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

Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology Center-Goldsboro
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care-Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive (text messages and interactive exchanges); Patients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Survey Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Receive text messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal usage of AHT (includes initiation, continuation and adherence)	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.	Up to 3 months
Acceptance assessed via medical records of receiving a prescription for AHT and filling it	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.	Up to 3 months
Continuation assessed via self-report of taking at least one dose per week	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.	Up to 3 months
Adherence assessed via self-report of taking the prescribed dose at least 6 of 7 days per week	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.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in biomarkers	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.	Baseline to 3 months
Patient and physician responses to the intervention and study participation	Descriptive statistics will be generated.	3 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Alliance for Clinical Trials in Oncology
• Investigators: Principal Investigator: Michelle Naughton, PhD, MPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2015
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimated): March 26, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Carcinoma; Carcinoma in Situ; Breast Carcinoma In Situ; Breast Neoplasms
• Other Study ID Numbers: OSU-13252; NCI-2014-00809 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No