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NCT05755347 · ClinicalTrials.gov registry record
Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer
A clinical trial, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- 50
- Enrollment target
NCT05755347: Completed study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05755347 is a clinical trial that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05755347 has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
The purpose of this single-site non-randomized study is to identify areas of need related to functional status and overall health, including nutrition and mental health in subjects with metastatic breast cancer (MBC). A decline in functional status is observed after breast cancer diagnosis and exacerbated by treatment. Declining functional status impacts the quality of life and can lead to increased comorbidity burden, hospitalization, and increased mortality. Functional status is assessed by specific provider-graded scales. Patient Reported Outcome (PRO) measures may better assess certain aspects of patient health and symptom domains. Thus, potentially supporting the future implementation of effective prehabilitation strategies. This study explores whether a PRO-based survey will identify the physical and emotional health and the social and financial status of patients newly diagnosed with MBC.
Primary Outcome
Physical activity levels will be measured using the Godin Leisure-Time Exercise Questionnaire. Godin Leisure-Time Exercise Questionnaire has 3 dichotomous questions, answers will be "yes" or "no". There will be reason questions if the answer is no.
Interventions
- OTHER General health survey questionnaires
- OTHER PROMIS Cancer Function Brief 3D profile questionnaires
- OTHER FACT-G questionnaires
- OTHER Godin Leisure-Time Exercise Questionnaire
- OTHER REAP-S questionnaires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2024-02-05 |
What the finished NCT05755347 record still lists
NCT05755347 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which General health survey questionnaires is the first listed.
NCT05755347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05755347 about?
NCT05755347 is a clinical study titled "Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer". The purpose of this single-site non-randomized study is to identify areas of need related to functional status and overall health, including nutrition and mental health in subjects with metastatic breast cancer (MBC). A decline in functional status is observed after breast cancer diagnosis and exace...
What is the current status of trial NCT05755347?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2023-03-17. Estimated completion is 2024-02-05.
What interventions are being tested in trial NCT05755347?
The interventions under investigation include: General health survey questionnaires (OTHER), PROMIS Cancer Function Brief 3D profile questionnaires (OTHER), FACT-G questionnaires (OTHER), Godin Leisure-Time Exercise Questionnaire (OTHER), REAP-S questionnaires (OTHER).
Who is sponsoring clinical trial NCT05755347?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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