Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

NCT ID: NCT02753673

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-20

Study Completion Date

2020-04-13

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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

qualitative interviews with patients

Intervention Type BEHAVIORAL

questionnaires

Intervention Type BEHAVIORAL

Interventions

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qualitative interviews with patients

Intervention Type BEHAVIORAL

questionnaires

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea L Pusic, MD, MHS,FRCSC

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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16-325

Identifier Type: -

Identifier Source: org_study_id

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