A RANDOMIZED CONTROLLED TRIAL Science Center 1 ACKNOWLEDGEMENTS - - PowerPoint PPT Presentation
USE OF A WEB-ENABLED APP FOR BREAST CANCER ILANA GRAETZ, PhD Department of Preventive Medicine SYMPTOM MANAGEMENT AND MEDICATION ADHERENCE: University of Tennessee Health A RANDOMIZED CONTROLLED TRIAL Science Center 1 ACKNOWLEDGEMENTS
ILANA GRAETZ, PhD Department of Preventive Medicine University of Tennessee Health Science Center
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UTHSC: Caitlin N. McKillop, PhD Vector Oncology: Edward Stepanski, PhD West Cancer Center: Gregory A. Vidal, MD, PhD and Lee S. Schwartzberg, MD
Funded by the UTHSC Clinical and Translational Science Institute
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1 in 8 women diagnosed with breast cancer Most with hormone receptor-positive tumors Long-term use of adjuvant endocrine therapy (AET): Lowers risk of recurrence Increases survival Lowers risk of hospitalizations
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Symptoms usually occur early Low adherence to adjuvant endocrine therapy 1 in 3 stop taking within 5 years Black women have lower AET use and adherence Real time monitoring of adverse symptoms could improve adherence and provide better health
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Patients used the app weekly to report symptoms and AI adherence for 8 weeks Alerts: Adverse symptoms and AI nonadherence triggered email alerts to patient’s care team Eligibility: Adult women with diagnosis of early stage (I-III) hormone receptor-positive breast cancer receiving their first prescription for an AI in the West Cancer Center in Memphis, TN
Randomized into two groups:
Outcomes
Scale (MMAS-4)
Cancer Therapy Endocrine Symptoms (FACT-ES) Outcomes based on self-administered surveys collected from all participants at baseline and follow-up
Assessed for eligibility (n=56) Excluded (n=9)
Analyzed (n=21) Discontinued intervention (n=1) Allocated to App+Reminder & received intervention (n=22) Lost to follow-up (n=1) Discontinued intervention (n=2) Allocated to App & received intervention (n=25) Analyzed (n=22) Allocation Analysis (N=43) Follow-Up Randomized (n=47) Enrollment
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Total App+Reminder App
N (%) 44 (100.0) 21 (47.7) 23 (52.3) Age: 18-49 11.4 9.5 13.0 50-65 56.8 52.4 60.9 Over 65 31.8 38.1 26.1 Race/Ethnicity: White 75.0 81.0 69.6 Black 22.7 14.3 30.4 Hispanic 2.3 4.8 0.0 Lower Health Literacy 27.5 36.8 19.1 No Degree/HS/Some College 60.0 57.9 61.9 Income: ≤150% FPL 36.4 23.5 50.0 >150% to <400% FPL 27.3 35.3 18.8 ≥400% FPL 36.3 41.2 31.3 Married/Long-Term Relationship 73.8 70.0 77.3 Stage I at diagnosis 54.5 61.9 47.8
FPL=Federal Poverty Level. No significant differences between App and Usual Care groups (t-tests for group comparison)
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38% 27% 42% 73%* 90%* 71%*
Overall
App+Reminder
App
App Percent Use (Logins/Weeks Enrolled)
Low app use without reminders With reminders, App use high for both White and Black participants
p<0.05 comparing App vs Usual Care groups
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38% 27% 42% 73%* 90%* 71%*
Overall
App+Reminder
App
App Percent Use (Logins/Weeks Enrolled)
Low app use without reminders With reminders, App use high for both White and Black participants
p<0.05 comparing App vs Usual Care groups
p<0.05 comparing App vs Usual Care groups
73% 57% 80% 100%* 100%* 100%*
App App+Reminder % with High Reported AET Adherence
p<0.05 comparing App vs Usual Care groups
73% 57% 80% 100%* 100%* 100%*
App App+Reminder % with High Reported AET Adherence
45.3 49.2 54.4 65.9
30 35 40 45 50 55 60 65 70
Baseline Follow-up
App+Reminder App
DID = 7.6 (p=0.191)
“It was beneficial - I actually used it for a symptom… I was having and the nurse called me back right away … I wasn’t expecting that, so that was nice to have someone call to check on you, so I feel like it was beneficial for that reason and because I could do it in my own privacy, like, at home, you know, that was nice.” “I can go in and note my symptoms before I went to see the doctor and, so I wasn’t sitting in there [in the clinic] and trying to fill it out really quickly on their
and fill out my symptoms right away, so I wouldn’t forget. Having to wait for three weeks or whatever to fill out my symptoms makes it hard to remember.”
