1. Acceptability and Preliminary Efficacy of a SMS Text Message Intervention in Older Cancer Patients Sandra L. Spoelstra, PhD, RN GSA Annual Meeting Washington, D.C. November 8th, 2014

2. Multi-disciplinary Team Barbara Given, PhD, RN, FAAN University Distinguished Professor, College of Nursing Alla Sikorskii, PhD Associate Professor, Department of Statistics and of Probability Constantinos K. Coursaris, PhD Professor, Department of Telecommunication, Information Studies Atreyee Majumder, MS Doctoral Candidate, Department Statistics and of Probability Tracy DeKoekkoek, BSN, RN Doctoral Student, College of Nursing Monica Schueller, BA Project Manager, College of Nursing Charles W. Given, PhD Professor, Department of Family Medicine, Institute of Health Policy

3. Funding Supported by a grant entitled: Text Messaging to Improve Symptom Management & Adherence to Oral Chemotherapy Agents o McKesson Foundation Inc., Mobilizing for Health Grant Program, in San Francisco, California. January 2013 to June 2014

4. Objective for Presentation Report on: 1)Proof-of-concept of a 10-week SMS mHealth intervention using text messages (TMs) in cancer patients prescribed oral agents. 2)Preliminary efficacy of TM intervention with respect to symptom severity & oral agent adherence.

5. Background & Significance Cancer treatment is shifting paradigms. >50 targeted oral anti-cancer agents. ~25% of cancer treatment in pill form. Therapeutic outcome of treatment depends on adherence. Research indicates adherence is a significant problem: –42% miss doses –10% not refilling scripts Symptoms often become so severe that it interferes with taking oral agent medication.

6. Emerging: Mobile health (mHealth) technology: –Mobile phones are the most commonly used form of technology worldwide. –SMS text messaging (TMs) is becoming popular. Evidence is emerging on the automatic response of TMs to motivate behavior change to take action. –Cues behavior. –Integrates symptom management and adherence to oral agent in daily life.

7. Guiding Framework Self-Efficacy Theory (Bandura) –Belief in capabilities to perform behavior influenced by motivation & affective states. –Research shows 21-days are needed to form a pattern for behavior. –Cues as prompts have proven effectiveness. –Engaging patients via TMs would heighten self-efficacy, promoting adherence & symptom management.

8. Sample & Setting N=80 (40=TM Group; 40=Control Group) –Inclusion criteria: >21, prescribed an oral agent, owned a cell phone, able to receive and send TMs, in English language –Exclusion criteria: No phone, unable to TM, or cognitively impaired –Recruitment: 2-community cancer centers in the Midwest Large Specialty Pharmacy July 2013—January 2014 (7 months)

9. Methods Randomized controlled trial Recruited & consented Data collection: –Week 1 Baseline interview Random assignment & patients informed –Week 2-9 AVR assessed adherence & symptoms –Week 10 Exit interview & satisfaction survey

10. Intervention Automated platform: –Timed to medication regimen (just-in-time), 2-way messages TMs: 160 characters; theory driven using motivation & self-efficacy scripts –Test TM –Adherence TMs (6) rotated for 21—28 days –Symptom management TMs sent weekly –TM to request additional week & confirmation TM –End of the study TM

11. Measures Characteristics Acceptability (offered enrollment vs. accepted), feasibility (# TM delivered), and satisfaction (tool previously developed) Self-efficacy: MASES-R, MARS, BMQ Medication Specific Social Support (MSSS) PROMIS: Physical function & depression Cimprich: Attention Function Inventory Symptoms: Given Inventory presence & severity (19) Adherence: self-report, pharmacy dispensing records & relative dose intensity

12. Results Of 80 who completed baseline interview –12 patients withdrew, were lost to follow-up, or were deceased No differences at baseline, except >breast cancer TM group (n=14, 35% compared to n=5, 12.5%; p=.04)

