COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-03-26
Study Completion:2020-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT02400060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eligible women are those who:
  2. * Are post-menopausal, verified by:
  3. * Post bilateral surgical oophorectomy; or
  4. * No spontaneous menses \>= 1 year; or
  5. * No menses for \< 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
  6. * Are diagnosed with primary breast cancer (BC) (stages I-III)
  7. * Eligible to receive AHT (tamoxifen or an aromatase inhibitors \[AI\]) for the first time
  8. * Completed all primary treatment
  9. * Own a smartphone (in order to receive text messages and utilize the phone app)
  10. * Agree to receive text messages on their smartphone over a 3-month period
  11. * Provide consent and permission to review their medical records
  12. * Plan to stay in the study area for 3 months
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Michelle Naughton, PhD, MPH
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

  • Michelle Naughton, PhD, MPH, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-03-26
Study Completion Date2020-06-30

Study Record Updates

Study Start Date2015-03-26
Study Completion Date2020-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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
  • Stage 0 Breast Cancer