understanding the barriers and facilitators to adherence to oral chemotherapy in hispanic youth with...
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Understanding the Barriers and Facilitators to Adherence to Oral Chemotherapy in Hispanic Youth with A.L.L.
Wendy Landier, MSN, RN, CPNP
Cynthia Hughes, EdD, RN
Evelyn Calvillo, DNSc, RN
Debbie Briseño-Toomey, MSN, RN, PNP
Nancy Anderson, PhD, RN, FAAN
Smita Bhatia, MD, MPH
Leticia Dominguez, BA, CRA, City of HopeAlex Martinez, BA, CSULA Student Research Assistant
Funded by: City of Hope-CSULA Cancer Collaborative Pilot Project Research Program - 5P20CA118775-02 (Kane)
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Background Acute lymphoblastic leukemia (A.L.L.) is the most
common childhood malignancy Survival rates for A.L.L. have dramatically improved
over the past 40 years
American Cancer Society, 2006
3
53
86
0
10
20
30
40
50
60
70
80
90
% S
urv
ivin
g 5
Years
1960-63 1974-76 1995-2001
Year of Diagnosis
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Hispanic Youth and A.L.L.
5-year survival for Hispanic youth with A.L.L. is significantly lower than that of Caucasian youth
Represents a significant disparity in health outcomes for this minority group
Blood 2002;100(6):1957-1964
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Ethnic Differences in Survival in Childhood A.L.L.
Study nCaucasian
SurvivalHispanic Survival
Bhatia (2002) 8447 72.8+0.6% 65.9+1.5%*
Pollock (2000) 5086 81.9+0.6% 74.9+2.0%*
Kadan-Lottick (2003) 4952 70% 63%*
*p<0.001
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Leukemia Relapse
Relapse of leukemia is still a significant problem in youth with A.L.L. At least 15% will relapse Most who relapse will not survive
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Therapy for A.L.L.
A.L.L. (unlike other pediatric cancers) requires a prolonged “maintenance” phase: Self-/parent-administered oral chemotherapy Taken at home over ~2 years
Significant relationship between systemic exposure to oral antimetabolite chemotherapy and EFS in childhood A.L.L.
N Engl J Med 1990;323(1):17-21
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A.L.L. Therapy: Phases
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Therapy: Maintenance Phase
Goal = to “maintain” remission
Usually antimetabolite-based
Daily oral mercaptopurine (6-MP)
Weekly oral methotrexate
Monthly pulses of:
- IV Vincristine
- Oral glucocorticoid x 5 days(prednisone or dexamethasone)
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Adherence to Therapy
Complex health behavior
Studied in a variety of chronic childhood diseases: Diabetes Asthma Sickle cell disease Cystic fibrosis HIV Cancer
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Adherence to Therapy
“An active, intentional, and responsible process of care, in which the individual
works to maintain his or her health, in close collaboration with healthcare personnel”
J Clin Nurs 2000;9:5-12
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Non-Adherence to Therapy
“When the failure to comply is sufficient to interfere appreciably
with achieving the therapeutic goal”
J Pediatr Hematol Oncol, 2006, 12(28):816
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Measuring Adherence
Self-report (interviews, questionnaires) Pill counts Electronic pill monitoring Drug assays
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Non-Adherence in Pediatric A.L.L.
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Non-Adherence to Therapy
Non-adherence may range from: Complete non-adherence Missed doses Incorrect administration Failure to heed instructions associated with taking
medicine (e.g., do not take with dairy products)
All may potentially affect outcome
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Adherence to Therapy
May be influenced by many factors: Complexity of medication regimen Duration of therapy Medication side effects Psychological and cognitive factors Family structure/dynamics Health beliefs Cultural beliefs Socioeconomic status Communication with/trust in healthcare providers
May include language barriers
Important factors for minority
populations
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Non-Adherence in A.L.L.
