This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04086875.
PRIMARY OBJECTIVE:
I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.
SECONDARY OBJECTIVE:
I. Conduct mediator analyses of intervention efficacy..
EXPLORATORY OBJECTIVE:
I. Explore whether age (=< 45 versus [vs.] > 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress.
OUTLINE:
PHASE I: Patients attend focus groups on adherence to hormone therapy.
PHASE II: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence.
GROUP II: Patients receive usual care.
PHASE III: Patients complete an interview on study.
After completion of study, patients are followed up at 3, 6, and 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorKuang-Yi Wen
