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Patient Beliefs and their
Influence on Adherence to
Oral Anti-Cancer Agents
S. Spoelstra, PhD, RN
Oncology Nursing Society
Advancing Care Through Science
November, 2012
Phoenix, AZ
Barbara A. Given, PhD, RN, FAAN (Co-PI)
University Distinguished Professor and Associate Dean of Research
Michigan State University College of Nursing
Charles W. Given, PhD (Co-PI)
Professor, Michigan State University College of Human Medicine,
Department of Family Medicine
Marcia Grant, DNSc, RN, FAAN (Co-PI)
Director and Professor Nursing Research/Education, City of Hope
Mei You, MS
Statistician, Michigan State University College of Nursing
Grant Award: Adherence to Oral
Chemotherapeutic Agents Research
11/13/2007—11/30/2010
Project Title: An Intervention to Improve
Adherence & Symptoms from Oral Agents
Funding Source: Supported by a research
grant funded by the Oncology Nursing
Society Foundation through an
unrestricted grant from GlaxoSmithKline
Objectives for Presentation
1) To describe how beliefs about oral anticancer agents may influence adherence to
oral anti-cancer agents.
2) To review implications for nurses
regarding patient beliefs and oral anticancer agent adherence.
Problem
• With increased use of oral anti-cancer
agents, patients are responsible for
adhering to complex regimens at home.
• Evidence exists that “beliefs” may
influence medication regimen adherence
in other diseases, such as HIV.
• Beliefs may influence adherence oral
agent in those with cancer.
Framework
• A cognitive behavioral model was the
underpinning of the intervention comparing
the impact of:
– Usual care
– Usual care with strategies to manage
symptoms and adherence,
– Usual care with strategies to manage
adherence alone
Patient
Characteristics
Education
Age
Sex
Income
Race/Ethnicity,
Health insurance
Depressive
symptoms
Baseline/Intake
Interview
-Regimen complexity
(number per days
refills)
-Symptoms
-Out-of-pocket cost to
patient
-Beliefs about
medications (BMQ)
Clinical Factors
Disease & stage
Symptom severity
Treatment protocol
(oral or oral + IV)
R
A
N
D
O
M
I
Z
A
T
I
O
N
ARM-1
AVR Alone
Information from AVR +
SMT +Monitoring
symptoms & adherence
ARM-2
AVR + Nurse
Intervention on
Symptom Management
& Adherence
Monitoring Information
Problem solving
Assessment
ARM-3
AVR + Nurse
Intervention on
Adherence Only
Monitoring Information
Problem solving
Assessment
Improved
Decrease in
Symptom
Severity
Adherence
Symptoms
Acceptability
Satisfaction
Beliefs about
Oral Agents
Specific Aims
I. To describe patient beliefs about oral
anti-cancer agents.
II. To describe how patient beliefs about
oral anti-cancer agents were associated
with adherence to the oral anti-cancer
agent regimen.
Measures
• Symptom Experience Inventory (intake, weekly, & exit)
• Adherence with Oral Agent* (intake, weekly, exit)
– Patient report, medical record audit, specialty pharmacy fill/refill
– collected at baseline, weekly for 8 weeks, and at exit
• CESD-20 (intake)
• Beliefs About Medications* (intake)
– 28 items assessing beliefs about oral agents collected at baseline
– Responses on 5-point scale (strongly disagree to strongly agree )
• Out-of-Pocket Costs (intake)
• Satisfaction with Information & Intervention (exit)
*used in this study
Analyses
• Exploratory factor analysis (EFA)
– Using varimax rotation to assess beliefs items (Aim 1)
• Validation of EFA “Beliefs About Oral
Oncolytic Medication Scale & sub-scales
– Observing rates of oral agent adherence differences
using t-tests, regardless of study arm (Aim 2)
Descriptive Statistics
•
•
•
•
•
Total N = 119
37 men and 82 women
Mean age 61.2 years (SD 13.7) range 28 to 86
76% Caucasian
67% Married, 14 % Widowed, 10% Never
Married
• Education: 26% Some high school, 32% Some
college, 42% Graduate school
Type of Oral Agents N= 119 Number
Capecitabine (Xeloda)
Erlotinib (Tarceva)
Lapatinib (Tykerb)
Imatinib (Gleevec)
Other
Temozolomide (Temodar)
Sunitinib (Sutent)
Sorafenib (Nexavar)
Methotrexate
Cyclophosphamide (Cytoxin)
Percent
42
29
11
9
9
7
6
3
2
1
25% were also receiving concurrent intravenous chemotherapy
35
24
9
8
8
6
5
2.5
1.7
0.8
Results-Aim I
Aim 1: To describe patient beliefs about oral anti-cancer agents.
• 19 of 28 questions on “beliefs” were
retained in EFA model
• The 19-items loaded onto 4-factors:
–
–
–
–
‘Reduce dosing to manage symptoms’ α 0.82 (N=6)
‘Confusion with dosing’ α 0.80 (N=5)
‘Belief in effectiveness of oral agent’ α 0.84 (N=6)
‘Trouble with affordability’ α 0.72 (N=2)
Results-Aim II
Aim II: To describe how patient beliefs about oral anti-cancer agents were
associated with adherence to the oral anti-cancer agent regimen.
Adherence measure # of contacts in AVR1—8:
– Adherence: >7 contacts of adherence were
reported
– Non-Adhere”’ <7 contacts of adherence were
reported
Results-Aim II
Aim II: To describe how patient beliefs about oral anti-cancer agents were
associated with adherence to the oral anti-cancer agent regimen.
• Differences in adherence groups for:
– ‘Confusion with dosing’ (p=0.01*)
• Adherence mean 0.45 (SD 0.51) N=67
• Non-adherence mean 0.76 (SD 0.58) N=33
– ‘Trouble with affordability’ (p=0.00*)
• Adherence mean 0.85 (SD 0.89) N=58
• Non-adherence mean 1.55 (SD 1.21) N=29
Results-Aim II
Aim II: To describe how patient beliefs about oral anti-cancer agents were
associated with adherence to the oral anti-cancer agent regimen.
• No differences in adherence groups for:
– ‘Reduces dosing to manage symptoms’ (p=0. 92)
• Adherence mean 0.65 (SD 0.72) N=67
• Non-adherence mean 0.63 (SD 0.43) N=31
– ‘Belief in effectiveness of oral agent’ (p=0. 71)
• Adherence mean 2.97 (SD 0.66) N=67
• Non-adherence mean 2.92 (SD 0.69) N=33
Conclusion
• Patients who believed they were less
confused about the regimen dosing
schedule or had fewer affordability
problems, were more likely to adhere
to oral agents.
– This has been further supported by literature
since this study was completed.
Implications for Nursing
• Nurses should provide detailed written and
verbal information on the oral agent
regimen dosing schedule to patients.
• Nurses need to confirm patient
understanding of the regimen, to assure
understanding and reduce confusion with
dosing.
Implications for Nursing
• Affordability with oral agents should be
assessed for each patients.
• Assistance with payment should be sought
from insurers or drug companies, for those
who need it.
Implications for Research
• Interventions directed at reducing patient
confusion about oral agent regimen dosing
and scheduling need to be developed and
tested.
• Future research needs to be directed at
developing a oral agent financial eligibility
assessment for cancer patients, so that
ability to afford the treatment can be
determined prior to prescribing oral agent.
Michigan State University College of Nursing
Bott Building
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