Breast CancerNCT04170920
Pilot Study of a an App to Improve Medication Adherence in Breast Cancer Survivors Receiving AIs
A study testing LifeExtend-AI in people with Breast Cancer and DCIS, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, DCIS
- What is being tested?
- LifeExtend-AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Pilot Study of a Mobile Health Strategy to Improve Medication Adherence in Breast Cancer Survivors Receiving Aromatase Inhibitors
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.
Read the 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.
- Conditions
- Breast Cancer, DCIS
- Being tested
- LifeExtend-AI
- Keywords
- breast cancer, DCIS, aromatase inhibitor
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeExtend-AIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LifeExtend-AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (9)
Mean medication adherence using the Brief Medication Questionnaire (BMQ)
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.
Measured: Baseline and post intervention (an average of 12 weeks)
Mean pain score of self -reported aromatase inhibitor arthralgia using the Basic Pain Inventory (BPI)
Mean score of the 9 item scale.
Measured: 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)
Likert-scaled questionnaire, with response scores ranging from 0 to 4.
Measured: 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)
Likert-scaled questionnaire, with response scores ranging from 0 to 3.
Measured: Baseline and post intervention (an average of 12 weeks)
Mean quality of life, as measured by the Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline and post intervention (an average of 12 weeks)
Mean quality of life, as measured by the International Physical Activity Questionnaire (IPAQ)
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.
Measured: Baseline and post intervention (an average of 12 weeks)
Mean quality of life, as measured by the eHEALTH literacy scale (ehEALS)
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.
Measured: Baseline and post intervention (an average of 12 weeks)
Mean quality of life, as measured by the Patient Activation Measure (PAM)
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.
Measured: 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
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"
Measured: Baseline and post intervention (an average of 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start17 Feb 2020
- Primary completion29 Apr 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarah J Ballinger, MD, Indiana University
- Investigators
- Tarah Ballinger, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170920
- Sponsor's protocol ID
- CTO-IUSCC-0715
- Status last verified
- Sep 2022
- First submitted
- 13 Nov 2019
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Mobile Health Strategy to Improve Medication Adherence in Breast Cancer Survivors Receiving Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT04170920
- Acronym / sponsor ID
- CTO-IUSCC-0715
- Conditions
- Breast Cancer, DCIS
- Keywords
- breast cancer, DCIS, aromatase inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Application Intervention | Experimental | Device: LifeExtend-AILifeExtend-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 18 years old at the time of informed consent
- Regular access to a smartphone capable of downloading the application
- 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.
- ECOG performance status of 0-2
Key exclusion criteria (4 listed)
- Metastatic breast cancer or other active malignancy
- Unable to read the English language or otherwise participate in the study procedures in the opinion of the treating investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeExtend-AILifeExtend-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. | Device | Mobile Health Application Intervention |
Primary outcome
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
9 secondary outcomes
Mean medication adherence using the Brief Medication Questionnaire (BMQ)
Time frame: 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 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)
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)
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)
Mean quality of life, as measured by the International Physical Activity Questionnaire (IPAQ)
Time frame: 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)
Mean quality of life, as measured by the Patient Activation Measure (PAM)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarah Ballinger, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeExtend-AI in people with Breast Cancer and DCIS, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants who use the LifeExtend-AI application 5 or more days per week (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.