Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753673
• Other study ID #: 16-325
• Status: Completed
• Start date: April 20, 2016
• Est. completion date: April 13, 2020

Study information

• Verified date: April 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 13, 2020
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• qualitative interviews with patients

• questionnaires

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Hospital for Special Surgery, New York, McMaster University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center