Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
- Conditions
- Breast Cancer
- Registration Number
- NCT05926024
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 253
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.
- Unable to read or comprehend English.
- Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal cell or squamous cell cancer.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Functional Well-being At least 3 years after completion of chemotherapy 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.
- Secondary Outcome Measures
Name Time Method Comparison of Functional well-being- Cohort B At least 3 years after completion of chemotherapy Comparison of Functional well-being will be measured as a comparison of FACT-G Functional Well-being scores of participants who received chemotherapy (Cohort A)and participant who did not receive chemotherapy (Cohort B).
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.Changes in self-reported cognition- Cohort B Pre-chemotherapy and at least 3 years after completion of chemotherapy Changes in self-reported cognition will be assessed using PROMIS Cognitive Function (Short Form 8a), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort B group (participants did not receive chemotherapy).
PROMIS Cognitive Function (Short Form 8a) This measure 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.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 will be assessed using Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort A group (participants who received chemotherapy).
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. The increasing score reflects worse neuropathy.Changes in self-reported Fatigue-Cohort B Pre-chemotherapy and at least 3 years after completion of chemotherapy Changes in self-reported Fatigue will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort B group (participants did not receive chemotherapy).
Functional Assessment of Chronic Illness Therapy-Fatigue (TFACIT-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".Changes in self-reported cognition-Cohort A Pre-chemotherapy and at least 3 years after completion of chemotherapy Changes in self-reported cognition will be assessed using PROMIS Cognitive Function (Short Form 8a), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort A group (participants who received chemotherapy).
PROMIS Cognitive Function (Short Form 8a) This measure 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.Changes in self-reported peripheral neuropathy-Cohort B Pre-chemotherapy and at least 3 years after completion of chemotherapy Changes in self-reported peripheral neuropathy will be assessed using Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12), between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort B group (participants did not receive chemotherapy).
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. The increasing score reflects worse neuropathy.Changes in self-reported Fatigue-Cohort A Pre-chemotherapy and at least 3 years after completion of chemotherapy Changes in self-reported Fatigue will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) between pre-chemotherapy and at least 3 years after completion of chemotherapy in the Cohort A group (participants who received chemotherapy).
Functional Assessment of Chronic Illness Therapy-Fatigue (TFACIT-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".
Trial Locations
- Locations (1)
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of North Carolina🇺🇸Chapel Hill, North Carolina, United States