Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02438449 |
| Other study ID # |
MSA-2015-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
April 2020 |
Study information
| Verified date |
February 2021 |
| Source |
McMaster University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
It is estimated that about 25% and 40% of health care expenditures in Canada and USA
respectively are wasted because of inefficiencies and not practicing evidence-based medicine.
As health care resources are scarce it behooves all of us to use these in a cost-effective
manner. The term "cost-effective" is used in the health care literature often but
erroneously. Investigators compare a "novel' intervention to a "prevailing" one and if the
novel intervention is less costly it is labeled "cost-effective". In a methodologically
correct cost-effectiveness study however, investigators need to integrate both the
effectiveness and costs of the competing interventions and calculate an incremental
cost-effective ratio. If this ratio falls within acceptability thresholds, the novel
intervention is labeled cost-effective. There are many techniques of breast reconstruction.
The two most common approaches are the Autologous Abdominal Tissue (AAT) and the Tissue
Expansion / Implant reconstructions. In this study these two most common breast
reconstruction approaches after mastectomy due to cancer performed in the
Hamilton/Niagara/Haldimand/Brant and Waterloo/Wellington LHINs will be investigated with a
cost-effectiveness analysis coupled with a methodologically robust observational study.
Description:
As a result of the recent advances in the treatment of breast cancer carried out by dedicated
researchers and made possible through breast cancer research, its mortality has been
gradually declining. Naturally, the quality of survivorship has taken an important role in
the last 3 decades. Unfortunately, for most women with breast cancer, their concerns about
survival are followed closely with concerns about body image, sexuality, self-esteem and
social life. Mastectomy, a mainstay in the treatment of breast cancer, is the primary cause
of these latter concerns. The investigators are therefore charged with looking at the disease
and the respective treatment of breast cancer holistically. Providing a comprehensive
management of breast cancer today requires attention to both oncologic principles and to the
patient's quality of life. A large part of the patient's quality of life comes from improved
reconstructive and aesthetic outcomes following mastectomy. In short, breast reconstruction
after mastectomy for cancer aims to improve body image and quality of life by reducing the
negative psychological impact of the deformity. Multiple techniques exist to accomplish this
goal. They include breast implants, autologous tissues, or occasionally, a combination
thereof. Although the ultimate goal is to recreate an aesthetically pleasing breast that
attempts to match the missing one, the decision to use a particular technique is
multi-factorial. It may be influenced by the surgeon's skills, the patient's preferences,
inherent contraindications with a patient, or the resources available in a particular
setting. Breast reconstructions can be costly to patients (indirect costs), third party
payers and society, especially as new technologies are introduced in clinical practice. In
the last 2 decades third party payers and governments in different jurisdictions have been
advocating for production of evidence that shows "value for money" germane to these different
procedures.Presently, the two most common approaches to breast reconstruction are the AAT
method and the TE/I method. These two approaches to breast reconstruction have yet to be
submitted to an economic evaluation using state-of-the-art cost-effectiveness analysis.
