Pilot Study of a an App to Improve Medication Adherence in Breast Cancer Survivors Receiving AIs

NCT ID: NCT04170920

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2022-08-09

Brief Summary

The purpose of this study is to evaluate the feasibility of an mobile-health strategy to improve patient-reported symptoms, promote life-saving medication adherence, and encourage healthy lifestyle behaviors in early stage breast cancer survivors receiving adjuvant Aromatase inhibitors, while beginning to predict psycho-social and demographic characteristics of those who benefit most from this approach. This will provide preliminary experience and evidence for larger, randomized clinical trials evaluating this methodology, which will have immediate and scalable influence on cancer survivor ship.

Detailed Description

This is a single arm, prospective, observational study enrolling up to 50 patients to the intervention in groups of 10 within Indiana University Simon Cancer Center. Subjects must meet eligibility at the time of informed consent. Once 10 eligible subjects are identified and have signed informed consent, each subject will return for their baseline visit and begin the app intervention with their group of 10.

Primary Objective 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

1. Determine a preliminary estimate of effect size of the app intervention on medication adherence, by self- report using the Brief Medication Questionnaire

2. Determine a preliminary estimate of effect size of the app intervention on patient -reported AI arthralgia, as measured by the Basic Pain Inventory (BPI).

3. 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.

4. Determine a preliminary estimate of the effect size of the app intervention on patient satisfaction with healthcare team communication, measured by the FACIT- Treatment Satisfaction-Patient Satisfaction questionnaire (FACIT-TS-PS).

5. 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).

6. 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).

7. 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.

Conditions

Breast Cancer; DCIS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mobile Health Application Intervention

LifeExtend-AI (LX-AI) will be piloted by adding Aromatase Inhibitor (AI)- specific features to LifeExtend, an already existing healthy lifestyle behavior application produced by LifeOmic. This application includes features for tracking activity, diet, sleep, and body weight, as well as creating "to-do" lists and participating in closed social networking for support and encouragement. LifeExtend-AI will add features to track AI adherence and patient-reported joint pain, with alerts sent to both the participant and the healthcare team in response to these parameters. In addition, the app contains educational videos and articles, to which articles addressing management of AI- related toxicities (including exercise) will be added.

Group Type: EXPERIMENTAL

LifeExtend-AI

Intervention Type: DEVICE

LifeExtend-AI (LX-AI) will be piloted by adding AI- specific features to LifeExtend, an already existing healthy lifestyle behavior application produced by LifeOmic. This application includes features for tracking activity, diet, sleep, and body weight, as well as creating "to-do" lists and participating in closed social networking for support and encouragement. LifeExtend-AI will add features to track AI adherence and patient-reported joint pain, with alerts sent to both the participant and the healthcare team in response to these parameters. In addition, the app contains educational videos and articles, to which articles addressing management of AI- related toxicities (including exercise) will be added.

Interventions

LifeExtend-AI

LifeExtend-AI (LX-AI) will be piloted by adding AI- specific features to LifeExtend, an already existing healthy lifestyle behavior application produced by LifeOmic. This application includes features for tracking activity, diet, sleep, and body weight, as well as creating "to-do" lists and participating in closed social networking for support and encouragement. LifeExtend-AI will add features to track AI adherence and patient-reported joint pain, with alerts sent to both the participant and the healthcare team in response to these parameters. In addition, the app contains educational videos and articles, to which articles addressing management of AI- related toxicities (including exercise) will be added.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years old at the time of informed consent

2. Regular access to a smartphone capable of downloading the application

1. iOS 11 or later (iPhone5, iPhone SE or newer)

2. Android 6 or later (Android 9 is current version)

3. History of DCIS, stage I, II, or III invasive breast cancer

4. Currently prescribed an aromatase inhibitor (letrozole, anastrozole, exemestane) or planned to be initiated on one by the time of signing informed consent. Patient already on an AI must have been prescribed this medication for a total of 36 months or less.

1. Ovarian suppression with AI is allowed in premenopausal patients.

2. Prior SERM and now switching to an AI for the first time is allowed.

3. Concurrent trastuzumab, pertuzumab, or TDM1 is allowed.

4. Concurrent neratinib or other oral cancer directed medication is not allowed.

5. ECOG performance status of 0-2

Exclusion Criteria

1. Metastatic breast cancer or other active malignancy

1. Locally recurrent breast cancer is allowed if treated with surgical excision and AI is prescribed with curative intent.

2. History of prior treated malignancies, other than breast cancer, that are now stable, are in remission, and do not require active therapy, are acceptable

2. Unable to read the English language or otherwise participate in the study procedures in the opinion of the treating investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tarah J Ballinger, MD

Assistant Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarah Ballinger, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

CTO-IUSCC-0715

Identifier Type: -

Identifier Source: org_study_id