Breast Neoplasm FemaleTHRIVENCT03592771
THRIVE Breast Cancer App Study
A study testing THRIVE App and Tailored Feedback Messages in people with Breast Neoplasm Female, run by Emory University at 2 sites in United States.
Trial summary
This study will test the use of a web-enabled app that is integrated directly with patients' electronic health records, with and without tailored feedback. The app-based intervention is designed to improve patient-provider communication outside of clinic visits, resulting in improved symptom management and adjuvant… Read more about this study
- Who is it for?
- Ages 18 to 110 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- THRIVE App and Tailored Feedback Messages
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 110 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients (age≥18)
- Diagnosis of ductal carcinoma in situ or Stage I-III hormone receptor-positive breast cancer
- New prescription for an aromatase inhibitor or tamoxifen
- Have a mobile device with a data plan or a home computer with Internet
- Have a valid email address
- Willing to complete brief surveys on a web-enabled device
- AET is indicated as standard of care
Who cannot join
- Unable to communicate in English
- Prior use of adjuvant endocrine therapy (aromatase inhibitor or tamoxifen) for current diagnosis
- Concurrently undergoing surgery, chemotherapy or radiation
- Current diagnosis of rheumatoid arthritis
- Chronic daily narcotic usage
- Patient plans to move or transfer their care within the next year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Cancer Center, Midtown
Memphis, Tennessee, 38104
West Cancer Center, East Memphis
Memphis, Tennessee, 38138
About this study
Official title: Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence
This study will test the use of a web-enabled app that is integrated directly with patients' electronic health records, with and without tailored feedback. The app-based intervention is designed to improve patient-provider communication outside of clinic visits, resulting in improved symptom management and adjuvant endocrine therapy adherence among diverse patients with hormone receptor-positive breast cancer. The researchers will evaluate the impact of the intervention on a comprehensive set of outcomes, including rigorous measures of long-term adherence, quality of life, and costs.
Read the detailed description
For women with hormone receptor-positive breast cancer, long-term use of adjuvant endocrine therapy (AET) significantly reduces the risk of hospitalizations, cancer recurrence and mortality, and increases quality of life. Despite the known benefits of AETs, many patients are nonadherent due to adverse side effects. Furthermore, lower AET adherence among black women may be contributing to the large and growing disparities in mortality outcomes. Real-time monitoring of treatment-related adverse symptoms and adherence could result in more effective management of symptoms, higher medication adherence, and ultimately lower recurrence and mortality. To date, however, only a few interventions have aimed to improve AET adherence, even fewer have targeted symptom management as a means to improve adherence, and none have found a statistically significant improvement on adherence. This study will fill this research gap by testing a web-enabled app designed with the explicit goal of improving long-term AET adherence. Patient-reported symptoms will be integrated directly with the patient's electronic health record, and concerning reports will trigger an alert to the patient's care team in order to improve timely patient-provider communication and care outside of clinic visits. In a small pilot trial of the study app, the researchers found that participants who had recently initiated a new AET and received weekly reminders to use the app reported significantly higher adherence to AETs at 8 weeks compared with a control group (91% vs. 68%, p=0.02). The proposed study builds on the success of the pilot by: 1) expanding the intervention period to six months in order to capture later-onset adverse symptoms that are slower to develop; 2) following participants for one to three years, depending on enrollment year, to test longer-term effects of the intervention on medication adherence and other outcomes; 3) including a larger sample powered to test multiple levels of the intervention; and 4) race-stratifying to test for a differential impact by race. This study will randomize 360 participants to one of three arms: 1) an "App" group (n=120) that will receive weekly reminders to use the study app; 2) an "App+Feedback" group (n=120) that will receive weekly reminders and personalized feedback based on their use of the app; or 3) a "Usual Care" group (n=120) that will receive usual care only. The app will include questions about AET adherence and adverse symptoms with built-in alerts sent to the patient's care team if any concerning symptoms or trends are reported. The researchers hypothesize that monitoring symptoms and adherence with actionable alerts and tailored feedback reports to patients will result in timelier symptom management and higher long-term adherence to AET. By evaluating the impact of the intervention on a comprehensive set of measures, including AET adherence, patient outcomes, racial disparities and resource use-related costs, this study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the patient experience.
