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

Plain-language summary

This observational study provides long-term follow-up of women who completed primary treatment for early breast cancer at least three years ago, assessing patient-reported outcomes such as quality of life, fatigue, and cognitive function. It includes women aged 21 and over with no breast cancer recurrence or metastasis. It is a study without an assigned phase and is active but not currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

UNC Lineberger Comprehensive Cancer Center

Intervention

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

Start date

1/6/2023

Estimated completion

1/31/2028

Countries

United States

Related genes

Locations

• Chapel Hill, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.