Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Patient Expectations of Breast Conserving Therapy: Broadening a Patient Reported Outcomes Instrument

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: qualitative interviews with patients
* Behavioral: questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer<br>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. | Behavioral: qualitative interviews with patients<br> <br> Behavioral: questionnaires<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure patient expectations of breast-conserving therapy | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Conserving Therapy, Reported Outcomes Instrument, 16-325