13. Characteristics Mean age 58.5 (SD 10.7; range 26—92) 60% (n=48) female Race: –83.3% (n=67) Caucasian –11% (n=9) African American –7.5% (n=6) Hispanic 73% (n=58) some college education 23.8% (n=19) employed

14. Conditions Comorbidity mean 1.51 (SD 1.38) Cancer site: –Breast (23.8%, n=19) –Prostate (11.5%, n=9) –Lung (10%, n=8) –Colon (8.8%, n=5) –Multiple myeloma (7.5%, n=6) Stage III-IV: 50% (n=40)

15. Oral Agent Regimen 21 different oral agent medications 58.8% (n=47) Simple Dosing –Once daily 41.3% (n=33) Complex Dosing –Multiple drugs –More than once daily –Cycling on & off

16. Health Status Symptoms –Mean number 5.8 (SD 3.56; range 0—19) –Mean summed severity 30.99 (SD 23.74; 0—190) Depression –Mean 46.93 (SD 8.41), below mean of US population Physical function mean –Mean 44.51 (SD 8.17), below mean of US population Social Support mean 4.18 (SD 3.4)

17. Acceptability -98% (39 of 40) completed the entire intervention -83% (810 of 1111) responded to TMs with a return text message -81% (n=30 of 37) reported reading TMs all the time

18. Type of TM Sent to PatientNumber TM Sent Welcome to the study 53 Medication reminders 1,111 Timed to medication810 Repeated, wrong response after TM sent301 Symptom management prompts 116 Continuation another week request 52 Confirmed additional week if desired 10 End of the study 17 TOTAL NUMBER OF TM SENT 1,359

19. Physical Function, Self-efficacy, Depression, & Cognition Physical function better TM group (47.6 [SE1.2]; 44.9 [SE 1.1]), moderate effect size 0.40 Self-efficacy small effect size TM BMQ (26.3 [SE 0.9] to 26.6 [SE 0.7]; effect size -0.07) MASES-R (30.67 [SE 0.3] to 31.2 [SE 0.3]; effect size 0.31) MARS-M (0.65 [SE 0.2] to 0.57 [SE 0.2]; effect size 0.07) No differences on depression or cognitive function

20. Preliminary Efficacy: Symptoms Number of symptoms at exit: –TM group 3.86 (SE 0.05) –Control group 5.26 (SE 0.46) A significant post-intervention difference: p=.04, moderate effect size 0.50

21. Preliminary Efficacy: Adherence Mean weeks of adherence: TM group 5.95 (SE 0.45) Control group 5.95 (SE 0.46) Significant post-intervention difference in Relative Dose Intensity (n=26) –Moderate to Large effect size 0.62

22. Satisfaction (n=37) 97% (n=34) high satisfaction 94% (n=34) TMs were helpful 80% (n=28) helped take medication Recommended: –94% (n=34) for symptom management –86% (n=32) for medication adherence

23. Discussion Demonstrated: –Proof-of-concept: acceptable, feasible, & satisfied –Preliminary efficacy (symptom management & adherence) Found: –Age not related to willingness to TM –Females more likely to TM Patients thought TMs were positive & effective at improving self-care!

24. Limitations Medication adherence measurement challenges. Specialty Pharmacy: Medical records not available to obtain stopping or reducing oral agent dosages.

25. Implications for Practice Generally, known to improve medication adherence and disease management. For cancer patients, TMs could be tailored to drug regimen, making usable for simple or complex dosing. Accessible & easy-to-use.

26. Implications for Research Efficacy testing: next step. Precise measures of adherence needed. Intervention dose must be determined: –Each time medication taken OR once daily weekly or monthly

27. Conclusions Use of cell phones is increasing dramatically and no difference in usage with age. TMs are acceptable & feasible in cancer patients prescribed oral agents for symptom management & medication adherence. TMs may be effective in engaging in behavior change and improving self-care. TMs may be an easy to use mode of delivering health care to large numbers of patients.

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