Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment

UNC Lineberger Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Behavioral: Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE); Behavioral: Exercise Recall Patient Reported Outcomes; Behavioral: Patient Reported Outcomes PROMIS; Behavioral: Patient Reported Outcomes FACT-Endocrine Symptoms; Behavioral: Patient Reported Outcomes Penn Arthralgia Aging Survey; Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes; Behavioral: Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes; Diagnostic Test: p16 tumor suppressor gene; Behavioral: Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12); Behavioral: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes; Behavioral: Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)

Study type: Observational

Funder types: Other

Identifiers

NCT05926024

LCCC2229

Details and patient eligibility

About

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.

Enrollment: 253 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Informed consent was obtained per Institutional Review Board guidelines to participate in the study and HIPAA authorization for the release of personal health information.
2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
3. Age ≥21 years at the time of consent.
4. Able to read and comprehend English.
5. No breast cancer recurrence or metastasis; no other cancer diagnosis other than basal cell or squamous cell cancers.

Exclusion criteria

1. Unable to read or comprehend English.
2. Breast cancer recurrence or metastasis; any other cancer diagnosis other than basal cell or squamous cell cancer.

Trial design

253 participants in 2 patient groups

Cohort A

Description:

Women who participated in previous studies namely NCT02167932, NCT02328313, and NCT03761706, will be re-contacted and consented to study activities.

Treatment:

Diagnostic Test: p16 tumor suppressor gene

Cohort B

Description:

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.

Treatment:

Behavioral: Patient Reported Outcomes PROMIS Cognitive Function (Short Form 8a)

Behavioral: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Patient Reported Outcomes

Behavioral: Patient Reported Outcomes Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12)

Diagnostic Test: p16 tumor suppressor gene

Behavioral: Health Behavior Questionnaire (HBQ)30 Patient Reported Outcomes

Behavioral: Patient Reported Outcomes Penn Arthralgia Aging Survey

Behavioral: Functional Assessment of Cancer Therapy-General (FACT-G) Patient Reported Outcomes

Behavioral: Patient Reported Outcomes FACT-Endocrine Symptoms

Behavioral: Patient Reported Outcomes PROMIS

Behavioral: Exercise Recall Patient Reported Outcomes

Behavioral: Patient Reported Outcomes PRO-CTCAE (patient-reported CTCAE)