TERMINATED

SMART-ER: Symptom Monitoring With Patient-reported Outcomes

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-10-03

Study Completion:2025-05-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05560685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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. * 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.	* 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

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.
* 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.

* 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

Contacts and Locations

Principal Investigator

Jenni Sheng, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Sibley Memorial Hospital

Washington, District of Columbia, 20016

United States

Johns Hopkins

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Jenni Sheng, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-03

Study Completion Date2025-05-06

Study Record Updates

Study Start Date2022-10-03

Study Completion Date2025-05-06

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer