Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)
Treatment Decisions and Breast Cancer: Psychosocial Outcomes
2 other identifiers
observational
345
1 country
2
Brief Summary
The goal of this research study is to learn more about how different treatment decisions may influence the quality of life in women with breast cancer. Researchers want to use what is learned from this study to help future patients with breast cancer to be more informed when making treatment decisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedResults Posted
Study results publicly available
October 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
ExpectedNovember 26, 2025
November 1, 2025
2.6 years
October 8, 2014
March 14, 2017
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
Cancer-specific distress was measured with the Impact of Events Scale (IES) to assess 2 common categories of responses to stressful events: intrusion and avoidance. The IES scale consists of 15 items. For the intrusion category (7 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range is 0 to 35). For the avoidance category (8 items), participants are asked to rate the items on a 4 point scale: 0 (not at all), 1 (rarely), 3 (sometimes), and 5 (often) and the sum is the total score (complete range 0 to 40). The total cancer-specific distress score is the sum of the total intrusion score and the total avoidance score (complete range is 0 to 75). The total distress score was averaged for surveys completed at each time point. Higher mean scores indicate greater cancer-specific distress.
Baseline to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
Psychosocial Outcomes of CPM Versus no CPM: Satisfaction With Decision
The Satisfaction with Decision Scale (SWD) scale measures women's satisfaction with their surgery decision using the SWD six-item survey with a five-point scale where 1 is "strongly disagree" and 5 is "strongly agree" and the sum is the total score (complete range 6 to 30). The total satisfaction with decision score was averaged for surveys completed at each time point. Higher mean scores indicate greater satisfaction with the treatment decision.
One to 12 months post surgery, up to 18 months. Survey administered at 1, 6, 12 months following surgery.
Study Arms (2)
Contralateral Prophylactic Mastectomy (CPM) Group
Group of women who decide to have contralateral prophylactic mastectomy (CPM) along with scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after the surgery is completed.
No Contralateral Prophylactic Mastectomy (CPM) Group
Group of women who decide not to have contralateral prophylactic mastectomy (CPM) performed during scheduled mastectomy. Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, and 12 months after unilateral mastectomy or breast conserving surgery is completed.
Interventions
Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.
Eligibility Criteria
Breast cancer patients seen at University of Texas MD Anderson Cancer Center and at Kelsey Seybold Clinic.
You may qualify if:
- Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer
- Age 18 or older
- Able to speak, read, and write English.
- Spouse/Partner: Married or living with patient for a year or more
- Spouse/Partner: Age 18 or older
- Spouse/Partner: Able to speak, read, and write English
You may not qualify if:
- Patients with previous breast cancer
- Prior history of prophylactic mastectomy
- Known to have a germline gene mutation that predisposes them to an increased risk of breast cancer (e.g., BRCA1, BRCA2), and/or if they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kelsey-Seybold
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Parker PA, Peterson SK, Shen Y, Bedrosian I, Black DM, Thompson AM, Nelson JC, DeSnyder SM, Cook RL, Hunt KK, Volk RJ, Cantor SB, Dong W, Brewster AM. Prospective Study of Psychosocial Outcomes of Having Contralateral Prophylactic Mastectomy Among Women With Nonhereditary Breast Cancer. J Clin Oncol. 2018 Sep 1;36(25):2630-2638. doi: 10.1200/JCO.2018.78.6442. Epub 2018 Jul 25.
PMID: 30044695DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Abenaa Brewster, Professor, Clinical Cancer Prevention
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Abenaa M. Brewster, MD, MHS, BS
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 13, 2014
Study Start
February 24, 2014
Primary Completion
October 1, 2016
Study Completion (Estimated)
April 30, 2028
Last Updated
November 26, 2025
Results First Posted
October 5, 2020
Record last verified: 2025-11