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Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Primary Purpose

Breast Cancer, Malignant Neoplasm of Breast

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Breast Reconstruction
Delayed Breast Reconstruction
Breast-Q questionnaire
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Reconstruction, Mastectomy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
  • Subjects must be breast reconstruction candidates using implant based breast reconstruction.
  • Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior breast cancer surgical treatment
  • Prior breast reconstruction
  • Inability to provide written consent

Sites / Locations

  • Cleveland Clinic, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immediate breast reconstruction

Delayed breast reconstruction

Arm Description

The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.

Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.

Outcomes

Primary Outcome Measures

optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
Proportion of patients preferring delayed reconstruction.

Secondary Outcome Measures

Major complications
defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).
Minor complications
defined as the ones that were office treated, not requiring a reoperation
Number of revision surgeries
defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal
Hospital cost of the complete reconstruction treatment
Cost of reconstruction including the cost of complications
Change in patient satisfaction
Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up

Full Information

First Posted
July 19, 2017
Last Updated
May 16, 2022
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03261323
Brief Title
Breast Reconstruction Following Breast Cancer in Very High Risk Patients
Official Title
Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
insufficient staff
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to: Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications
Detailed Description
Primary Endpoint(s) Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort Compare immediate and delayed reconstruction outcome metrics through retrospective review Secondary Endpoint(s) Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction. Compare complications and reoperations between immediate versus delayed reconstruction. Compare the hospital costs between immediate versus delayed reconstruction Evaluate the effectiveness of risk reduction strategies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Malignant Neoplasm of Breast
Keywords
Breast Reconstruction, Mastectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate breast reconstruction
Arm Type
Active Comparator
Arm Description
The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
Arm Title
Delayed breast reconstruction
Arm Type
Experimental
Arm Description
Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
Intervention Type
Procedure
Intervention Name(s)
Immediate Breast Reconstruction
Intervention Description
Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.
Intervention Type
Procedure
Intervention Name(s)
Delayed Breast Reconstruction
Intervention Description
Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.
Intervention Type
Other
Intervention Name(s)
Breast-Q questionnaire
Intervention Description
Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment
Primary Outcome Measure Information:
Title
optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
Description
Proportion of patients preferring delayed reconstruction.
Time Frame
Until 1 year post breast reconstruction
Secondary Outcome Measure Information:
Title
Major complications
Description
defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).
Time Frame
Until 1 year post breast reconstruction
Title
Minor complications
Description
defined as the ones that were office treated, not requiring a reoperation
Time Frame
Until 1 year post breast reconstruction
Title
Number of revision surgeries
Description
defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal
Time Frame
Until 1 year post breast reconstruction
Title
Hospital cost of the complete reconstruction treatment
Description
Cost of reconstruction including the cost of complications
Time Frame
Until 1 year post breast reconstruction
Title
Change in patient satisfaction
Description
Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up
Time Frame
Until 1 year post breast reconstruction
Other Pre-specified Outcome Measures:
Title
Aesthetic evaluation
Description
Aesthetic evaluation using postoperative photos one year after the first surgery, and after the final reconstruction surgery
Time Frame
Until 1 year post breast reconstruction

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy. Subjects must be breast reconstruction candidates using implant based breast reconstruction. Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Prior breast cancer surgical treatment Prior breast reconstruction Inability to provide written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Risal Djohan, MD
Organizational Affiliation
Cleveland Clinic, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Breast Reconstruction Following Breast Cancer in Very High Risk Patients

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