1. 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

2. Barbara A. Given, PhD, RN, FAAN (Co-PI) Charles W. Given, PhD (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

3. 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

4. Objectives for Presentation
1) To describe how beliefs about oral anti-cancer agents may influence adherence to oral anti-cancer agents.
 2) To review implications for nurses regarding patient beliefs and oral anti-cancer agent adherence.

5. 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.

6. 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

7. R A N D O M I Z T ARM-1 AVR Alone
Information from AVR + SMT +Monitoring symptoms & adherence R A N D O M I Z T
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)
Patient Characteristics
Education
Age
Sex
Income Race/Ethnicity, Health insurance
Depressive symptoms
Improved
Adherence
Symptoms
Acceptability
Satisfaction
Beliefs about Oral Agents
ARM-2
AVR + Nurse Intervention on Symptom Management & Adherence
Monitoring Information
Problem solving
Assessment
Decrease in Symptom Severity
ARM-3
AVR + Nurse Intervention on Adherence Only
Monitoring Information
Problem solving
Assessment

8. Specific Aims
To describe patient beliefs about oral anti-cancer agents.
To describe how patient beliefs about oral anti-cancer agents were associated with adherence to the oral anti-cancer agent regimen.

9. 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

10. 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)

11. 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

12. J:\Productivity\Presentations\Powerpoint Presentations\2010\Boston April 2010\Dana Farber April djl.pptx

13. Type of Oral Agents N= 119 Number Percent Capecitabine (Xeloda) 42 35
Erlotinib (Tarceva) 29 24
Lapatinib (Tykerb) 11 9
Imatinib (Gleevec) 8
Other
Temozolomide (Temodar) 7 6
Sunitinib (Sutent) 5
Sorafenib (Nexavar) 3
2.5
Methotrexate 2
1.7
Cyclophosphamide (Cytoxin) 1
0.8
25% were also receiving concurrent intravenous chemotherapy

14. Aim 1: To describe patient beliefs about oral anti-cancer agents.
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)

15. Results-Aim II Adherence measure # of contacts in AVR1—8:
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

16. Results-Aim II Differences in adherence groups for:
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 (SD 0.58) N=33
‘Trouble with affordability’ (p=0.00*)
Adherence mean 0.85 (SD 0.89) N=58
Non-adherence mean (SD 1.21) N=29

17. Results-Aim II No differences in adherence groups for:
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 (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 (SD 0.69) N=33

18. 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.

19. 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.

20. 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.

21. 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.

22. Michigan State University College of Nursing Bott Building
For Nursing Education and Research