Breast HypertrophyNCT00149370
Quality of Life Among Breast Reduction Patients
An observational study of Breast Hypertrophy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Despite the growing evidence showing that breast hypertrophy is associated with reduced Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant positive impact on HRQL, there are unresolved issues that need to be addressed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Hypertrophy
- What is being tested?
- Breast reduction surgery
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2001to Aug 2003
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast hypertrophy
- Government approval for payment of reduction mammoplasty
Who cannot join
- Unable or unwilling to complete the quality of life questionnaires
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare / McMaster University
Hamilton, Ontario, L8N 4A6
About this study
Official title: A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
Despite the growing evidence showing that breast hypertrophy is associated with reduced Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant positive impact on HRQL, there are unresolved issues that need to be addressed. These include our ability to measure quantitatively the change that occurs after reduction and the ongoing restriction or denials of third party payments based on body mass index (BMI). The primary purpose of this study is to assess and measure the HRQL experienced by breast reduction patients using four reliable and validated HRQL measures.
Fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to participate in this prospective study. Participants completed the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO) instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire Appearance Assessment, and the Breast Related Symptom Questionnaire) at one week and one day pre-surgery and one, six, and 12 months post-surgery.
Read the detailed description
This study addresses the following questions of clinical and policy relevance: 1) Is the pre-surgery HRQL of these patients compromised and, if so, in which areas? 2) Do patients' HRQL improve after surgery and, if so, when and in which areas and by how much? 3) Is there a relationship between BMI and pre-/post-surgery changes in HRQL (i.e., is the pre/post effect similar for both obese and non-obese patients)? and 4) Is there a relationship between tissue re-section weight and pre-/post-surgery changes in HRQL (i.e., is the pre/post HRQL effect similar for patients having small and large amounts of tissue resected)?
- Conditions
- Breast Hypertrophy
- Being tested
- Breast reduction surgery
- Keywords
- breast hypertrophy, breast reduction surgery, health-related quality of life, Health Utilities Index, HUI, prospective, SF-36, quality-adjusted life years, QALY
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reduction surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2001
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast HypertrophyStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 52 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Achilleas Thoma, MD MSc FRCSC, Principal investigator, McMaster Univeristy / St. Joseph's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149370
- Sponsor's protocol ID
- 02-09-2005
- Status last verified
- Aug 2005
- First submitted
- 6 Sep 2005
- Last updated
- 8 Sep 2005
- Results posted
- No
Publications
Thoma A, Sprague S, Veltri K, Duku E, Furlong W. Methodology and measurement properties of health-related quality of life instruments: a prospective study of patients undergoing breast reduction surgery. Health Qual Life Outcomes. 2005 Jul 22;3:44. doi: 10.1186/1477-7525-3-44.
PubMed 16042775
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT00149370
- Acronym / sponsor ID
- 02-09-2005
- Conditions
- Breast Hypertrophy
- Keywords
- breast hypertrophy, breast reduction surgery, health-related quality of life, Health Utilities Index, HUI, prospective, SF-36, quality-adjusted life years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Aug 2003
- First posted
- 8 Sep 2005 (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.
Despite the growing evidence showing that breast hypertrophy is associated with reduced Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant positive impact on HRQL, there are unresolved issues that need to be addressed. These include our ability to measure quantitatively the change that occurs after reduction and the ongoing restriction or denials of third party payments based on body mass index (BMI). The primary purpose of this study is to assess and measure the HRQL experienced by breast reduction patients using four reliable and validated HRQL measures.
Fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to participate in this prospective study. Participants completed the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO) instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire Appearance Assessment, and the Breast Related Symptom Questionnaire) at one week and one day pre-surgery and one, six, and 12 months post-surgery.
Detailed description
This study addresses the following questions of clinical and policy relevance: 1) Is the pre-surgery HRQL of these patients compromised and, if so, in which areas? 2) Do patients' HRQL improve after surgery and, if so, when and in which areas and by how much? 3) Is there a relationship between BMI and pre-/post-surgery changes in HRQL (i.e., is the pre/post effect similar for both obese and non-obese patients)? and 4) Is there a relationship between tissue re-section weight and pre-/post-surgery changes in HRQL (i.e., is the pre/post HRQL effect similar for patients having small and large amounts of tissue resected)?
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of breast hypertrophy
- Government approval for payment of reduction mammoplasty
Key exclusion criteria (1 listed)
- Unable or unwilling to complete the quality of life questionnaires
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 |
|---|---|---|
| Breast reduction surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 8 Sep 2005.
- Results publication: PubMed 16042775Thoma A, Sprague S, Veltri K, Duku E, Furlong W. Methodology and measurement properties of health-related quality of life instruments: a prospective study of patients undergoing breast reduction surgery. Health Qual Life Outcomes. 2005 Jul 22;3:44. doi: 10.1186/1477-7525-3-44.
Related trials for Breast Hypertrophy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Improved Breast Enlargement Using the Subject's Own Fat Tissue
Breast Augmentation
Recruiting
ESPB Versus Intravenous Lidocaine for Pain After Mastopexy
Breast Hypertrophy
RecruitingObservational study
Prospective Study of EXErcise Regimens After Treatment for Breast Cancer for Hypertrophy and Conditioning
Cancer, Breast Cancer
Recruiting
EXERT-BC Protein: Protein Supplementation to Improve Body Composition After Treatment for Breast Cancer
Cancer, Breast Cancer
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.
Achilleas Thoma, MD MSc FRCSC principal investigator
McMaster Univeristy / St. Joseph's Healthcare
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 Hypertrophy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 2 inclusion and 1 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 8 Sep 2005. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00149370, which also lists 1 linked publication.
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 8 Sep 2005.