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 Co-authors 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 2
BREAST CANCER AND ADJUVANT ENDOCRINE THERAPY 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 3
ADVERSE SYMPTOMS DRIVE AET NONADHERENCE 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 outcomes 4
OBJECTIVE To evaluate a pilot randomized controlled trial of a web- enabled application (app) to provide real-time symptom and adherence monitoring with built-in alerts between visits among women new aromatase inhibitor (AI) prescription
APP INTERVENTION 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
RANDOMIZATION AND OUTCOMES Randomized into two groups: • App+Reminder : Weekly reminders to use the app • App : Asked to use the app, but no reminders Outcomes 1. App Use: Number of logins/weeks enrolled 2. AI adherence : 4-item Morisky Medication Adherence Scale (MMAS-4) 3. Changes in symptom burden : Functional Assessment of 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) Enrollment - Inclusion criteria not met (n=3) - Declined to participate (n=6) Randomized (n=47) Allocation Allocated to App & Allocated to App+Reminder & received intervention (n=25) received intervention (n=22) Lost to follow-up (n=1) Discontinued intervention (n=1) Follow-Up Discontinued intervention (n=2 ) Analysis (N=43) Analyzed (n=22) Analyzed (n=21)
PARTICIPANT CHARACTERISTICS Total App+Reminder App 44 (100.0) 21 (47.7) 23 (52.3) N (%) 11.4 9.5 13.0 Age: 18-49 56.8 52.4 60.9 50-65 31.8 38.1 26.1 Over 65 75.0 81.0 69.6 Race/Ethnicity: White Black 22.7 14.3 30.4 Hispanic 2.3 4.8 0.0 Lower Health Literacy 27.5 36.8 19.1 60.0 57.9 61.9 No Degree/HS/Some College 36.4 23.5 50.0 Income: ≤150% FPL 27.3 35.3 18.8 >150% to <400% FPL 36.3 41.2 31.3 ≥400% FPL 73.8 70.0 77.3 Married/Long-Term Relationship 54.5 61.9 47.8 Stage I at diagnosis FPL=Federal Poverty Level. No significant differences between App and Usual Care groups (t-tests for group comparison) 9
APP USE Overall App App 38% Overall Low app use App+Reminder 73%* without reminders 27% With reminders, Black 90%* App use high for both White and Black participants 42% White 71%* Percent Use (Logins/Weeks Enrolled) 10 p<0.05 comparing App vs Usual Care groups
APP USE Overall App App 38% Overall Low app use App+Reminder 73%* without reminders 27% With reminders, Black 90%* App use high for both White and Black participants 42% White 71%* Percent Use (Logins/Weeks Enrolled) 11 p<0.05 comparing App vs Usual Care groups
AROMATASE INHIBITOR ADHERENCE Adherence higher App 73% among Overall App+Reminder 100%* App+Reminder group 57% Black 100%* Lower adherence among Black participants in the 80% White App group 100%* % with High Reported AET Adherence p<0.05 comparing App vs Usual Care groups
AROMATASE INHIBITOR ADHERENCE Adherence higher App 73% among Overall App+Reminder 100%* App+Reminder group 57% Black 100%* Lower adherence among Black participants in the 80% White App group 100%* % with High Reported AET Adherence p<0.05 comparing App vs Usual Care groups
RESULTS: SYMPTOM BURDEN 70 65.9 • 65 Trend suggests smaller 60 symptom burden increase 54.4 55 DID = 7.6 among App+Reminder (p=0.191) 50 49.2 group 45.3 45 40 App+Reminder 35 App 30 Baseline Follow-up
SEMI-STRUCTURED INTERVIEWS “ It was beneficial - I actually used it for a “ I can go in and note my symptoms symptom… I was having and the nurse before I went to see the doctor and, so I called me back right away … I wasn’t wasn’t sitting in there [in the clinic] and expecting that, so that was nice to have trying to fill it out really quickly on their someone call to check on you, so I feel iPad. I felt like if I could go to the apps like it was beneficial for that reason and and fill out my symptoms right away, so I because I could do it in my own privacy, wouldn’t forget. Having to wait for three like, at home, you know, that was nice .” weeks or whatever to fill out my symptoms makes it hard to remember .”
SEMI-STRUCTURED INTERVIEWS “ It was beneficial - I actually used it for a “ I can go in and note my symptoms symptom… I was having and the nurse before I went to see the doctor and, so I called me back, right away … I wasn’t wasn’t sitting in there [in the clinic] and expecting that, so that was nice to have trying to fill it out really quickly on their someone call to check on you, so I feel iPad... Having to wait for three weeks or like it was beneficial for that reason and whatever to fill out my symptoms makes because I could do it in my own privacy, it hard to remember .” like, at home, you know, that was nice .”
LIMITATIONS Small sample and short follow-up Self-reported measure of adherence Single clinic, limited generalizability English-only 17
CONCLUSIONS App use low without reminders • With reminders, app use high overall and among Black and White patients App with weekly reminders improved short-term AI adherence • Adherence high among both Black and White patients Trends in symptom burden suggestive of better symptom management among App+Reminder group
IMPLICATIONS If short-term gains in adherence persist, this low-cost intervention could improve survival outcomes May help curb growing breast cancer mortality disparity Future studies should include a longer follow-up period and capture potential impact on patient outcomes and disparities in outcomes
Thank you! Any questions? 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 20
ADHERENCE: MMAS-4 AMONG (APP GROUP ONLY) Sometimes if you feel worse when you 18% App take your medicine, do you stop taking it? Do you ever forget to take your medicine? 14% Do you ever have problems remembering 10% to take your medication? When you feel better, do you sometimes All participants in App+Reminder 0% stop taking your medicine? group reported high adherence 21
IMAGE CREDITS 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 22
CONCEPTUAL FRAMEWORK Adapted from the Symptom Management Model Care Team: Management Strategies Evaluation of symptoms • Built-in alerts • EHR-integration • Clinical management - Call, change/add Rx Outcomes Patient: Symptom Experience Perception of symptoms • Short term: Symptom Burden • Long term: Response to symptoms: Survival o Disparities • o AI Adherence o Cancer recurrence • App real-time reporting Adapted from Dodd and colleagues (2008)
MMAS-4 QUESTIONS 1. Do you ever forget to take your medicine? 2. Do you ever have problems remembering to take your medication? 3. When you feel better, do you sometimes stop taking your medicine? 4. Sometimes if you feel worse when you take your medicine, do you stop taking it? 24
Below is a list of statements that other people with your FACT-ES QUESTIONS illness have said are important. Please indicate your response as it applies to the past 7 days. 11. I feel lightheaded (dizzy) 1. I have hot flashes 12. I have been vomiting 2. I have cold sweats 13. I have diarrhea (diarrhoea) 3. I have night sweats 14. I get headaches 4. I have vaginal discharge 15. I feel bloated 5. I have vaginal itching/irritation 16. I have breast sensitivity/tenderness 6. I have vaginal bleeding or spotting 17. I have mood swings 7. I have vaginal dryness 18. I am irritable 8. I have pain or discomfort with intercourse 19. I have pain in my joints 9. I have lost interest in sex Response options: 0 (not at all) to 4 (very much) 10. I have gained weight 25
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