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NCT02400060 | RECRUITING | Stage IA Breast Cancer

Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients with Breast Cancer
Sponsor:

Ohio State University Comprehensive Cancer Center

Information provided by (Responsible Party):

Michelle Naughton

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.

Condition or disease

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

Intervention/treatment

Telephone-Based Intervention

Survey Administration

Laboratory Biomarker Analysis

Phase

NA

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
Estimated Enrollment : 314 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility
Actual Study Start Date : 2015-03-26
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients with Breast Cancer

Location Details

NCT02400060

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ACTIVE NOT RECRUITING

United States, North Carolina

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States, 27534

ACTIVE NOT RECRUITING

United States, North Carolina

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States, 27157

RECRUITING

United States, Ohio

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

ACTIVE NOT RECRUITING

United States, Vermont

Fletcher Allen Health Care-Medical Center

Burlington, Vermont, United States, 05401