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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: Clinical Trial NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Interventions
- OTHER Semi-structured interview
- OTHER Outcomes4Me
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2025-05-06 |
| Phase | NA |
Why NCT05560685 stopped before completion
NCT05560685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Semi-structured interview is the first listed.
NCT05560685 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05560685's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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