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

The Ohio State University

Status

Completed

Conditions

Stage IIIA Breast Cancer

Stage IB Breast Cancer

Stage IIIB Breast Cancer

Stage IIB Breast Cancer

Stage IIA Breast Cancer

Stage IIIC Breast Cancer

Stage IA Breast Cancer

Stage 0 Breast Cancer

Treatments

Other: Survey Administration

Other: Laboratory Biomarker Analysis

Behavioral: Telephone-Based Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02400060

OSU-13252

NCI-2014-00809 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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