- Conditions
- Breast Neoplasm Female
- Being tested
- THRIVE App, Tailored Feedback Messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVE AppBehavioural
Participants in the THRIVE App group receive a weekly text message to prompt them to log into the THRIVE app to answer questions about their AET adherence and related adverse symptoms. The app can be accessed through any web-enabled device or Internet browser. All participant-reported data will be automatically entered into the patient's electronic health record and easily available to the care team for review. Any concerning symptoms or changes will trigger an email alert to the patient's oncology team.
Tailored Feedback MessagesBehavioural
Participants receive weekly tailored feedback messages and/or images based on their baseline survey responses and use of the app during the 6-month intervention phase. Some tailored feedback includes links to symptom-specific educational materials and coping strategies for participants who report low-severity symptoms. Message categories are tailored to participant's responses to the app and baseline survey.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months. |
| THRIVE App | Active comparator | Participants use a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants receive reminders via text or email to use the app once per week during the 6-month intervention phase. Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months. Receives: Behavioral: THRIVE App |
| THRIVE App+Feedback | Active comparator | Participants use a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants receive reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group will also receive weekly tailored feedback text messages or images during the 6-month intervention phase. Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months. Receives: Behavioral: THRIVE App; Behavioral: Tailored Feedback Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjuvant Endocrine Therapy (AET) Medication Adherence
Medication adherence with prescribed AET (aromatase inhibitor or tamoxifen) is captured using an electronic monitoring pillbox (Wisepill).
Measured: Up to Month 12
Secondary outcomes (4)
19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Relative changes in adverse symptom burden were assessed using the Endocrine Symptom Subscale of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire. The FACT-ES is a 46-item questionnaire asking participants to report how much they have been impacted by a variety of symptoms on a 5-point scale where 0 = not at all and 4 = very much. The Endocrine Symptom Subscale consists of 19 items with total raw scores ranging from 0 to 76. Higher scores indicate greater impact from symptoms.
Measured: Baseline, Month 12
Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score
Quality of life was measured with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. A scoring algorithm is used to generate a total score for the PCS component that ranges from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Measured: Baseline, Month 12
Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score
Quality of life was measured with the SF-12 instrument. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for the MCS component that ranges from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Measured: Baseline, Month 12
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score
Relative changes in adverse symptom burden were measured using the 4-item PROMIS Self-Efficacy for Managing Symptoms short form questionnaire. Participants indicate how confident they are that they can manage their symptoms on a 5-point scale where 1 = not confident at all and 5 = very confident. Total scores range from 4 to 20 and higher scores indicate greater self-efficacy for managing symptoms.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Nov 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by Emory 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), West Cancer Center, Vector Oncology
- Responsible party
- Principal investigator, Ilana Graetz, Emory University
- Investigators
- Ilana Graetz, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592771
- Sponsor's protocol ID
- IRB00109957
- Other IDs
- 1R01CA218155
- Acronym
- THRIVE
- Status last verified
- Aug 2023
- First submitted
- 5 Jul 2018
- Last updated
- 5 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paladino AJ, Anderson JN, Krukowski RA, Waters T, Kocak M, Graff C, Blue R, Jones TN, Buzaglo J, Vidal G, Schwartzberg L, Graetz I. THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. BMC Health Serv Res. 2019 Dec 19;19(1):977. doi: 10.1186/s12913-019-4588-x.
