Transcript Hispanic Youth and ALL

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 Hope
Alex Martinez, BA, CSULA Student Research Assistant
Funded by: City of Hope-CSULA Cancer Collaborative Pilot
Project Research Program - 5P20CA118775-02 (Kane)
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
86
90
% Surviving 5 Years

80
70
60
53
50
40
30
20
10
0
3
1960-63
1974-76
1995-2001
Year of Diagnosis
American Cancer Society, 2006
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
Ethnic Differences in Survival
in Childhood A.L.L.
n
Caucasian
Survival
Hispanic
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%*
Study
*p<0.001
Leukemia Relapse

Relapse of leukemia is still a significant
problem in youth with A.L.L.

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At least 15% will relapse
Most who relapse will not survive
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
A.L.L. Therapy: Phases
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)
Adherence to Therapy

Complex health behavior

Studied in a variety of chronic
childhood diseases:






Diabetes
Asthma
Sickle cell disease
Cystic fibrosis
HIV
Cancer
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
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
Measuring Adherence




Self-report (interviews, questionnaires)
Pill counts
Electronic pill monitoring
Drug assays
Non-Adherence in Pediatric A.L.L.
Non-Adherence to Therapy

Non-adherence may range from:




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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
Adherence to Therapy

May be influenced by many factors:

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Complexity of medication regimen
Duration of therapy
Important
factors for
Medication side effects
minority
Psychological and cognitive factors
populations
Family structure/dynamics
Health beliefs
Cultural beliefs
Socioeconomic status
Communication with/trust in healthcare providers
 May include language barriers
Non-Adherence in A.L.L.


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Clinically prevalent problem
Potentially modifiable
May increase risk of relapse
May contribute to disparity in
survival rates among minority
youth
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
Current Study:
Significance/Rationale

Address a significant “gap” in current knowledge:
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.
Specific Aims

Develop and validate a grounded theorybased model to explain the reasons for nonadherence to oral maintenance
chemotherapy in Hispanic youth with A.L.L.

Identify culturally-relevant and acceptable
interventional strategies to improve
adherence in this group
Methods
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Qualitative (inductive)
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Grounded theory

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Methods of Strauss & Corbin
Designed to examine the process of
adherence (and hence the barriers and
facilitators)
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
Study Phases: Year One

Individual interviews with:
Hispanic
Patients
Caucasian
Patients

Hispanic
Parents/
Caregivers
Caucasian
Parents/
Caregivers
Caucasians = Referent group
10 to 20 participants per group (4 groups total)
Purpose: To develop a theoretical model and to
identify potential interventional strategies
Study Phases: Year Two

Focus groups with selected:
Hispanic
Patients
Caucasian
Patients

Hispanic
Parents/
Caregivers
Caucasian
Parents/
Caregivers
Caucasians = Referent group
6 to 10 participants/group; 2 – 4 planned groups
Purpose: To validate the theoretical model and
identification of potential interventional strategies
Study Schema
Interviews:
Hispanic cohort
Parents/
Caregivers
Compare
Patients
Themes
Ongoing data analysis
Interviews:
Caucasian cohort
Patients
Parents/
Caregivers
Themes
Potential interventional
strategies
Focus Groups:
Validate model
Validate potential
interventions
Disseminate results
Final Model
Preliminary model to
explain adherence
Data analysis
Study Schema
Sampling – Data Saturation
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Purposive (theoretical) sampling technique
Sample size determined by data saturation:
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No new data are emerging
Major categories show considerable depth and
breadth
Relationships to other categories have been
made clear
Corbin & Strauss, 2008
Sampling – Data Saturation
Data gathering
Data gathering
Analysis
Analysis
Data gathering
Data gathering
Analysis
Analysis
Data
Saturation
Data Collection

Training sessions prior to interviews and
focus groups to assure consistency of data
collection
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Interviews and focus groups audiotaped
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
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Transcribed verbatim
Translated and back-translated (if Spanish)
Investigator field notes
Data Collection: Demographics
Data Collection: Acculturation
Data Collection
Interview: 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?”
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“Tell me about the pills that you (your child) took
during this time.”
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“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.”
Data Collection
Focus 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?
Data Analysis
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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
Data Analysis

Qualitative software (Atlas.ti) to facilitate
process

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Allows data to be viewed from various
perspectives
Allows relationships to be tested
Provides audit trail
Corbin & Strauss, 2008
Final End Products

A culturally appropriate, valid, and acceptable
theoretical model to explain reasons for nonadherence 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
Understanding the
Barriers and Facilitators to
Adherence to Oral Chemotherapy
in Hispanic Youth with A.L.L.
Progress Report
Eligibility by Race
n = 88
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
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
10
14
24
Total
Eligible Patients
HCT Status/Age
Non-HCT <12
Non-HCT >12
Caucasian Hispanic Total
10
11
21
15
16
31
Non-HCT Total
HCT <12
HCT >12
HCT Total
25
0
5
5
26
4
4
8
51
4
9
13
Total
10
14
64
Interviews Completed to Date
Caucasian
Hispanic
Total
Parent/Caregiver
2
1
3
Patient
0
2
2
Total
2
3
5
A brief look at some
preliminary data . . .
“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.
“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.
“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.
“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.
“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.