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Trial record 9 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborators:
Hospital for Special Surgery, New York
McMaster University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02753673
First received: April 22, 2016
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Breast Cancer Behavioral: qualitative interviews with patients Behavioral: questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Expectations of Breast Conserving Therapy: Broadening a Patient Reported Outcomes Instrument

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • measure patient expectations of breast-conserving therapy [ Time Frame: 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.


Estimated Enrollment: 30
Actual Study Start Date: April 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSKCC clinics
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02753673

Contacts
Contact: Andrea L Pusic, MD, MHS,FRCSC 646-888-3551
Contact: Mary L Gemignani, MD 646-888-5359

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrea L. Pusic, MD, MHS,FRCSC    646-888-3551      
Contact: Mary L Gemignani, MD    646-888-5359      
Principal Investigator: Andrea L Pusic, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Hospital for Special Surgery, New York
McMaster University
Investigators
Principal Investigator: Andrea L Pusic, MD, MHS,FRCSC Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02753673     History of Changes
Other Study ID Numbers: 16-325
Study First Received: April 22, 2016
Last Updated: May 15, 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast Conserving Therapy
Reported Outcomes Instrument
16-325

ClinicalTrials.gov processed this record on June 23, 2017