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NCT04852471 · ClinicalTrials.gov registry record · NA
Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging
A NA study of Gynecologic Cancer, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT04852471: Completed NA study of Gynecologic Cancer, sponsored by University of Michigan Rogel Cancer Center.
NCT04852471 is a NA study of Gynecologic Cancer that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 102 participants, below the 763-participant average among 55 other Gynecologic Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04852471, a NA study of Gynecologic Cancer, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message survey, a pre-programmed, automated response will be sent from the study prompting the patient to take specific actions (or no action if no symptoms). Investigators will assess whether this method improves patients' well-being as compared to the current standard of care for patients. Currently, after surgery, patients are provided counseling and written instructions when they leave the hospital on how to care for themselves at home. If the patient has questions or concerns, they contact their care team. The optimal way to help patients assess their own symptoms at home remains unknown. Investigators are also assessing if using the symptom survey reduces readmissions to the hospital.
Primary Outcome
The mean total score on the FACT-G will be compared between the two arms. The FACT-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. The minimally important difference (MID) is 5 points for the FACT-G questionnaire. In other words, five points is the most minimal differe
Conditions Studied
Interventions
- BEHAVIORAL Standard Post-Operative Counseling + FACT-G
- BEHAVIORAL PROM symptom tracker
Study Locations (1)
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2022-01-05 |
| Est. Completion | 2023-05-02 |
| Phase | NA |
What the finished NCT04852471 record still lists
NCT04852471 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 763-participant average among 55 other Gynecologic Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Gynecologic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Standard Post-Operative Counseling + FACT-G is the first listed.
NCT04852471 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04852471 about?
NCT04852471 is a clinical study titled "Improving Quality of Life Using Patient Reported Outcomes Measures Post-operative Via Text Messaging". This study is investigating a new way to monitor patients who are recovering at home after surgery. This study uses text messages to ask patients to review their own symptoms and then reply with the level of severity of specific symptoms. Based on each patient's specific response to the text message...
What is the current status of trial NCT04852471?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2022-01-05. Estimated completion is 2023-05-02.
What conditions does trial NCT04852471 study?
This clinical trial studies the following conditions: Gynecologic Cancer.
What interventions are being tested in trial NCT04852471?
The interventions under investigation include: Standard Post-Operative Counseling + FACT-G (BEHAVIORAL), PROM symptom tracker (BEHAVIORAL).
Who is sponsoring clinical trial NCT04852471?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04852471 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04852471's enrollment target sits among peer trials
102 18th of 55 higher than 37 of 55 other Gynecologic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gynecologic Cancer 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.
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