This phase I trial studies how well the LifeExtend-AI smartphone application works in improving medication adherence in stage I-III breast cancer survivors who are receiving aromatase inhibitors (AIs). LifeExtend-AI is a mobile-health phone application that may improve self-reported symptoms, promote life-saving medication compliance, and encourage healthy lifestyle behaviors in stage I-III breast cancer survivors receiving AIs.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04170920.
PRIMARY OBJECTIVE:
I. Evaluate the feasibility of a smartphone application, LifeExtend-AI, in patients with early stage breast cancer currently prescribed aromatase inhibitor therapy, determined by patient usage of the application.
SECONDARY OBJECTIVES:
I. Determine a preliminary estimate of effect size of the app intervention on medication adherence, by self-report questionnaire, the Brief Medication Questionnaire (BMQ).
II. Determine a preliminary estimate of effect size of the app intervention on patient-reported AI arthralgia, as measured by the Basic Pain Inventory (BPI).
III. Determine a preliminary estimate of effect size of the app intervention on patient-reported health associated quality of life, measured by the Functional Assessment of Cancer Therapy-Endocrine symptoms (FACT-ES) questionnaire.
IV. Determine a preliminary estimate of the effect size of the app intervention on patient satisfaction with healthcare team communication, measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Treatment Satisfaction-Patient Satisfaction questionnaire (FACIT-TS-PS).
V. Determine a preliminary estimate of effect size of the app intervention on patient-reported health depression and anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS).
VI. Determine a preliminary estimate of effect size of the app intervention on patient-reported physical activity level, as measured by the International Physical Activity Questionnaire (IPAQ).
VII. Investigate psychosocial and behavioral determinants of application usage and subsequent medication adherence, including perceived AI necessity, fear of cancer recurrence, health self-efficacy, and e-health literacy.
TERTIARY/EXPLORATORY/CORRELATIVE OBJECTIVES:
I. Explore correlations between interaction with application (primary objective) and its features (including social networking), with medication adherence and patient-reported symptoms (secondary objectives).
II. Explore whether medication adherence tracked in the smartphone application correlates with adherence reported by BMQ and pharmacy fill records.
OUTLINE:
Participants receive the LifeExtend-AI smartphone application intervention for 12 weeks.
After completion of study, participants are followed up within 14 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorTarah J. Ballinger