Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients With Breast Cancer
NCT ID: NCT02400060
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2015-03-26
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Telephone-Based Intervention
Receive text messaging
Survey Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Telephone-Based Intervention
Receive text messaging
Survey Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Alliance for Clinical Trials in Oncology
OTHER
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Michelle Naughton
Principal Investigator
Principal Investigators
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Michelle Naughton, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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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
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2014-00809
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-13252
Identifier Type: -
Identifier Source: org_study_id
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