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

Stage IIIA Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02400060
• Other study ID #: OSU-13252
• Secondary ID: NCI-2014-00809
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2014
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Stage 0 Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Intervention

Behavioral:
• Telephone-Based Intervention
Receive text messaging

Other:
• Survey Administration
Ancillary studies
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care-Medical Center	Burlington	Vermont
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Southeastern Medical Oncology Center-Goldsboro	Goldsboro	North Carolina
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Alliance for Clinical Trials in Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Patient and physician responses to the intervention and study participation	Descriptive statistics will be generated.	3 months

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