Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Exercise Recall Patient Reported OutcomesBehavioral: Health Behavior Questionnaire (HBQ)30 Patient Reported OutcomesBehavioral: Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported OutcomesBehavioral: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported OutcomesBehavioral: 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 PROMISBehavioral: Patient Reported Outcomes FACT-Endocrine SymptomsBehavioral: Patient Reported Outcomes Penn Arthralgia Aging SurveyBehavioral: Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE)Diagnostic Test: p16 tumor suppressor gene
- 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
- Arm && Interventions
Group Intervention Description Cohort B p16 tumor suppressor gene 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. Cohort B Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes 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. Cohort B Exercise Recall Patient Reported Outcomes 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. Cohort B Patient Reported Outcomes PROMIS 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. Cohort B Patient Reported Outcomes FACT-Endocrine Symptoms 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. Cohort B Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes 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. Cohort B Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes 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. Cohort B Patient Reported Outcomes Penn Arthralgia Aging Survey 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. Cohort B Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE) 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. Cohort B Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a) 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. Cohort A p16 tumor suppressor gene Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to study activities. Cohort B Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) 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.
- 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