Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy
April 13, 2020 updated by: Memorial Sloan Kettering Cancer Center
Patient Expectations of Breast Conserving Therapy: Broadening a Patient Reported Outcomes Instrument
The purpose of this study is to develop a questionnaire to measure patient expectations of breast-conserving therapy (breast-conserving surgery and radiation).
This questionnaire will assist both surgeons and patients by helping provide valuable information to patients about what to expect during and after surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
22
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
MSKCC clinics
Description
Inclusion Criteria:
- Female
- Age 18-75
- Patients who are scheduled to undergo lumpectomy at MSKCC as part of breast conserving therapy for invasive breast cancer OR who have completed BCT (lumpectomy and radiation) at least 6 months prior to recruitment
Exclusion Criteria:
- Inability to speak or understand English
- Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
- Patients undergoing lumpectomy without radiation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast Cancer
The assessments are all qualitative.
The assessments include an in-person, open-ended qualitative interview, during which the interviewer will use an interview guide to ensure that all relevant topics are discussed.
Participants will also complete the Patient Expectations with Breast Reconstruction questionnaire using the think-aloud technique in order to identify which questions reflect the expectations of BCT patients, which questions need modification to reflect the expectations of BCT patients and which questions are not appropriate for BCT patients.
The responses to the expectations questionnaire for this portion of the interview will not be recorded or analyzed; only the participants' thoughts and opinions about the questions will be recorded.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measure patient expectations of breast-conserving therapy
Time Frame: 1 year
|
This study aims to develop the Patient Expectations with Breast-Conserving Therapy questionnaire.
New questionnaire content will be generated using qualitative research methods.
Interview data will be analyzed using a grounded theory approach, which involves generating codes, categories, and themes inductively, rather than imposing a priori assumptions or classifications on the data.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea L Pusic, MD, MHS,FRCSC, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2016
Primary Completion (Actual)
April 13, 2020
Study Completion (Actual)
April 13, 2020
Study Registration Dates
First Submitted
April 22, 2016
First Submitted That Met QC Criteria
April 25, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 13, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 16-325
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.