopkins or Virginia Commonwealth University clinical site where at least 2 patient participants have enrolled, at least one of whom has passed the T2 survey time point and at least one of whom has had an alert for a severe or worsening symptom.
  • Able to participate in an interview in English.

Who cannot join

  • 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.
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  • 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.
  • Study Team Member Exclusion Criteria
  • None

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: SMART-ER: A Pilot Study to Assess the Feasibility of Symptom Monitoring With Patient-reported Outcomes Collected Via Smart Phone App in Patients With Estrogen and/or Progesterone Receptor-positive Stage I-III Breast Cancer at Risk for Adjuvant Endocrine Therapy Non-adherence or Early Discontinuation

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.

Read the detailed description

Consenting patient participants will complete PRO surveys at baseline (T0) and 2 (T1), 4 (T2), 8 (T3) and 12 weeks (T4) after endocrine therapy initiation. Surveys will be administered within the Outcomes4Me smart phone app. Each survey will include 15 PRO-CTCAE items about common symptoms during adjuvant endocrine therapy. In addition, patient participants will self-report participants' endocrine therapy at each time point. Demographics and financial hardship will be assessed at baseline. Quality of life will be assessed at baseline and 12 weeks after endocrine therapy initiation. Global bother due to side effects of treatment will be assessed at each time point with the Functional Assessment of Cancer (FACT-B) General Population (GP5) item. Patient participants will also complete a single item from the Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) to assess overall adherence at 2, 4 and 8 weeks after endocrine therapy initiation and the entire PMAS 12 weeks after endocrine therapy initiation. In addition, patient participants will report participants' co-payment and pharmacy 2 weeks after endocrine therapy initiation and symptom management interventions the participants have pursued 12 weeks after endocrine therapy initiation. The clinical teams will be alerted if patient participants report severe or worsening symptoms exceeding pre-defined thresholds on the PRO-CTCAE questions. Both patients and members of the clinical team will be offered information about evidence-based symptom management strategies. Patients will complete an End-of-Study Evaluation 12 weeks after endocrine therapy initiation to provide feedback about the study intervention.

Semi-structured interviews will be conducted with consenting members of the study teams and clinical teams at study sites with at least 2 patient participants, at least one of whom has passed the T2 survey time point and at least one of whom has had at least 1 alert for severe or worsening symptom(s). Semi-structured interviews will evaluate barriers and facilitators to implementation of the study intervention.

Conditions
Breast Cancer
Being tested
Outcomes4Me, Semi-structured interview
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Outcomes4MeOther

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

  • Semi-structured interviewOther

    Team member participants will complete a semi-structured interview.

Study groups in NCT05560685
Study groupRoleWhat they receive
Patient participantsOtherPatients 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.
Receives: Other: Outcomes4Me
Team Member ParticipantsOtherFeedback about the intervention will be obtained from patients and from members of the study teams and clinical teams caring for the patients who participate.
Receives: Other: Semi-structured interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 weeks

Secondary outcomes (2)

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

    Patient-reported baseline and treatment-emergent symptoms during the first 12 weeks of adjuvant endocrine therapy

    Measured: 12 Weeks

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

    Patient reported questionnaires will be completed to assess symptoms prior to treatment and 12 weeks after treatment start date.

    Measured: Baseline, 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start3 Oct 2022
  3. Primary completion6 May 2025
  4. Study completion6 May 2025

Why it stopped: Loss of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05560685
Sponsor's protocol ID
SIB2232
Other IDs
IRB00325375
Acronym
SMART-ER
Status last verified
Aug 2025
First submitted
16 Sep 2022
Last updated
12 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37733984

Questions about this trial

What is this clinical trial studying?

A study testing Outcomes4Me and Semi-structured interview in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 48 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Loss of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants using symptom monitoring survey (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05560685, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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