Clinical trial · Observational
Psychosocial Outcomes and Contralateral Prophylactic Mastectomy (CPM)
Treatment Decisions and Breast Cancer: Psychosocial Outcomes
NCT02263014CI-TRIAL-00113958active not recruitingResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Contralateral Prophylactic Mastectomy (CPM) Group
- description
- 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.
- interventionNames
- Behavioral: Questionnaires
- label
- No Contralateral Prophylactic Mastectomy (CPM) Group
- description
- 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.
- interventionNames
- Behavioral: Questionnaires
Primary outcomes (2)
- measure
- Psychosocial Outcomes of CPM Versus no CPM: Cancer Distress Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed ductal carcinoma in situ (DCIS) or Stage I-III sporadic unilateral invasive breast cancer 2. Age 18 or older 3. Able to speak, read, and write English. 4. Spouse/Partner: Married or living with patient for a year or more 5. Spouse/Partner: Age 18 or older 6. Spouse/Partner: Able to speak, read, and write English Exclusion Criteria: 1. Patients with previous breast cancer 2. Prior history of prophylactic mastectomy 3. 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
References
Publications (1)
- DERIVEDParker 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 30044695