Clinical trial · Interventional
Pilot Study of a an App to Improve Medication Adherence in Breast Cancer Survivors Receiving AIs
Pilot Study of a Mobile Health Strategy to Improve Medication Adherence in Breast Cancer Survivors Receiving Aromatase Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LifeExtend-AI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mobile Health Application Intervention
- description
- 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.
- interventionNames
- Device: LifeExtend-AI
Primary outcomes (1)
- measure
- Participants who use the LifeExtend-AI application 5 or more days per week
- timeFrame
- 12 weeks
- description
- Feasibility will be measured by participants who use the application 5 or more days per week
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available