THRIVE Breast Cancer App Study

Not Applicable

Completed

• Conditions: Breast Neoplasm Female
• Interventions: Behavioral: THRIVE App; Behavioral: Tailored Feedback Messages

• Registration Number: NCT03592771
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-19
• Study Start: 2018-11-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2023-06-29
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-11
• Last Update Submitted: 2023-08-11
• Results First Posted: 2023-09-05
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 304

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
THRIVE App	THRIVE App	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.
THRIVE App+Feedback	THRIVE App	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.
THRIVE App+Feedback	Tailored Feedback Messages	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.

Primary Outcome Measures

Name	Time	Method
Adjuvant Endocrine Therapy (AET) Medication Adherence	Up to Month 12	Medication adherence with prescribed AET (aromatase inhibitor or tamoxifen) is captured using an electronic monitoring pillbox (Wisepill).

Secondary Outcome Measures

Name	Time	Method
Short Form Health Survey (SF-12) Mental Component Summary (MCS) Score	Baseline, Month 12	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.
19 Item Endocrine Symptom Subscale (ESS-19) Score of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)	Baseline, Month 12	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.
Short Form Health Survey (SF-12) Physical Component Summary (PCS) Score	Baseline, Month 12	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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms Score	Baseline, Month 12	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.

Trial Locations

Locations (2)

West Cancer Center, Midtown; 🇺🇸 Memphis, Tennessee, United States

West Cancer Center, East Memphis; 🇺🇸 Memphis, Tennessee, United States