Clinical trial NCT02400060: Telephone-Based Intervention in Increasing Adherence to Adjuvant Hormonal Therapy in Patients with Breast Cancer
Official title: Increasing Adherence to Adjuvant Hormonal Therapy Among Breast Cancer Patients: Phase 2 - Pilot Test of Intervention for Feasibility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Alliance for Clinical Trials in Oncology
First posted: 2015-03-26
Enrollment: 314
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Optimal usage of AHT (includes initiation, continuation and adherence)
timeFrame: Up to 3 months
measure: Acceptance assessed via medical records of receiving a prescription for AHT and filling it
timeFrame: Up to 3 months
measure: Continuation assessed via self-report of taking at least one dose per week
timeFrame: Up to 3 months
measure: Adherence assessed via self-report of taking the prescribed dose at least 6 of 7 days per week
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change in biomarkers
timeFrame: Baseline to 3 months
measure: Patient and physician responses to the intervention and study participation
timeFrame: 3 months
Other outcomes:
Locations:
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center-Goldsboro
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Burlington
country: United States
facility: Fletcher Allen Health Care-Medical Center
state: Vermont
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Michelle Naughton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: