Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

NCT02753673 | Completed

• 1 other identifier: 16-325
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Conserving Therapy; Reported Outcomes Instrument; 16-325

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Behavioral: qualitative interviews with patients; Behavioral: questionnaires

Interventions

qualitative interviews with patients BEHAVIORAL

Breast Cancer

questionnaires BEHAVIORAL

Breast Cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

You may qualify if:

• 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

You may not qualify if:

• Inability to speak or understand English
• Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
• Patients undergoing lumpectomy without radiation

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Hospital for Special Surgery, New York: collaborator
• McMaster University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andrea L Pusic, MD, MHS,FRCSC

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 28, 2016
• Study Start: April 20, 2016
• Primary Completion: April 13, 2020
• Study Completion: April 13, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

US (1)