Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions
This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.
PRIMARY OBJECTIVES: I. Compare endocrine therapy (ET) adherence at 12 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care. SECONDARY OBJECTIVES: l. Compare endocrine therapy (ET) adherence at 24 months in diverse women exposed to text message reminders (TMR)-only, telephone-based motivational interviewing counseling (MI)-only, or both (TMR+MI), versus usual care. OUTLINE: Patients are randomized to 1 of 4 arms. ARM I (TMR): Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months. ARM II (MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals. ARM III (TMR + MI): Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II. ARM IV (ENHANCED USUAL CARE): Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer. After completion of study participation, patients are followed up for up to 24 months. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05673200 -
Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer
|
Phase 1 | |
Active, not recruiting |
NCT03218826 -
PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT04535323 -
Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer
|
Phase 1 | |
Recruiting |
NCT05464810 -
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
|
Early Phase 1 | |
Active, not recruiting |
NCT04249622 -
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT03666819 -
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
|
Phase 2 | |
Not yet recruiting |
NCT05930483 -
Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT04862585 -
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
|
Phase 2/Phase 3 | |
Withdrawn |
NCT05967286 -
Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
|
Phase 2 | |
Recruiting |
NCT04593277 -
Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study
|
N/A | |
Active, not recruiting |
NCT05086731 -
Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer
|
N/A | |
Recruiting |
NCT05368428 -
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
|
N/A | |
Recruiting |
NCT04673448 -
Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
Not yet recruiting |
NCT05539365 -
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04086875 -
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
|
N/A | |
Completed |
NCT00507923 -
Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer
|
N/A | |
Recruiting |
NCT06058377 -
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
|
Phase 3 | |
Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
Recruiting |
NCT05455658 -
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05674578 -
Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors
|
N/A |