Clinical trial NCT02438449: Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study
Official title: A Cost-Effectiveness Analysis Comparing Abdominal-based Autogenous Tissue (AAT) and Tissue Expander- Implant (TE/I) Reconstruction of the Breast After Mastectomy- A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast reconstruction
mastectomy
health-related quality of life
Health Utilities Index
HUI
prospective
quality-adjusted life years
QALY
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
First posted: 2015-05-08
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients undergoing breast reconstruction after mastectomy on one or both breasts being seen by one of the participating plastic surgeons. If patients qualify for the trial according to the inclusion and exclusion criteria, they will be invited to participate in the study and will be required to provide written informed consent.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years of age or older.
2. Patients undergoing breast reconstruction (immediate or delayed) after mastectomy procedure on one or both breasts.
3. Eligible for two step tissue expander and implant based procedure, or one of the following autogenous abdomen tissue-based procedures (pedicled TRAM flap, Free TRAM, ms TRAM flap, DIEP flap, SIEA flap, Rubens flap).

Exclusion Criteria:

1. Patients who have had previous breast reconstruction surgery.
2. Patients undergoing other procedures during reconstruction surgery, other than the mastectomy itself in the case of immediate or delayed reconstruction.
3. Patients unable to complete the questionnaires due to language barriers.
4. Geographic inaccessibility or inability to adhere to study protocol requirements.

Primary outcomes:
measure: Health-related Quality of Life (utilities and disease-specific)
timeFrame: 1 year
Secondary outcomes:
measure: Healthcare resource utilization including out-of-pocket expenses by patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare / McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Achilleas Thoma, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References: