Purpose

Adjuvant endocrine hormonal therapy (EHT) is highly effective and appropriate for nearly all breast cancer patients with hormone receptor-positive tumors, which represent 75% of all breast cancer diagnoses. Long-term use of EHT reduces cancer recurrence rates and cuts the risk of death nearly in half during the second decade after diagnosis, research shows. Despite the proven benefits, about 33% of women who are prescribed EHT do not take their medication as prescribed (less than 80% take their daily dosage) and are thus at higher risk of recurrence and death.

This educational randomized controlled study will develop and pilot-test a bilingual, culturally tailored, personalized, interactive mobile application (app) in combination with patient navigation to promote and improve adherence to endocrine hormonal therapy (EHT) among breast cancer patients.

Category

IRB Number
20160245HU
NCT Number
NCT02850939
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Local Recruitment Point of Contact
Patricia Chalela
+1 (210) 562-6513
chalela@uthscsa.edu

Local Recruitment Point of Contact
Vivian Cortez
(210) 567-0836
cortezv1@uthscsa.edu

Principal Investigator
Amelie Ramirez

Regulatory Point of Contact
Jessica Alcaraz
alcarazj@uthscsa.edu

Regulatory Point of Contact
Patricia Chalela
+1 (210) 562-6513
chalela@uthscsa.edu

Regulatory Point of Contact
Vivian Cortez
(210) 567-0836
cortezv1@uthscsa.edu

Regulatory Point of Contact
Anna Moreno
(210) 567-0836
morenoa3@uthscsa.edu

Regulatory Point of Contact
Amelie Ramirez
(210) 562-6500
ramirezag@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

    • English and Spanish speaking adult patients, 18 years of age and older who: a) are diagnosed with hormone receptor-positive breast cancer and prescribed endocrine hormonal treatment (EHT); b) own a cell phone, are able to send and receive text message and access the internet; and c) are able to provide informed consent to participate in the study.

Exclusion Criteria

    • Patients who: (a) are unable to provide consent due to a mental, emotional, or physical handicap, that keep them from understanding the consent information; (b) do not own a smart phone; (c) are unable to respond to text messages and questions or unable download the study app; d) are unable to see the app and study materials and videos (i.e., are blind, deaf)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)
Condition
  • Breast Cancer
  • Arm Groups

    ArmDescriptionIntervention
    No Intervention

    Usual care

    Patients assigned to the control (usual care) group (60) will receive the usual EHT care and materials offered at the MCC's breast clinic.
    Experimental

    Mobile phone app + patient navigation

    Patients assigned to the intervention group (60) will: 1) use the personalized mobile phone app in their preferred language for a duration of 6 months; and 2) receive assistance from a patient navigator. They will also continue to receive the usual EHT care provided at the MCC's breast clinic.
  • Behavioral: Mobile phone app + patient navigation

    The intervention group will receive two components: 1) a culturally sensitive, personalized and easy to use smartphone app; and 2) support from a patient navigator. The intervention is based in Social Cognitive Theory and principles of motivational interviewing - and will feature basic components of individual empowerment, motivation and engagement, including knowledge, attitudes, skills, peer modeling, social support/reinforcement and self-efficacy beliefs and expectations