Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment (NCT05926024)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of North Carolina — Chapel Hill, North Carolina
Age range: 21 Years
🧪 Interventions in This Study
- 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)
- Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) (BEHAVIORAL)
- Patient Reported Outcomes PROMIS (BEHAVIORAL)
- Patient Reported Outcomes FACT-Endocrine Symptoms (BEHAVIORAL)
- Patient Reported Outcomes Penn Arthralgia Aging Survey (BEHAVIORAL)
- Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE) (BEHAVIORAL)
- p16 tumor suppressor gene (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of North Carolina — Chapel Hill, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.