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

NCT ID: NCT03333122

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 575 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2030-01-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast Conserving Therapy

Patient who undergo breast conserving therapy or breast conserving therapy with oncoplastic therapies will complete the BREAST-Q Lumpectomy survey module.

No interventions assigned to this group

Mastectomy

Patients who undergo mastectomy will complete the BREAST-Q Mastectomy survey module.

No interventions assigned to this group

Mastectomy with Reconstruction

Patient who undergo breast reconstruction will complete the BREAST-Q Reconstruction survey module. This group will be further subdivided based on implant or autologous tissue reconstruction.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Dunya Atisha

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dunya Atisha, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

Other Identifiers

11056

Identifier Type: -

Identifier Source: org_study_id