Breast Cancer FemaleNCT03333122
Assessment of Breast Cancer Patients Satisfaction and Health Related Quality of Life Outcomes
An observational study of Breast Cancer Female, run by Henry Ford Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- How many people
- 575 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2017to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- Breast Cancer Breast-Q, Breast Reconstruction, Breast Conserving Therapy, Mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 Years
Determine the effect of time on patient reported outcomes
Survey responses will be compared across time.
Measured: 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.
Measured: Up to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start31 Oct 2017
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunya Atisha, Henry Ford Health System
- Investigators
- Dunya Atisha, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333122
- Sponsor's protocol ID
- 11056
- Status last verified
- May 2025
- First submitted
- 30 Oct 2017
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Patient Reported Outcomes and Satisfaction With Education in Breast Cancer Patients (PROS)
- ClinicalTrials.gov ID
- NCT03333122
- Acronym / sponsor ID
- 11056
- Conditions
- Breast Cancer Female
- Keywords
- Breast Cancer Breast-Q, Breast Reconstruction, Breast Conserving Therapy, Mastectomy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare health-related quality of life outcomes using condition specific surveys among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction
Time frame: Up to 5 Years
The BREAST-Q survey is used to determine differences in health-related of life between treatment groups.
Compare patient satisfaction with their treatment and result among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction
Time frame: Up to 5 Years
The BREAST-Q survey is used to detect differences in patient satisfaction among the groups.
Determine the effect of time on patient reported outcomes
Time frame: Up to 5 Years
Survey responses will be compared across time.
Patient satisfaction with breast cancer education and compare with source of information and socioeconomic status
Time frame: Up to 1 Year
PS-CaTE survey is administered to assess patient satisfaction with breast cancer education.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dunya Atisha, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare health-related quality of life outcomes using condition specific surveys among women undergoing breast conserving therapy, mastectomy alone, or mastectomy with reconstruction (time frame: Up to 5 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.