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THRIVE Breast Cancer App Study (THRIVE)

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ClinicalTrials.gov Identifier: NCT03592771
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : September 3, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
West Cancer Center
Vector Oncology
Information provided by (Responsible Party):
Ilana Graetz, Emory University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Female Behavioral: Prompts to report adherence and symptoms via study app Behavioral: Feedback messages Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence for Women With Breast Cancer
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: Usual Care
Participants will complete a survey at baseline, and then once every 6 months until March 2022 and agree to use an electronic pill monitoring device with their AET medication.
Active Comparator: App

Participants in this group will be asked to 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 will receive reminders via text or email to use the app once per week during the 6-month intervention phase.

Participants will complete a survey at baseline, and then once every 6 months until March 2022 and agree to use an electronic pill monitoring device with their AET medication.

Behavioral: Prompts to report adherence and symptoms via study app
Text message prompts to report medication adherence and symptoms via the web-enabled study app Weekly prompts to report AET use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app. 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.

Active Comparator: App+Feedback

Participants in this group will be asked to 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 will 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 will complete a survey at baseline, and then once every 6 months until March 2022 and agree to use an electronic pill monitoring device with their AET medication.

Behavioral: Prompts to report adherence and symptoms via study app
Text message prompts to report medication adherence and symptoms via the web-enabled study app Weekly prompts to report AET use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app. 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.

Behavioral: Feedback messages
Participants will receive weekly tailored feedback messages and/or images.




Primary Outcome Measures :
  1. Adjuvant endocrine therapy (AET) medication (aromatase inhibitor or tamoxifen) adherence [ Time Frame: 12 months ]
    The investigators will capture medication adherence using an electronic monitoring pillbox (Wisepill).


Secondary Outcome Measures :
  1. Change in Functional Assessment Of Cancer Therapy-Endocrine Subscale (FACT-ES) Score [ Time Frame: Baseline, 12 months ]
    Investigators will measure relative changes in adverse symptom burden using the Functional Assessment Of Cancer Therapy-Endocrine Subscale (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. Total raw scores range from 0 to 184, with higher scores indicating greater impact from symptoms.

  2. Changes in Short Form Health Survey (SF-12) Score [ Time Frame: Baseline, 12 months ]
    Investigators will measure differences in quality of life between the three study arms 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. 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 each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.

  3. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score [ Time Frame: Baseline, 12 months ]
    Investigators will measure relative changes in adverse symptom burden 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592771


Contacts
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Contact: Ilana Graetz, PhD (901)322-9095 thrive@westclinic.com
Contact: Andrew Paladino, MS (901)212-2480 apaladin@uthsc.edu

Locations
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United States, Tennessee
West Cancer Center, MIDTOWN, 1588 Union Ave. Recruiting
Memphis, Tennessee, United States, 38104
Contact: Greg Vidal, MD    901-683-0055    gvidal@westclinic.com   
West Cancer Center, EAST MEMPHIS, 7945 Wolf River Blvd Recruiting
Memphis, Tennessee, United States, 38138
Contact: Greg Vidal, MD    901-683-0055    gvidal@westclinic.com   
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
West Cancer Center
Vector Oncology
Investigators
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Principal Investigator: Ilana Graetz, PhD Emory University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ilana Graetz, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03592771    
Other Study ID Numbers: IRB00109957
1R01CA218155 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases