Breast CancerNCT00605670
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery
An observational study of Breast Cancer and Breast Surgery, run by Memorial Sloan Kettering Cancer Center at 5 sites in 2 countries.
Trial summary
The goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer, Breast Surgery, Breast Reconstruction
- What is being tested?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 722 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2005to Nov 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinics at the various sites
Who may be able to join
- All stages (1-4)
- Age > or = to 18 to 85 years.
- Postoperative Group: Male and Female patients who have undergone mastectomy, breast reconstruction, reduction, augmentation, bariatric or body contouring surgery between 1 month to 8 years ago
- Or
- Preoperative Group: Male and Female patients who are scheduled to undergo mastectomy, breast reconstruction, reduction, or augmentation or body contouring surgery
Who cannot join
- Inability to speak or understand English
- Active psychiatric illness, cognitive or sensory impairment
- Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
John Hopkins Medical Center
Baltimore, Maryland, 21287
Dartmouth Medical Center
Lebanon, New Hampshire
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
About this study
Official title: Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument
The goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results. We hope that such a questionnaire will improve the understanding of breast surgery results and patient care.
- Conditions
- Breast Cancer, Breast Surgery, Breast Reconstruction, Breast Reduction, Breast Augmentation
- Being tested
- questionnaires
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
patients will fill out two questionnaires post surgery
questionnairesBehavioural
Patient will fill out questionnaire before and 3 to 6 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Postoperative Breast Surgery Patients Receives: Behavioral: questionnaires | |
| 2 | Preoperative Breast Surgery Patients Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and validate a new patient derived measure of satisfaction with breast surgery.
Measured: conclusion of study
Secondary outcomes (1)
Determining variations in satisfaction related to patient characteristics and preoperative expectations.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJun 2005
- Primary completionNov 2013
- Study completionNov 2013
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
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University College, London, Dartmouth-Hitchcock Medical Center, University of British Columbia, Johns Hopkins University, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Andrea Pusic, M.D., M.H.S., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605670
- Sponsor's protocol ID
- 05-058
- Status last verified
- Nov 2013
- First submitted
- 11 Jan 2008
- Last updated
- 14 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument
- ClinicalTrials.gov ID
- NCT00605670
- Acronym / sponsor ID
- 05-058
- Conditions
- Breast Cancer, Breast Surgery, Breast Reconstruction, Breast Reduction, Breast Augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- McMaster University, University College, London, Dartmouth-Hitchcock Medical Center, University of British Columbia, Johns Hopkins University, University of Pittsburgh
- Study start
- Jun 2005
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Jan 2008 (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 goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results. We hope that such a questionnaire will improve the understanding of breast surgery results and patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: questionnairesPostoperative Breast Surgery Patients |
| 2 | – | Behavioral: questionnairesPreoperative Breast Surgery Patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinics at the various sites
Key inclusion criteria (5 listed)
- All stages (1-4)
- Age > or = to 18 to 85 years.
- Postoperative Group: Male and Female patients who have undergone mastectomy, breast reconstruction, reduction, augmentation, bariatric or body contouring surgery between 1 month to 8 years ago
- Or
- Preoperative Group: Male and Female patients who are scheduled to undergo mastectomy, breast reconstruction, reduction, or augmentation or body contouring surgery
Key exclusion criteria (3 listed)
- Inability to speak or understand English
- Active psychiatric illness, cognitive or sensory impairment
- Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions
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 |
|---|---|---|
| questionnairespatients will fill out two questionnaires post surgery | Behavioural | 1 |
| questionnairesPatient will fill out questionnaire before and 3 to 6 months after treatment. | Behavioural | 2 |
Primary outcome
To develop and validate a new patient derived measure of satisfaction with breast surgery.
Time frame: conclusion of study
1 secondary outcome
Determining variations in satisfaction related to patient characteristics and preoperative expectations.
Time frame: conclusion of study
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 Nov 2013.
- 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 Pusic, M.D., M.H.S. principal investigator
Memorial Sloan Kettering Cancer Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Surgery, run by Memorial Sloan Kettering Cancer Center at 5 sites in 2 countries.
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 5 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 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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?
To develop and validate a new patient derived measure of satisfaction with breast surgery. (time frame: conclusion of study). 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 Nov 2013.