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

NCT03333122 | Active Not Recruiting

• 1 other identifier: 11056
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

Breast Cancer Breast-Q; Breast Reconstruction; Breast Conserving Therapy; Mastectomy

Outcome Measures

Primary Outcomes (4)

• Compare health-related quality of life outcomes using condition specific surveys among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction

  The BREAST-Q survey is used to determine differences in health-related of life between treatment groups.

  Up to 5 Years

• Compare patient satisfaction with their treatment and result among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction

  The BREAST-Q survey is used to detect differences in patient satisfaction among the groups.

  Up to 5 Years

• Determine the effect of time on patient reported outcomes

  Survey responses will be compared across time.

  Up to 5 Years

• Patient satisfaction with breast cancer education and compare with source of information and socioeconomic status

  PS-CaTE survey is administered to assess patient satisfaction with breast cancer education.

  Up to 1 Year

Study Arms (3)

Breast Conserving Therapy

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

Mastectomy

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of adult female patients who are diagnosed with breast cancer will be recruited from the Multidisciplinary Clinic at Henry Ford Health System.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Study Officials

• Dunya Atisha, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: October 31, 2017
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)