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NCT05560685 · ClinicalTrials.gov registry record · NA

SMART-ER: Symptom Monitoring With Patient-reported Outcomes

A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Terminated
Registry status
NA
Development phase
10
Enrollment target

NCT05560685 is a NA study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 10 participants.

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The verdict

NCT05560685, a NA study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

TERMINATED
Registry status
NA
Development phase
10 participants
Enrollment target

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.

Interventions

  • OTHER Semi-structured interview
  • OTHER Outcomes4Me

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2022-10-03
Est. Completion 2025-05-06
Phase NA

What the Registry Record Tells You About NCT05560685

The ClinicalTrials.gov registry entry for NCT05560685 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Semi-structured interview is the first listed.

NCT05560685 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05560685 about?

NCT05560685 is a clinical study titled "SMART-ER: Symptom Monitoring With Patient-reported Outcomes". 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 endoc...

What is the current status of trial NCT05560685?

This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2022-10-03. Estimated completion is 2025-05-06.

What interventions are being tested in trial NCT05560685?

The interventions under investigation include: Semi-structured interview (OTHER), Outcomes4Me (OTHER).

Who is sponsoring clinical trial NCT05560685?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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