Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: qualitative interviews with patients; Behavioral: questionnaires

• Registration Number: NCT02753673
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-20
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Status Verified: 2020-04
• Primary Completion: 2020-04-13
• Study Completion: 2020-04-13
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer	questionnaires	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.
Breast Cancer	qualitative interviews with patients	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.

Primary Outcome Measures

Name	Time	Method
measure patient expectations of breast-conserving therapy	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States