Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients with Breast Cancer

Not Applicable

Recruiting

• Conditions: Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIIC Breast Cancer; Stage IIB Breast Cancer; Stage 0 Breast Cancer; Stage IIA Breast Cancer
• Interventions: Behavioral: Telephone-Based Intervention; Other: Survey Administration; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02400060
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This pilot trial studies a telephone-based intervention to see if it increases adherence to adjuvant hormonal therapy in patients with breast cancer. Increasing communication between doctors and patients with breast cancer may help patients to better follow recommendations on taking adjuvant hormonal treatment medication. A telephone-based intervention may help to increase doctor-patient communication and patients' adherence to their prescribed medication.

Detailed Description

PRIMARY OBJECTIVES:

I. Pilot test intervention effects on adherence to adjuvant hormonal therapy (AHT) and explore trends in the adherence outcomes by demographic and psychosocial factors defined as acceptance, continuation, and adherence.

SECONDARY OBJECTIVES:

I. Feasibility of study design defined as recruitment rate, rate of using intervention as instructed, rate of protocol completion, and completion of psycho-social questionnaires which have been associated with adherence to AHT in the existing literature (i.e., depression, social support, pain, stress, fatigue, quality of life, pill taking attitude and behavior, perceived risk of breast cancer recurrence).

TERTIARY OBJECTIVES:

I. Surveying patients and physicians regarding their comments on the intervention components (i.e., video, text messaging, and app \[application\]) and overall study participation.

OUTLINE:

Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-23
• Study Start: 2015-03-26
• Study First Posted: 2015-03-26
• Status Verified: 2024-06
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 314

Inclusion Criteria

• Eligible women are those who:

  • Are post-menopausal, verified by:

    • Post bilateral surgical oophorectomy; or
    • No spontaneous menses >= 1 year; or
    • No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards

• Are diagnosed with primary breast cancer (BC) (stages I-III)

• Eligible to receive AHT (tamoxifen or an aromatase inhibitors [AI]) for the first time

• Completed all primary treatment

• Own a smartphone (in order to receive text messages and utilize the phone app)

• Agree to receive text messages on their smartphone over a 3-month period

• Provide consent and permission to review their medical records

• Plan to stay in the study area for 3 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive (text messages and interactive exchanges)	Telephone-Based Intervention	Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.
Supportive (text messages and interactive exchanges)	Survey Administration	Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.
Supportive (text messages and interactive exchanges)	Laboratory Biomarker Analysis	Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.

Primary Outcome Measures

Name	Time	Method
Acceptance assessed via medical records of receiving a prescription for AHT and filling it	Up to 3 months	Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.
Adherence assessed via self-report of taking the prescribed dose at least 6 of 7 days per week	Up to 3 months	Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance. Weekly compliance (number of days reported taking medication) via the text messaging system will be examined longitudinally to assess whether a change over time was observed.
Optimal usage of AHT (includes initiation, continuation and adherence)	Up to 3 months	Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.
Continuation assessed via self-report of taking at least one dose per week	Up to 3 months	Descriptive statistics will be generated. Confidence intervals (95%) for the outcomes will be generated using the Clopper-Pearson method. Logistic regression will be used to explore whether any trends are observed in the outcomes by demographic or psychosocial factors. Mediation analyses will be conducted to determine if any of the psychosocial measures are mediators of compliance.

Secondary Outcome Measures

Name	Time	Method
Change in biomarkers	Baseline to 3 months	Comparisons (correlations, bivariate plots) will be made between the biomarkers and self-reported rates of usage to explore the feasibility of using a biomarker to measure optimal usage in future studies.
Patient and physician responses to the intervention and study participation	3 months	Descriptive statistics will be generated.

Trial Locations

Locations (4)

Southeastern Medical Oncology Center-Goldsboro; 🇺🇸 Goldsboro, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

Fletcher Allen Health Care-Medical Center; 🇺🇸 Burlington, Vermont, United States