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
2 other identifiers
interventional
39
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedStudy Start
First participant enrolled
March 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJune 29, 2025
June 1, 2025
5.3 years
March 23, 2015
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Change in biomarkers
Baseline to 3 months
Patient and physician responses to the intervention and study participation
3 months
Study Arms (1)
Supportive (text messages and interactive exchanges)
EXPERIMENTALPatients receive daily text messages reminding them to take AHT and weekly interactive surveys delivered by a smart phone app for 3 months.
Interventions
Receive text messaging
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Fletcher Allen Health Care-Medical Center
Burlington, Vermont, 05401, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Naughton, PhD, MPH
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2015
First Posted
March 26, 2015
Study Start
March 26, 2015
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
June 29, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share