- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04170920
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
Study Overview
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
- Determine a preliminary estimate of effect size of the app intervention on medication adherence, by self- report using the Brief Medication Questionnaire
- Determine a preliminary estimate of effect size of the app intervention on patient -reported AI arthralgia, as measured by the Basic Pain Inventory (BPI).
- 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.
- 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).
- 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).
- 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).
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Melvin & Bren Simon Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants who use the LifeExtend-AI application 5 or more days per week
Time Frame: 12 weeks
|
Feasibility will be measured by participants who use the application 5 or more days per week
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean medication adherence using the Brief Medication Questionnaire (BMQ)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
Self report tool for monitoring medication adherence, measuring medication knowledge, beliefs, and recall.
A score of 1 or more in each section is a positive screen for non-adherence ,belief barriers, or recall barriers.
|
Baseline and post intervention (an average of 12 weeks)
|
Mean pain score of self -reported aromatase inhibitor arthralgia using the Basic Pain Inventory (BPI)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
Mean score of the 9 item scale.
|
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)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
Likert-scaled questionnaire, with response scores ranging from 0 to 4.
|
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)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
Likert-scaled questionnaire, with response scores ranging from 0 to 3.
|
Baseline and post intervention (an average of 12 weeks)
|
Mean quality of life, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The HADS uses a scale and therefore the data returned from the HADS is ordinal.
|
Baseline and post intervention (an average of 12 weeks)
|
Mean quality of life, as measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
MET-min per week: MET level x minutes of activity x events per week.
To calculate MET minutes a week multiply the MET value given by the minutes the activity was carried out and again by the number of days that that activity was undertaken.
|
Baseline and post intervention (an average of 12 weeks)
|
Mean quality of life, as measured by the eHEALTH literacy scale (ehEALS)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
he eHEALS contains 8 items, measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree."
Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.
|
Baseline and post intervention (an average of 12 weeks)
|
Mean quality of life, as measured by the Patient Activation Measure (PAM)
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
A 13-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or herown health and healthcare on a 100 point scale.
|
Baseline and post intervention (an average of 12 weeks)
|
Mean quality of life, as measured by the assessment of cancer worry in aromatase inhibitor users
Time Frame: Baseline and post intervention (an average of 12 weeks)
|
Mean score of 3 item scale with responses on a 1-10 scale where 0 indicates "not at all" and 10 indicates "a great deal"
|
Baseline and post intervention (an average of 12 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTO-IUSCC-0715
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
Clinical Trials on LifeExtend-AI
-
Shandong UniversityCompletedArtificial Intelligence | Optical Enhancement Endoscopy | Magnifying EndoscopyChina
-
The University of Hong KongRecruitingColonic Polyp | Colonic Cancer | Colonic AdenomaHong Kong
-
Methinks Software SLNot yet recruitingBrain Ischemia | Stroke, Ischemic | Stroke, Acute | Stroke Hemorrhagic
-
Montreal Heart InstituteNot yet recruiting
-
Kıvanç AkçaHacettepe UniversityCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Sahlgrenska University Hospital, SwedenRecruiting
-
National Cancer Center, KoreaCompletedColonic DiseaseKorea, Republic of
-
Tao OUYANGActive, not recruiting
-
Istituto Clinico HumanitasCompleted