PubMed 31856812Graetz I, Hu X, Krukowski RA, Anderson JN, Stepanski E, Vidal G, Waters TM, Schwartzberg LS. Adherence to oral endocrine therapy by menopausal status: post hoc insights from a remote monitoring randomized trial. NPJ Breast Cancer. 2026 Jan 28;12(1):33. doi: 10.1038/s41523-026-00900-9.
PubMed 41605963Hu X, Krukowski RA, Stepanski E, Anderson JN, Vidal GA, Torres MA, Schwartzberg LS, Graetz I. Racial Differences in Symptom Burden and Endocrine Therapy Adherence in Breast Cancer: A Post Hoc Analysis of a Randomized Trial. J Natl Compr Canc Netw. 2025 Sep 26;23(10):e257054. doi: 10.6004/jnccn.2025.7054.
PubMed 41005350Graetz I, Hernandez S, Hu X, Krukowski RA, Anderson JN, Waters TM, Stepanski E, Vidal GA, Schwartzberg LS. Addressing health literacy gaps in adjuvant endocrine therapy adherence: Post hoc insights from a randomized remote monitoring trial. Breast. 2025 Oct;83:104552. doi: 10.1016/j.breast.2025.104552. Epub 2025 Aug 5.
PubMed 40779883Arshad S, Hu X, Krukowski RA, Waters TM, Vidal GA, Schwartzberg L, Lipscomb J, Graetz I. COVID-19-Related Financial Hardship and Adherence to Adjuvant Endocrine Therapy Among Women With Early-Stage Breast Cancer. Health Serv Res. 2026 Apr;61(2):e14658. doi: 10.1111/1475-6773.14658. Epub 2025 Jun 17.
PubMed 40525537Krukowski RA, Hu X, Arshad S, Anderson JN, Stepanski E, Vidal GA, Schwartzberg LS, Graetz I. Symptom Monitoring App Use Associated With Medication Adherence Among Woman Survivors of Breast Cancer on Adjuvant Endocrine Therapy. JCO Clin Cancer Inform. 2024 Dec;8:e2400179. doi: 10.1200/CCI-24-00179. Epub 2024 Dec 6.
PubMed 39642329Graetz I, Hu X, Kocak M, Krukowski RA, Anderson JN, Waters TM, Curry AN, Robles A, Paladino A, Stepanski E, Vidal GA, Schwartzberg LS. Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417873. doi: 10.1001/jamanetworkopen.2024.17873.
PubMed 38935379
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence
- ClinicalTrials.gov ID
- NCT03592771
- Acronym / sponsor ID
- THRIVE / IRB00109957
- Conditions
- Breast Neoplasm Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), West Cancer Center, Vector Oncology
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Posted 5 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the use of a web-enabled app that is integrated directly with patients' electronic health records, with and without tailored feedback. The app-based intervention is designed to improve patient-provider communication outside of clinic visits, resulting in improved symptom management and adjuvant endocrine therapy adherence among diverse patients with hormone receptor-positive breast cancer. The researchers will evaluate the impact of the intervention on a comprehensive set of outcomes, including rigorous measures of long-term adherence, quality of life, and costs.
