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
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
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
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.
Background & Significance
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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.
• 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.
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.
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)
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
Intervention
• Automated platform:
– Timed to medication regimen (just-in-time), 2-way messages
• TMs: 160 characters; theory driven using
motivation & self-efficacy scripts
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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
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
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)
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
Conditions
• Comorbidity mean 1.51 (SD 1.38)
• Cancer site:
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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)
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
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)
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
Type of TM Sent to Patient
Number
TM Sent
Welcome to the study
53
Medication reminders
1,111
Timed to medication
810
Repeated, wrong response after TM sent
301
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
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
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
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
Satisfaction (n=37)
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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
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!
Limitations
• Medication adherence measurement
challenges.
• Specialty Pharmacy: Medical records not
available to obtain stopping or reducing
oral agent dosages.
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.
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
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.
References
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