Breast Cancer Clinical Trial

Assessment of Breast Cancer Patients Satisfaction and Health Related Quality of Life Outcomes

Summary

The purpose of the study is to learn more about the quality of life and satisfaction with breast cancer surgical treatment and education from patient reported outcome data. The data and information obtained from breast cancer patients can be invaluable in counselling patients with a new diagnosis of breast cancer on their expected outcomes and results. The hypothesis is that using prospectively obtained data to guide surgical decision-making and optimize access to surgical procedures would improve the treatment of patients and would most likely positively impact the health-related quality of life in patients.

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Full Description

This study will be a prospective observational study of women with newly diagnosed breast cancer. To date, there is little data in the literature assessing and comparing the outcomes associated with breast cancer surgical procedures. Information of satisfaction of patients with treatment, result, and breast cancer education they receive is particularly deficient. Therefore, breast cancer female patients will be recruited at Henry Ford Health System. Participants will voluntarily complete surveys electronically at specific points during their treatment and recovery process. Responses and satisfaction of quality of life will be collected and analyzed.

The BREAST-Q survey will be used to obtain patient reported outcomes.The surveys will be given preoperatively, at six months, one year, two years, and five years. Specific surveys will be given to the patients based on the treatment modality they receive.The groups are breast conserving therapy, mastectomy along, and mastectomy with reconstruction.The mastectomy with reconstruction group will be further subdivided based on implant or autologous tissue reconstruction. A survey adapted from the 'Patient Satisfaction with Cancer Treatment Education (PS-CaTE)' questionnaire will be administered at the preoperative and one year time point to evaluate satisfaction with their breast cancer education. PS-CaTE consists of two parts. Part one evaluates the patient's perception of the breast cancer education. Part two serves to elucidate the primary information sources the patients utilized by the patients. A demographic survey will also be given to patients preoperatively and postoperatively. Survey results will be analyzed to detect differences in health-related quality of life among the different treatments.

BREAST-Q surveys are health-related quality of life survey instruments developed to allow validated and reliable acquisition of patient reported outcomes.These surveys were meticulously crafted following internationally accepted guidelines as established by the Scientific Advisory Committee of the Medical Outcomes Trust and the U.S. Food and Drug Administration. The item list of this survey was developed from patient interviews, focus groups, expert panels, and literature review. Separate modules were developed for each treatment modality and include BREAST-Q Breast Conserving Therapy, BREAST-Q Mastectomy, BREAST-Q Reconstruction. These surveys have been used in major trials including the United Kingdom's National Health Service survey of 8,000 patients with mastectomy and mastectomy with reconstruction and FDA surveillance and longitudinal follow-up of patients with silicone breast implants.

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Eligibility Criteria

Inclusion Criteria:

Patients having surgery for breast cancer
Treatment must be performed within the Henry Ford Health System
Patients must be at least 18 years of age

Exclusion Criteria:

Male gender
Patients with non-operative management of breast cancer
Patients who are unable to complete the surveys, either by choice or because of limited English, Spanish, or Arabic proficiency
Patients who are unable to complete a preoperative survey
Patients with Stage IV or metastatic disease

Study is for people with:

Breast Cancer

Estimated Enrollment:

2940

Study ID:

NCT03333122

Recruitment Status:

Recruiting

Sponsor:

Henry Ford Health System

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There is 1 Location for this study

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Henry Ford Health System
Detroit Michigan, 48202, United States More Info
Wing Lee Cheung
Contact
313-916-1074
[email protected]
Dunya Atisha, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

2940

Study ID:

NCT03333122

Recruitment Status:

Recruiting

Sponsor:


Henry Ford Health System

How clear is this clinincal trial information?

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