Detailed description
For women with hormone receptor-positive breast cancer, long-term use of adjuvant endocrine therapy (AET) significantly reduces the risk of hospitalizations, cancer recurrence and mortality, and increases quality of life. Despite the known benefits of AETs, many patients are nonadherent due to adverse side effects. Furthermore, lower AET adherence among black women may be contributing to the large and growing disparities in mortality outcomes. Real-time monitoring of treatment-related adverse symptoms and adherence could result in more effective management of symptoms, higher medication adherence, and ultimately lower recurrence and mortality. To date, however, only a few interventions have aimed to improve AET adherence, even fewer have targeted symptom management as a means to improve adherence, and none have found a statistically significant improvement on adherence. This study will fill this research gap by testing a web-enabled app designed with the explicit goal of improving long-term AET adherence. Patient-reported symptoms will be integrated directly with the patient's electronic health record, and concerning reports will trigger an alert to the patient's care team in order to improve timely patient-provider communication and care outside of clinic visits. In a small pilot trial of the study app, the researchers found that participants who had recently initiated a new AET and received weekly reminders to use the app reported significantly higher adherence to AETs at 8 weeks compared with a control group (91% vs. 68%, p=0.02). The proposed study builds on the success of the pilot by: 1) expanding the intervention period to six months in order to capture later-onset adverse symptoms that are slower to develop; 2) following participants for one to three years, depending on enrollment year, to test longer-term effects of the intervention on medication adherence and other outcomes; 3) including a larger sample powered to test multiple levels of the intervention; and 4) race-stratifying to test for a differential impact by race. This study will randomize 360 participants to one of three arms: 1) an "App" group (n=120) that will receive weekly reminders to use the study app; 2) an "App+Feedback" group (n=120) that will receive weekly reminders and personalized feedback based on their use of the app; or 3) a "Usual Care" group (n=120) that will receive usual care only. The app will include questions about AET adherence and adverse symptoms with built-in alerts sent to the patient's care team if any concerning symptoms or trends are reported. The researchers hypothesize that monitoring symptoms and adherence with actionable alerts and tailored feedback reports to patients will result in timelier symptom management and higher long-term adherence to AET. By evaluating the impact of the intervention on a comprehensive set of measures, including AET adherence, patient outcomes, racial disparities and resource use-related costs, this study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the "Triple Aim" - reduce costs while improving health outcomes and the patient experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months. |
| THRIVE App | Active comparator | Behavioral: THRIVE AppParticipants use a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants receive reminders via text or email to use the app once per week during the 6-month intervention phase. Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months. |
| THRIVE App+Feedback | Active comparator | Behavioral: THRIVE App, Behavioral: Tailored Feedback MessagesParticipants use a web-based app to report their AET use in the previous 7 days and any treatment-related symptoms or changes in the severity of symptoms. Participants receive reminders via text or email to use the app once per week during the 6-month intervention phase. In addition, participants in this group will also receive weekly tailored feedback text messages or images during the 6-month intervention phase. Participants use an electronic pill monitoring device with their AET medication and complete a survey at baseline and again after 12 months. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult female patients (age≥18)
- Diagnosis of ductal carcinoma in situ or Stage I-III hormone receptor-positive breast cancer
- New prescription for an aromatase inhibitor or tamoxifen
- Have a mobile device with a data plan or a home computer with Internet
- Have a valid email address
Key exclusion criteria (6 listed)
- Unable to communicate in English
- Prior use of adjuvant endocrine therapy (aromatase inhibitor or tamoxifen) for current diagnosis
- Concurrently undergoing surgery, chemotherapy or radiation
- Current diagnosis of rheumatoid arthritis
- Chronic daily narcotic usage
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 |
|---|---|---|
| THRIVE AppParticipants in the THRIVE App group receive a weekly text message to prompt them to log into the THRIVE app to answer questions about their AET adherence and related adverse symptoms. The app can be accessed through any web-enabled device or Internet browser. All participant-reported data will be automatically entered into the patient's electronic health record and easily available to the care team for review. Any concerning symptoms or changes will trigger an email alert to the patient's oncology team. | Behavioural | THRIVE App, THRIVE App+Feedback |
| Tailored Feedback MessagesParticipants receive weekly tailored feedback messages and/or images based on their baseline survey responses and use of the app during the 6-month intervention phase. Some tailored feedback includes links to symptom-specific educational materials and coping strategies for participants who report low-severity symptoms. Message categories are tailored to participant's responses to the app and baseline survey. | Behavioural | THRIVE App+Feedback |
Primary outcome
Adjuvant Endocrine Therapy (AET) Medication Adherence
Time frame: Up to Month 12
Medication adherence with prescribed AET (aromatase inhibitor or tamoxifen) is captured using an electronic monitoring pillbox (Wisepill).
