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Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02753673
Enrollment
22
Registered
2016-04-28
Start date
2016-04-20
Completion date
2020-04-13
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Conserving Therapy, Reported Outcomes Instrument, 16-325

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.

Interventions

BEHAVIORALqualitative interviews with patients
BEHAVIORALquestionnaires

Sponsors

Hospital for Special Surgery, New York
CollaboratorOTHER
McMaster University
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
measure patient expectations of breast-conserving therapy1 yearThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026