Clinically prevalent problem Potentially modifiable May increase risk of relapse May contribute to disparity in
survival rates among minority youth
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Current Study:Significance/Rationale
Understanding reasons for non-adherence necessary in order to develop effective interventions to improve adherence
There are currently no reports in literature of: Interventions aimed at improving adherence in
youth with A.L.L. The potential influence of culture on adherence This is despite the large number of studies that
document non-adherence to oral chemotherapy in this population
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Current Study: Significance/Rationale
Address a significant “gap” in current knowledge:
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Current Study: Significance/Rationale
Address a significant “gap” in current knowledge: Reasons for non-adherence in Hispanic youth with
A.L.L. (including influence of acculturation) Lay groundwork for identification and testing of
culturally-relevant and acceptable interventions to improve adherence
Potentially contribute to reduction in current outcome disparity for Hispanic youth with A.L.L.
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Specific Aims
Develop and validate a grounded theory-based model to explain the reasons for non-adherence to oral maintenance chemotherapy in Hispanic youth with A.L.L.
Identify culturally-relevant and acceptable interventional strategies to improve adherence in this group
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Methods
Qualitative (inductive)
Grounded theory Methods of Strauss & Corbin
Designed to examine the process of adherence (and hence the barriers and facilitators)
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Eligibility Criteria
Diagnosis of A.L.L. within the past 10 years at age 21 or younger
Treated at City of Hope Hispanic or Caucasian Received oral antimetabolite chemotherapy for at least
one year during the maintenance phase of therapy Has now completed therapy for A.L.L. English or Spanish speaking Interview participants must be age 12 years or older at
time of study entry
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Study Phases: Year One Individual interviews with:
10 to 20 participants per group (4 groups total)
Purpose: To develop a theoretical model and to identify potential interventional strategies
HispanicPatients
HispanicParents/
Caregivers
CaucasianPatients
CaucasianParents/
CaregiversCaucasians = Referent group
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Study Phases: Year Two Focus groups with selected:
6 to 10 participants/group; 2 – 4 planned groups
Purpose: To validate the theoretical model and identification of potential interventional strategies
HispanicPatients
HispanicParents/
Caregivers
CaucasianPatients
CaucasianParents/
CaregiversCaucasians = Referent group
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Study SchemaInterviews:
Hispanic cohort
Interviews:Caucasian cohort
PatientsParents/
Caregivers
PatientsParents/
Caregivers
Ongoing data analysis
Themes
Themes
Co
mp
are
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Study Schema
Preliminary model to explain adherence Focus Groups:
Validate modelValidate potential
interventions
Fin
al M
od
el
Potential interventional strategies D
ata
an
aly
sis
Disseminate results
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Sampling – Data Saturation
Purposive (theoretical) sampling technique Sample size determined by data saturation:
No new data are emerging Major categories show considerable depth and
breadth Relationships to other categories have been
made clear
Corbin & Strauss, 2008
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Sampling – Data Saturation
Data gathering
Analysis
Analysis
Data gathering
Data gathering
Analysis
Data gathering
Analysis
DataSaturationThe analysis guides the sampling
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Data Collection
Training sessions prior to interviews and focus groups to assure consistency of data collection
Interviews and focus groups audiotaped Transcribed verbatim Translated and back-translated (if Spanish)
Investigator field notes
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Data Collection: Demographics
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Data Collection: Acculturation
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Data CollectionInterview: Sample Questions “Tell me a little about your family. . .who lived at
home when you were (your child was) in the maintenance phase of treatment for leukemia.”
“What was your (your child’s) experience like during this treatment phase?”
“What did you (your child) find difficult about this treatment?”
“Tell me about the pills that you (your child) took during this time.”
“Tell me about any problems you had (your child had) taking the pills or remembering to take the pills during the maintenance phase of treatment.”
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Data CollectionFocus Groups: Sample Questions
From our individual interviews with all of our participants, we learned that these (.......)were the most difficult (most helpful) things about taking your (your child’s) medications during treatment. How would you respond to this?
