Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 253
- Locations
- 1
- Primary Endpoint
- Change in Functional Well-being
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Unable to read or comprehend English.
- •Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal cell or squamous cell cancer.
Arms & Interventions
Cohort A
Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to study activities.
Intervention: p16 tumor suppressor gene (Diagnostic Test)
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.
Intervention: Exercise Recall Patient Reported Outcomes (Behavioral)
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.
Intervention: Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes (Behavioral)
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.
Intervention: Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes (Behavioral)
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.
Intervention: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes (Behavioral)
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.
Intervention: Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a) (Behavioral)
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.
Intervention: Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) (Behavioral)
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.
Intervention: Patient Reported Outcomes PROMIS (Behavioral)
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.
Intervention: Patient Reported Outcomes FACT-Endocrine Symptoms (Behavioral)
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.
Intervention: Patient Reported Outcomes Penn Arthralgia Aging Survey (Behavioral)
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.
Intervention: Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE) (Behavioral)
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.
Intervention: p16 tumor suppressor gene (Diagnostic Test)
Outcomes
Primary Outcomes
Change in Functional Well-being
Time Frame: 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 Outcomes
- Comparison of Functional well-being- Cohort B(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 Fatigue-Cohort B(Pre-chemotherapy and 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 peripheral neuropathy-Cohort B(Pre-chemotherapy and at least 3 years after completion of chemotherapy)
- Changes in self-reported Fatigue-Cohort A(Pre-chemotherapy and at least 3 years after completion of chemotherapy)