“It was beneficial - I actually used it for a symptom… I was having and the nurse called me back, right away … I wasn’t expecting that, so that was nice to have someone call to check on you, so I feel like it was beneficial for that reason and because I could do it in my own privacy, like, at home, you know, that was nice.” “I can go in and note my symptoms before I went to see the doctor and, so I wasn’t sitting in there [in the clinic] and trying to fill it out really quickly on their iPad... Having to wait for three weeks or whatever to fill out my symptoms makes it hard to remember.”
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App use low without reminders
App with weekly reminders improved short-term AI adherence
Trends in symptom burden suggestive of better symptom management among App+Reminder group
If short-term gains in adherence persist, this low-cost intervention could improve survival outcomes
Future studies should include a longer follow-up period and capture potential impact on patient outcomes and disparities in outcomes
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Contact Information ILANA GRAETZ, PhD Department of Preventive Medicine University of Tennessee Health Science Center 66 N Pauline, Suite 608 Memphis, TN 38162 Phone: (901) 448-2285 Email: igraetz@uthsc.edu
18% 14% 10% 0% Sometimes if you feel worse when you take your medicine, do you stop taking it? Do you ever forget to take your medicine? Do you ever have problems remembering to take your medication? When you feel better, do you sometimes stop taking your medicine?
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App
All participants in App+Reminder group reported high adherence
From the Noun Project
Taking medicine by Gan Khoon Lay Headache by Gan Khoon Lay Headache by Lisole Bump by Gan Khoon Lay Hospital by Royyan Wijaya Doctor by Artem Kovyazin Text by romzicon Warning by Rockicon
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Patient: Symptom Experience Perception of symptoms Response to symptoms:
Care Team: Management Strategies Evaluation of symptoms
Outcomes
Adapted from Dodd and colleagues (2008)
Adapted from the Symptom Management Model
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1. I have hot flashes 2. I have cold sweats 3. I have night sweats 4. I have vaginal discharge 5. I have vaginal itching/irritation 6. I have vaginal bleeding or spotting 7. I have vaginal dryness 8. I have pain or discomfort with intercourse 9. I have lost interest in sex
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Response options: 0 (not at all) to 4 (very much)
Below is a list of statements that other people with your illness have said are important. Please indicate your response as it applies to the past 7 days.
Total App+ Reminder App Patients N (%) 44 (100.0) 21 (47.7) 23 (52.3) Age: 18-49 11.4 9.5 13.0 50-65 56.8 52.4 60.9 Over 65 31.8 38.1 26.1 Race/Ethnicity: White 75.0 81.0 69.6 Black 22.7 14.3 30.4 Hispanic 2.3 4.8 0.0 Low Health Literacy 27.5 36.8 19.1 No Degree/HS/Some College 60.0 57.9 61.9 Income: ≤150% FPL 36.4 23.5 50.0 >150% to <400% FPL 27.3 35.3 18.8 ≥400% FPL 36.3 41.2 31.3 Married/Long-Term Relationship 73.8 70 77.3 Stage I at diagnosis 54.5 61.9 47.8 Perceived Poor/Fair Health 29.3 31.6 27.3 AI type: Anastrozole 65.9 61.9 69.6 Arimidex 25.0 23.8 26.1 Exemestane 9.1 14.3 4.3