Assessment of Breast Cancer Patients Satisfaction and Health Related Quality of Life Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/21/2019 |
| Start Date: | October 31, 2017 |
| End Date: | October 2027 |
| Contact: | Wing Lee Cheung |
| Email: | wcheung1@hfhs.org |
| Phone: | 313-916-1074 |
Prospective Evaluation of Patient Reported Outcomes and Satisfaction With Education in Breast Cancer Patients (PROS)
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.
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.
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.
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.
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
We found this trial at
1
site
Detroit, Michigan 48202
Principal Investigator: Dunya Atisha, MD
Phone: 313-916-1074
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