Breast Cancer Clinical Trial
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer
Summary
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.
Full Description
PRIMARY OBJECTIVES:
I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.
SECONDARY OBJECTIVES:
I. Conduct mediator analyses of intervention efficacy..
EXPLORATORY OBJECTIVES:
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: Participants attend focus groups on adherence to hormone therapy.
PHASE II: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence.
GROUP II: Participants receive usual care.
After completion of study, participants are followed up at 3, 6, and 12 months.
Eligibility Criteria
Inclusion Criteria:
Woman diagnosed with stage I-III breast cancer (BCa).
Hormone receptor positive tumor.
Completed local definitive treatment (i.e., surgery chemotherapy, radiation).
Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen.
At least 12 months of AHT recommended.
Able to read and understand English.
Able to provide informed consent.
Have a mobile device with text (TXT) capability.
Know or willing to learn how to use TXT.
Exclusion Criteria:
• Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
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There are 7 Locations for this study
Philadelphia Pennsylvania, 19107, United States More Info
Philadelphia Pennsylvania, 19114, United States More Info
Philadelphia Pennsylvania, 19148, United States More Info
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