Trial Outcomes & Findings for Tumor: Breast Ratio Study (NCT NCT02216136)

Last Updated: 2019-08-02

Results Overview

The Breast Q is a comprehensive and specific quality of life instrument that allows for patient self-assessment prior to and following breast surgery. Comprised of quality of life and satisfaction domains, and generates domain-specific Q-scores (0-100) constructed using Rasch analysis. The higher the score, the more satisfied the participant was. -Collected preoperatively (no more than 3 months prior to surgery) and postoperatively (approximately 6 months after conclusion of radiotherapy in the Breast Conservation Cohort and \>=3 months after the final balancing reconstructive intervention in the Mastectomy and Reconstruction Cohort.

Recruitment status

COMPLETED

Target enrollment

162 participants

Primary outcome timeframe

Compare preoperative values with postoperative values (up to 4 years)

Results posted on

2019-08-02

Participant Flow

Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction

Participant milestones

Participant milestones
Measure	Breast Conservation Cohort Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.	Mastectomy and Reconstruction Cohort Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.
Overall Study STARTED	72	90
Overall Study COMPLETED	72	90
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tumor: Breast Ratio Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Conservation Cohort n=72 Participants Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.	Mastectomy and Reconstruction Cohort n=90 Participants Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.	Mastectomy Only Cohort Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.	Total n=162 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 8.8 • n=93 Participants	54.7 years STANDARD_DEVIATION 10.5 • n=4 Participants	—	54.6 years STANDARD_DEVIATION 25.9 • n=483 Participants
Sex: Female, Male Female	72 Participants n=93 Participants	90 Participants n=4 Participants	—	162 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=93 Participants	4 Participants n=4 Participants	—	9 Participants n=483 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	—	6 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants	4 Participants n=4 Participants	—	8 Participants n=483 Participants
Race (NIH/OMB) White	58 Participants n=93 Participants	79 Participants n=4 Participants	—	137 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	—	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	—	2 Participants n=483 Participants
Region of Enrollment United States	72 participants n=93 Participants	90 participants n=4 Participants	—	162 participants n=483 Participants

PRIMARY outcome

Timeframe: Compare preoperative values with postoperative values (up to 4 years)

Population: -Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction

Outcome measures

Outcome measures
Measure	Breast Conservation Cohort n=72 Participants Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment.	Mastectomy and Reconstruction Cohort n=90 Participants Mastectomy and Reconstruction group: This group will have mastectomy with immediate reconstruction (defined as reconstruction process starting at time of initial mastectomy surgery). They may or may not require chemotherapy and radiation depending on their cancer staging as well as multiple steps of their breast reconstruction.	Mastectomy Only Cohort Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation.
Quality of Life as Measured by the Breast Q Satisfaction with breasts (preop)	61.9 score on a scale Standard Deviation 20.4	57.6 score on a scale Standard Deviation 17.1	—
Quality of Life as Measured by the Breast Q Psychosocial well-being (preop)	68.6 score on a scale Standard Deviation 16.0	66.8 score on a scale Standard Deviation 14.6	—
Quality of Life as Measured by the Breast Q Psychosocial well-being (postop)	81.4 score on a scale Standard Deviation 21.7	72.6 score on a scale Standard Deviation 18.6	—
Quality of Life as Measured by the Breast Q Sexual well-being (preop))	62.4 score on a scale Standard Deviation 20	57.5 score on a scale Standard Deviation 19.4	—
Quality of Life as Measured by the Breast Q Satisfaction with breasts (postop)	74.2 score on a scale Standard Deviation 19.8	64.2 score on a scale Standard Deviation 16.8	—
Quality of Life as Measured by the Breast Q Sexual-well being (postop)	64.5 score on a scale Standard Deviation 15.8	54.4 score on a scale Standard Deviation 20.4	—

Adverse Events

Breast Conservation Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mastectomy and Reconstruction Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mastectomy Only Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Terence M. Myckatyn, M.D.

Washington University School of Medicine

Phone: 314-996-3873

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place