A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer

Thomas Jefferson University

Status: Active, not recruiting

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Progesterone Receptor Positive Tumor; Estrogen Receptor Positive Tumor

Treatments: Other: Text Message; Other: Questionnaire Administration; Other: Best Practice; Behavioral: Focus Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04086875

R01CA222246 (U.S. NIH Grant/Contract)

19F.265

Details and patient eligibility

About

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.

Enrollment: 332 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 3 patient groups

Phase 1 (focus groups)

Experimental group

Description:

Participants attend focus groups on adherence to hormone therapy.

Treatment:

Behavioral: Focus Group

Other: Questionnaire Administration

Phase II Group 1 (text messages)

Experimental group

Description:

Participants receive text messages twice weekly for 6 months to remind and motivate participants about AHT adherence.

Treatment:

Other: Questionnaire Administration

Other: Text Message

Phase II Group II (usual care)

Active Comparator group

Description:

Participants receive usual care.

Treatment:

Other: Best Practice

Other: Questionnaire Administration