Breast Cancer, DCIS, LCIS
Conditions
Keywords
Mastectomy, Breast Cancer, Reconstruction, Lumpectomy, Breast Conservation Therapy
Brief summary
This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.
Interventions
None listed
Sponsors
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Patient must be scheduled to undergo breast conservation therapy (BCT), mastectomy or mastectomy with immediate reconstruction (defined as initiating the reconstructive process at time of mastectomy) for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB). Stage IIB tumors are 2-5 cm with micrometastases 0.2 to 2.0 cm in lymph nodes; or 2-5 cm tumor with 1-3 positive axillary or internal mammary lymph nodes, or \>5 cm with no lymph node involvement. Clinical staging, based on imaging and physical exam will be used for enrollment. Patients that are upstaged due to unexpected findings at the time of surgery/assessment of surgical pathology will be excluded at that time. For staging reference please see http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2#keypoint13 * If multifocal/multicentric disease of the ipsilateral breast is encountered and patients are still deemed eligible for BCT or mastectomy per standard of care, then the tumor area will be calculated as the total volumes of the identified foci. * Patient must be between 18-72 years old * Patient must be able to understand and willing to sign a written informed consent document
Exclusion criteria
* Cognitive impairment * History of radiation to the chest wall or breasts * Patients unable to undergo MRI due to metallic implant or claustrophobia * Patients that are pregnant since breast MRI is contraindicated * History of previous breast surgery other than primary cosmetic augmentation or breast reduction * Identification of a concurrent or synchronous contralateral cancer during the enrollment period * Any patient that would not have been considered for BCT or reconstruction * BCT patients planning to proceed with reconstruction during their study participation timeline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by the Breast Q | Compare preoperative values with postoperative values (up to 4 years) | 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. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Breast Conservation Cohort Breast Conservation group with newly diagnosed breast cancer who decide to proceed with lumpectomy and radiation treatment. | 72 |
| 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. | 90 |
| Mastectomy Only Cohort Mastectomy Only Cohort: This group will have mastectomy without reconstruction. They may or may not require chemotherapy and radiation. | 0 |
| Total | 162 |
Baseline characteristics
| Characteristic | Breast Conservation Cohort | Total | Mastectomy and Reconstruction Cohort |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 8.8 | 54.6 years STANDARD_DEVIATION 25.9 | 54.7 years STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 58 Participants | 137 Participants | 79 Participants |
| Region of Enrollment United States | 72 participants | 162 participants | 90 participants |
| Sex: Female, Male Female | 72 Participants | 162 Participants | 90 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Quality of Life as Measured by the Breast Q
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast Conservation Cohort | Quality of Life as Measured by the Breast Q | Sexual well-being (preop)) | 62.4 score on a scale | Standard Deviation 20 |
| Breast Conservation Cohort | Quality of Life as Measured by the Breast Q | Psychosocial well-being (preop) | 68.6 score on a scale | Standard Deviation 16 |
| Breast Conservation Cohort | Quality of Life as Measured by the Breast Q | Psychosocial well-being (postop) | 81.4 score on a scale | Standard Deviation 21.7 |
| Breast Conservation Cohort | Quality of Life as Measured by the Breast Q | Sexual-well being (postop) | 64.5 score on a scale | Standard Deviation 15.8 |
| Breast Conservation Cohort | Quality of Life as Measured by the Breast Q | Satisfaction with breasts (preop) | 61.9 score on a scale | Standard Deviation 20.4 |
| Breast Conservation Cohort | Quality of Life as Measured by the Breast Q | Satisfaction with breasts (postop) | 74.2 score on a scale | Standard Deviation 19.8 |
| Mastectomy and Reconstruction Cohort | Quality of Life as Measured by the Breast Q | Satisfaction with breasts (preop) | 57.6 score on a scale | Standard Deviation 17.1 |
| Mastectomy and Reconstruction Cohort | Quality of Life as Measured by the Breast Q | Sexual-well being (postop) | 54.4 score on a scale | Standard Deviation 20.4 |
| Mastectomy and Reconstruction Cohort | Quality of Life as Measured by the Breast Q | Psychosocial well-being (preop) | 66.8 score on a scale | Standard Deviation 14.6 |
| Mastectomy and Reconstruction Cohort | Quality of Life as Measured by the Breast Q | Satisfaction with breasts (postop) | 64.2 score on a scale | Standard Deviation 16.8 |
| Mastectomy and Reconstruction Cohort | Quality of Life as Measured by the Breast Q | Psychosocial well-being (postop) | 72.6 score on a scale | Standard Deviation 18.6 |
| Mastectomy and Reconstruction Cohort | Quality of Life as Measured by the Breast Q | Sexual well-being (preop)) | 57.5 score on a scale | Standard Deviation 19.4 |