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SMART-ER: Symptom Monitoring With Patient-reported Outcomes

NCT05560685 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-12

No results posted yet for this study

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

Interventions

OTHER

Outcomes4Me

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

OTHER

Semi-structured interview

Team member participants will complete a semi-structured interview.

Sponsors & Collaborators

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • Outcomes4Me

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Jenni Sheng, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2025-05-06
Completion
2025-05-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560685 on ClinicalTrials.gov