Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
1 other identifier
observational
253
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2023
CompletedFirst Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
March 11, 2026
March 1, 2026
5.1 years
June 21, 2023
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Functional Well-being
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 self-administration and uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". It takes 6-8 minutes for an average patient to complete.
At least 3 years after completion of chemotherapy
Secondary Outcomes (7)
Comparison of Functional well-being- Cohort B
At least 3 years after completion of chemotherapy
Changes in self-reported cognition-Cohort A
Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported cognition- Cohort B
Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported peripheral neuropathy-Cohort A
Pre-chemotherapy and at least 3 years after completion of chemotherapy
Changes in self-reported peripheral neuropathy-Cohort B
Pre-chemotherapy and at least 3 years after completion of chemotherapy
- +2 more secondary outcomes
Study Arms (2)
Cohort A
Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to 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.
Interventions
Questionnaire items inquire about (1) the number of days of the week participants engage in walking for pleasure or exercise and (2) the number of minutes per day that participants engage in walking for pleasure or exercise. The same two questions are repeated pertaining to exercise in general. Completion of these items takes 1 minute to complete.
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 self-administration and uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". It takes 6-8 minutes for an average patient to complete.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item scale that uses a 5-point Likert-type scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The recall period is "during the past 7 days". This measure takes about 1 minute to complete.
PROMIS Cognitive Function (Short Form 8a) includes 8 items on a 5-point Likert-type scale ranging from very often/several times a day = 1 to never = 5, with higher scores indicating greater perceived loss of cognitive function. This measure takes less than 1 minute to complete.
Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) is a questionnaire that includes 12 items inquiring about symptoms in the past 7 days (0=not at all to 4=very much) pertaining to numbness or tingling in hands/feet, discomfort in hands/feet, joint pain or muscle cramps, weakness all over, trouble hearing, ringing/buzzing in ears, buttoning buttons, trouble feeling the shape of small objects in hands, trouble walking, and pain in hands/feet in cold temperatures. This measure takes about t 1 minute to complete.
PROMIS Measures Global Health (10 items), Anxiety (6 items), Depression (8 items), and Stress (10 items). All items are on a 5-point Likert-type scale form never to very often. Completion of all 34 items should take no more than 3 minutes to complete.
FACT-Endocrine Symptom is a 19-item questionnaire inquiring about hot flashes, cold sweats, night sweats; vaginal discharge, itching/irritation, bleeding or spotting, dryness; pain or discomfort with intercourse, loss of interest in sex; weight gain; lightheadedness; vomiting; diarrhea; headaches; bloating; breast sensitivity/tenderness; mood swings; irritability; pain in joints. Responses are on a 5- point Likert-type scale from not at all to very much. This measure takes about two minutes to complete.
Penn Arthralgia Aging Survey is an 8-item scale inquiring about joint pain, with a 4-point response scale from not at all to complete. Items pertaining to slowing down, stopping, being hesitant, unable to do this, and feeling unusually aged. This measure takes less than a minute to complete.
PRO-CTCAE (patient-reported CTCAE) is Patients will be asked about the side effects of chemotherapy treatment at baseline, every 3 weeks during chemotherapy, at the end of chemotherapy, and at 6 months post-chemotherapy. Patients are asked to rate "in the past 7 days" the average severity, frequency, and intensity and a scale from 1=none/never/not at all to 5=very severe/very much/almost all of the time. Symptom list: Abdominal pain, Constipation, Diarrhea. Mucositis oral, Nausea, Vomiting, Edema limbs, Fatigue, Pain, Arthralgia, Myalgia, Peripheral sensory neuropathy, Anxiety, Depression, Insomnia, Dyspnea, Rash maculopapular, Hot flashes. Completion of these measures takes 5 minutes for an average patient
Blood samples will be obtained to test the p16 tumor suppressor gene from the subjects It is voluntary..
Health Behavior Questionnaire (HBQ)30 -- Questionnaire items pertain to the history of smoking, engagement in vigorous physical activity, alcohol consumption, and mortality status of parents, and take less than 1 minute to complete.
Eligibility Criteria
Women have been diagnosed with breast cancer and cancer-free for equal or more than 3 years.
You may qualify if:
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- Informed consent was obtained per Institutional Review Board guidelines to participate in the study and HIPAA authorization for the release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥21 years at the time of consent.
- Able to read and comprehend English.
- No breast cancer recurrence or metastasis; no other cancer diagnosis other than basal cell or squamous cell cancers.
You may not qualify if:
- Unable to read or comprehend English.
- Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal cell or squamous cell cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Related Links
Biospecimen
A blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyman Muss, MD
UNC Lineberger Comprehensive Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2023
First Posted
July 3, 2023
Study Start
January 6, 2023
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share