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NCT05926024 · ClinicalTrials.gov registry record
Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
A clinical trial of Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- 253
- Enrollment target
- 1
- Study location
NCT05926024: Active study of Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05926024 is a study of Breast Cancer that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 253 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05926024, a study of Breast Cancer, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- 253 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates whether there are pre-treatment factors such as patient characteristics, specific breast cancer type, specific treatments, toxicities, or adverse events during treatment that may impact the quality of life and function, 3 years or more after the treatment, in cancer-free subjects. There will be 2 groups. Cohort A: Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consent for this study activities. Cohort B: Women with breast cancer, who did not receive chemotherapy, will be consented to be included in the study, and their electronic medical data will be used. Furthermore, the long-term effects of treatment and a biomarker of aging cyclin-dependent kinase inhibitor 2A (CDKN2A,p16INK4a) and relation will be assessed.
Primary Outcome
Change in Functional Well-being will be measured by FACT-G Functional Well-bein in participants who received chemotherapy (Cohort A). Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life and function measure developed and validated over 20 years ago that has been used in hundreds of cancer studies worldwide. It consists of four well-being domains -- physical, social/family, emotional, and functional. The FACT-G (Version 4) is a 27-item instrument that is formatted for s
Conditions Studied
Interventions
- BEHAVIORAL Exercise Recall Patient Reported Outcomes
- BEHAVIORAL Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes
- BEHAVIORAL Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes
- BEHAVIORAL Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes
- BEHAVIORAL Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2023-01-06 |
| Est. Completion | 2028-01-31 |
What the registry record for NCT05926024 still lists
NCT05926024 is an observational study that tracks outcomes without assigning an intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Exercise Recall Patient Reported Outcomes is the first listed.
NCT05926024 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05926024 about?
NCT05926024 is a clinical study titled "Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment". This study evaluates whether there are pre-treatment factors such as patient characteristics, specific breast cancer type, specific treatments, toxicities, or adverse events during treatment that may impact the quality of life and function, 3 years or more after the treatment, in cancer-free subject...
What is the current status of trial NCT05926024?
This trial is currently active not recruiting. The enrollment target is 253 participants. The study started on 2023-01-06. Estimated completion is 2028-01-31.
What conditions does trial NCT05926024 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05926024?
The interventions under investigation include: Exercise Recall Patient Reported Outcomes (BEHAVIORAL), Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes (BEHAVIORAL), Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes (BEHAVIORAL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes (BEHAVIORAL), Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05926024?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05926024 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05926024's enrollment target sits among peer trials
253 320th of 1224 higher than 904 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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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