4 secondary outcomes
19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Time frame: Baseline, Month 12
Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score
Time frame: Baseline, Month 12
Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score
Time frame: Baseline, Month 12
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31856812Paladino AJ, Anderson JN, Krukowski RA, Waters T, Kocak M, Graff C, Blue R, Jones TN, Buzaglo J, Vidal G, Schwartzberg L, Graetz I. THRIVE study protocol: a randomized controlled trial evaluating a web-based app and tailored messages to improve adherence to adjuvant endocrine therapy among women with breast cancer. BMC Health Serv Res. 2019 Dec 19;19(1):977. doi: 10.1186/s12913-019-4588-x.
- Derived from this study: PubMed 41605963Graetz I, Hu X, Krukowski RA, Anderson JN, Stepanski E, Vidal G, Waters TM, Schwartzberg LS. Adherence to oral endocrine therapy by menopausal status: post hoc insights from a remote monitoring randomized trial. NPJ Breast Cancer. 2026 Jan 28;12(1):33. doi: 10.1038/s41523-026-00900-9.
- Derived from this study: PubMed 41005350Hu X, Krukowski RA, Stepanski E, Anderson JN, Vidal GA, Torres MA, Schwartzberg LS, Graetz I. Racial Differences in Symptom Burden and Endocrine Therapy Adherence in Breast Cancer: A Post Hoc Analysis of a Randomized Trial. J Natl Compr Canc Netw. 2025 Sep 26;23(10):e257054. doi: 10.6004/jnccn.2025.7054.
- Derived from this study: PubMed 40779883Graetz I, Hernandez S, Hu X, Krukowski RA, Anderson JN, Waters TM, Stepanski E, Vidal GA, Schwartzberg LS. Addressing health literacy gaps in adjuvant endocrine therapy adherence: Post hoc insights from a randomized remote monitoring trial. Breast. 2025 Oct;83:104552. doi: 10.1016/j.breast.2025.104552. Epub 2025 Aug 5.
- Derived from this study: PubMed 40525537Arshad S, Hu X, Krukowski RA, Waters TM, Vidal GA, Schwartzberg L, Lipscomb J, Graetz I. COVID-19-Related Financial Hardship and Adherence to Adjuvant Endocrine Therapy Among Women With Early-Stage Breast Cancer. Health Serv Res. 2026 Apr;61(2):e14658. doi: 10.1111/1475-6773.14658. Epub 2025 Jun 17.
- Derived from this study: PubMed 39642329Krukowski RA, Hu X, Arshad S, Anderson JN, Stepanski E, Vidal GA, Schwartzberg LS, Graetz I. Symptom Monitoring App Use Associated With Medication Adherence Among Woman Survivors of Breast Cancer on Adjuvant Endocrine Therapy. JCO Clin Cancer Inform. 2024 Dec;8:e2400179. doi: 10.1200/CCI-24-00179. Epub 2024 Dec 6.
- Derived from this study: PubMed 38935379Graetz I, Hu X, Kocak M, Krukowski RA, Anderson JN, Waters TM, Curry AN, Robles A, Paladino A, Stepanski E, Vidal GA, Schwartzberg LS. Remote Monitoring App for Endocrine Therapy Adherence Among Patients With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417873. doi: 10.1001/jamanetworkopen.2024.17873.
- Individual participant dataSharing planned: No
Related trials for Breast Neoplasm Female
RecruitingObservational study
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Cancer, Cancer Diagnosis
Active, not recruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Breast Cancer
Recruiting
A Study of a Side Effects and Resource Navigation Program for People With Cancer
Kidney Cancer, Bladder Cancer
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Ilana Graetz, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE App and Tailored Feedback Messages in people with Breast Neoplasm Female, run by Emory University at 2 sites 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 7 inclusion and 6 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 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 5 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adjuvant Endocrine Therapy (AET) Medication Adherence (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03592771, which also lists 7 linked publications.
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 5 Sep 2023.