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

NCT04170920 | Completed DMC

• 1 other identifier: CTO-IUSCC-0715
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; DCIS

Keywords

breast cancer; DCIS; aromatase inhibitor

Outcome Measures

Primary Outcomes (1)

• Participants who use the LifeExtend-AI application 5 or more days per week

  Feasibility will be measured by participants who use the application 5 or more days per week

  12 weeks

Secondary Outcomes (9)

• Mean medication adherence using the Brief Medication Questionnaire (BMQ)

  Baseline and post intervention (an average of 12 weeks)

• Mean pain score of self -reported aromatase inhibitor arthralgia using the Basic Pain Inventory (BPI)

  Baseline and post intervention (an average of 12 weeks)

• Mean quality of life score, measured by the Functional Assessment of Cancer Therapy- Endocrine symptoms (FACT-ES)

  Baseline and post intervention (an average of 12 weeks)

• Mean satisfaction with healthcare team communication, measured by the FACIT- Treatment Satisfaction-Patient Satisfaction questionnaire (FACIT-TS-PS)

  Baseline and post intervention (an average of 12 weeks)

• Mean quality of life, as measured by the Hospital Anxiety and Depression Scale (HADS)

  Baseline and post intervention (an average of 12 weeks)

Study Arms (1)

Mobile Health Application Intervention

EXPERIMENTAL

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.

Device: LifeExtend-AI

Interventions

LifeExtend-AI 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.

Mobile Health Application Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old at the time of informed consent
• Regular access to a smartphone capable of downloading the application
• iOS 11 or later (iPhone5, iPhone SE or newer)
• Android 6 or later (Android 9 is current version)
• History of DCIS, stage I, II, or III invasive breast cancer
• 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.
• Ovarian suppression with AI is allowed in premenopausal patients.
• Prior SERM and now switching to an AI for the first time is allowed.
• Concurrent trastuzumab, pertuzumab, or TDM1 is allowed.
• Concurrent neratinib or other oral cancer directed medication is not allowed.
• ECOG performance status of 0-2

You may not qualify if:

• Metastatic breast cancer or other active malignancy
• Locally recurrent breast cancer is allowed if treated with surgical excision and AI is prescribed with curative intent.
• History of prior treated malignancies, other than breast cancer, that are now stable, are in remission, and do not require active therapy, are acceptable
• Unable to read the English language or otherwise participate in the study procedures in the opinion of the treating investigator.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Tarah Ballinger, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 20, 2019
• Study Start: February 17, 2020
• Primary Completion: April 29, 2022
• Study Completion: August 9, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

US (1)