From our individual interviews with all of our participants, the following ideas about what would help you (your child) and your families to take medication during the maintenance phase of leukemia treatment were (……) How would you respond to this?
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Data Analysis
Ongoing throughout study Periodic meetings of research team Simultaneous data coding and analysis Identification of key concepts/core variables Guided by expertise of Dr. Nancy Anderson
(UCLA School of Nursing)
Corbin & Strauss, 2008
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Data Analysis
Qualitative software (Atlas.ti) to facilitate process Allows data to be viewed from various
perspectives Allows relationships to be tested Provides audit trail
Corbin & Strauss, 2008
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Final End Products
A culturally appropriate, valid, and acceptable theoretical model to explain reasons for non-adherence to oral chemotherapy in Hispanic youth with A.L.L.
Culturally appropriate, valid, and acceptable interventional strategies aimed at improving adherence in this high-risk group
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Understanding the Barriers and Facilitators to Adherence to Oral Chemotherapy in Hispanic Youth with A.L.L.
Progress Report
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Eligibility by Race
n = 88
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Eligibility by Race
Caucasian Hispanic Total
Eligible 30 34 64
Ineligible 10 14 24
Total 40 48 88
20/24 ineligible patients = s/p HCT*
*HCT = Hematopoietic cell transplant
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Ineligibility Reasons
Reason Caucasian Hispanic Total
Not enough/ no 6MP 7 9 16
Relapsed/ on treatment 2 3 5
Too sick 0 1 1
Wrong dx 1 0 1
Deceased 0 1 1
Total 10 14 24
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Eligible Patients
HCT Status/Age Caucasian Hispanic Total
Non-HCT <12 10 11 21
Non-HCT >12 15 16 31
Non-HCT Total 25 26 51
HCT <12 0 4 4
HCT >12 5 4 9
HCT Total 5 8 13
Total 10 14 64
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Interviews Completed to Date
Caucasian Hispanic Total
Parent/Caregiver 2 1 3
Patient 0 2 2
Total 2 3 5
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A brief look at some preliminary data . . .
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“Tell me about any problems you had taking or remembering to take the pills”
“I have a theory that if you take all your meds at a certain time it’ll work for that certain time and then if you don’t take it at that certain time then it’ll work differently. I always had in mind, and it was always in my head bugging me, ‘oh, take your meds, take your meds’...knowing the fact that it was best for me and for my health, that’s really the reason why I always was – had time – to take my meds.”
19 year old Hispanic male with A.L.L.
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“What helped you take your medicines?”
“I think the pill box ...especially helps, like having everything organized for you, definitely helps you remember, helps you know which ones to take.”
16 year old Hispanic female with A.L.L.
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“Do you have any other suggestions or ideas?”
“Make them taste better (laughs), ‘cause like when you leave them in your mouth too long, it would disintegrate and taste so bad.”
16 year old Hispanic female with A.L.L.
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“What did you (your child) find difficult about this treatment?”
“This is the problem, if you’re talking specifically about 6MP, I was told that she should not take it with milk products and that she should not take it with food...and at the time she didn’t have a whole lot of energy and she’d eat, and then she’d fall asleep...”
Mother of 3-year-old Caucasian girl with A.L.L.
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“What did you (your child) find difficult about this treatment?”
“...So I would wake her up, pull her out of bed, and she’d be tired, and it would take me a really long time to wake her up. And I’d put her in the kitchen and shake her and say ‘you’ve got to take this pill,’ and ‘No, no, I’m not taking it!’ And we’d go in this argument and I’d say ‘Well, you ate and I just can’t give it to you, and you had milk.’ And so finally we’d battle it out and she’d take it, put her right back to sleep and she’d fall asleep. And that was the worst part of my life, because I was up all night.”
Mother of 3-year-old Caucasian girl with A.L.L.