Clinical trial · Observational
Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer
A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer
NCT01399359CI-TRIAL-00054280completedClinicalTrials.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)
RATIONALE: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk. PURPOSE: This clinical trial studies factors influencing decision-making about the use of chemoprevention in women at increased risk for breast cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counseling session | Behavioral | — | UNRESOLVED |
| online questionnaire | Other | — | UNRESOLVED |
| Questionnaire 1 | Other | — | UNRESOLVED |
| Questionnaire 2 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Women who decide not to take a SERM
- description
- Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire.
- interventionNames
- Behavioral: Counseling session
- Other: Questionnaire 1
- Other: Questionnaire 2
- Other: online questionnaire
- label
- Women who decide to take a SERM
- description
- Women participate in the counseling session, questionnaire 1 and questionnaire 2.
- interventionNames
- Behavioral: Counseling session
- Other: Questionnaire 1
- Other: Questionnaire 2
Primary outcomes (1)
- measure
- Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion criteria * The participant must be female. * The participant must be greater than or equal to 35 years of age. * The participant must be English-speaking. * The participant must have been identified as being at increased risk for breast cancer as determined by the doctor/healthcare professional (HCP) . (Increased risk for breast cancer does not have to be based on a Gail score.) * During the participant's counseling session, breast cancer risk and the use of SERMs for breast cancer risk reduction must have been discussed, as reported by the doctor/HCP who conducted the session. Note: This criterion does not apply to participants who are asked before the counseling session to participate in the video recording component of DMP-1 at the selected NSABP sites. Exclusion criteria * Previous invasive breast cancer of any type. * Previous history of ductal carcinoma in situ (DCIS). * Previous history of lobular carcinoma in situ (LCIS) if treated with mastectomy, radiation therapy, or endocrine therapy. * Participation in any other cancer prevention study involving pharmacologic intervention(s) or osteoporosis prevention study involving pharmacologic intervention(s). * Any history of or current tamoxifen, raloxifene, or other SERM therapy for any reason. (Participants are eligible if SERM use has been discussed prior to the counseling session as long as SERMs were never used.)
References
Publications (2)
- DERIVEDBlakeslee SB, Gunn CM, Parker PA, Fagerlin A, Battaglia T, Bevers TB, Bandos H, McCaskill-Stevens W, Kennedy JW, Holmberg C. Talking numbers: how women and providers use risk scores during and after risk counseling - a qualitative investigation from the NRG Oncology/NSABP DMP-1 study. BMJ Open. 2023 Nov 19;13(11):e073138. doi: 10.1136/bmjopen-2023-073138. PMID 37984961
- DERIVEDGunn CM, Bokhour BG, Parker VA, Battaglia TA, Parker PA, Fagerlin A, McCaskill-Stevens W, Bandos H, Blakeslee SB, Holmberg C. Understanding Decision Making about Breast Cancer Prevention in Action: The Intersection of Perceived Risk, Perceived Control, and Social Context: NRG Oncology/NSABP DMP-1. Med Decis Making. 2019 Apr;39(3):217-227. doi: 10.1177/0272989X19827258. Epub 2019 Feb 25. PMID 30803311