Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Nov 21, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how pain levels reported by women undergoing treatment for breast cancer might differ based on age. Specifically, the study will compare whether younger women (aged 18 and older) report more pain or more intense pain while receiving a medication called pegfilgrastim, which helps prevent low white blood cell counts during chemotherapy. If you decide to participate, it won't change how your cancer treatment is planned or delivered.

To be eligible for this study, you must be a woman aged 18 or older, diagnosed with invasive breast cancer, and scheduled to receive chemotherapy along with pegfilgrastim. You should also be able to read and understand English or Spanish. Participants will be asked to report their pain levels throughout their chemotherapy treatment, helping researchers understand the relationship between age and pain during this process. If you have certain medical conditions or a history of severe pain, you may not be able to join the study.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• Subject must meet all the following applicable inclusion criteria to participate in this study:
• • 1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• • 2. Age ≥ 18 years at the time of consent
• • 3. Female
• • 4. Histological or cytological confirmation of invasive breast cancer.
• • 5. Planned to undergo adjuvant or neoadjuvant chemotherapy treatment for invasive breast cancer AND pegfilgrastim (or biosimilar substitution) treatment for neutropenic prophylaxis.
• • 6. Ability to read and understand the English and/or Spanish language
• • 7. As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study
• • Exclusion Criteria
• Subjects meeting any of the criteria below may not participate in the study:
• • 1. Uncontrolled intercurrent illness/medical condition or psychiatric illness/social situations that would limit compliance with study requirements as determined by the investigator
• • 2. Have previously received chemotherapy or radiation other than the first cycle of the planned adjuvant or neoadjuvant chemotherapy as indicated in Inclusion #5
• • 3. Taking chronic narcotics, as determined by treating physician
• • 4. Diagnosis of distant metastatic breast cancer
• • 5. Diagnosis of a chronic pain syndrome (e.g. fibromyalgia, severe osteoarthritis, etc.)
• • 6. A baseline ESAS pain score of greater than 8.