Breast CancerNCT02753673
Developing a New Questionnaire About Patient Expectations of Breast Conserving Therapy
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- qualitative interviews with patients and questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2016to 13 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- 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
Who cannot join
- Inability to speak or understand English
- Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
- Patients undergoing lumpectomy without radiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Patient Expectations of Breast Conserving Therapy: Broadening a Patient Reported Outcomes Instrument
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
- Being tested
- qualitative interviews with patients, questionnaires
- Keywords
- Breast Conserving Therapy, Reported Outcomes Instrument, 16-325
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative interviews with patientsBehavioural
questionnairesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: qualitative interviews with patients; Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start20 Apr 2016
- Primary completion13 Apr 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York, McMaster University
- Responsible party
- Sponsor
- Investigators
- Andrea L Pusic, MD, MHS,FRCSC, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753673
- Sponsor's protocol ID
- 16-325
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2016
- Last updated
- 14 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Expectations of Breast Conserving Therapy: Broadening a Patient Reported Outcomes Instrument
- ClinicalTrials.gov ID
- NCT02753673
- Acronym / sponsor ID
- 16-325
- Conditions
- Breast Cancer
- Keywords
- Breast Conserving Therapy, Reported Outcomes Instrument, 16-325
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York, McMaster University
- Study start
- 20 Apr 2016 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Behavioral: qualitative interviews with patients, Behavioral: questionnairesThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to speak or understand English
- Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability
- Patients undergoing lumpectomy without radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative interviews with patients | Behavioural | Breast Cancer |
| questionnaires | Behavioural | Breast Cancer |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea L Pusic, MD, MHS,FRCSC principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure patient expectations of breast-conserving therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.