Lobular Breast Carcinoma In Situ Clinical Trial
Official title:
Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care (MiChoice)
This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.
PRIMARY OBJECTIVE: I. To compare the frequency of chemoprevention informed choice at 6 months after registration among women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between the intervention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standard educational materials) and control (standard educational materials alone) arms. SECONDARY OBJECTIVES: I. To assess patient chemoprevention knowledge, chemoprevention intention/decision, perceived breast cancer risk and worry, accuracy of breast cancer risk perception, decision conflict and decision regret at baseline, 6 months, and 12 months in the intervention and control arms. II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) annually for up to 5 years between the intervention and control arms. III. To assess shared decision-making about chemoprevention among patients and healthcare providers after their 6-month clinic visit in the intervention and control arms. IMPLEMENTATION OBJECTIVE: I. To assess the implementation of the decision support tools, RealRisks and BNAV, into clinic workflow, and to better understand barriers and facilitators to chemoprevention usage by conducting telephone/video-conference interviews of healthcare providers and high-risk women with AH or LCIS assigned to the active intervention. OUTLINE: Recruitment centers are randomized to 1 of 2 groups. GROUP I (CONTROL): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. GROUP II (INTERVENTION): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the electronic health record (EHR). A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual. After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02314156 -
Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
|
Phase 2 | |
| Completed |
NCT01874184 -
Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT01905046 -
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
|
Phase 3 | |
| Completed |
NCT01869764 -
Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
|
Phase 2 | |
| Terminated |
NCT01754519 -
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
|
Phase 2 | |
| Completed |
NCT01849250 -
Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors
|
Phase 2 | |
| Completed |
NCT01819233 -
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy
|
N/A | |
| Completed |
NCT01077453 -
Letrozole in Preventing Breast Cancer in Healthy Postmenopausal Women at High Risk for Breast Cancer
|
Phase 1 | |
| Completed |
NCT01723943 -
Educational Counseling in Improving Communication and Quality of Life in Spouses and Breast Cancer Patients
|
N/A | |
| Completed |
NCT00637481 -
A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer
|
Phase 1 | |
| Completed |
NCT01975363 -
Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT01706432 -
Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer
|
||
| Completed |
NCT01219075 -
Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer
|
N/A | |
| Withdrawn |
NCT01729832 -
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
|
N/A | |
| Completed |
NCT02961790 -
Oxybutynin Chloride in Managing Hot Flashes
|
Phase 3 | |
| Active, not recruiting |
NCT02515110 -
Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer
|
N/A | |
| Active, not recruiting |
NCT01293032 -
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
|
N/A |