outline_expanded.htm

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 Brise–o-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

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

Ethnic Differences in Survival in Childhood A.L.L.
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

Therapy for A.L.L.
A.L.L. (unlike other pediatric cancers) requires a prolonged ÒmaintenanceÓ 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.

A.L.L. Therapy: Phases
Therapy: Maintenance Phase
Goal = to ÒmaintainÓ 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
ÒAn active, intentional, and responsible process of care, in which the individual works to maintain his or her health, in close collaboration with healthcare personnelÓ

Non-Adherence to Therapy
ÒWhen the failure to comply is sufficient to interfere appreciably with achieving the therapeutic goalÓ

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:
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:
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

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

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 ÒgapÓ in current knowledge:

Current Study:
Significance/Rationale
Address a significant ÒgapÓ 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 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

Methods
Qualitative (inductive)
Grounded theory
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:
10 to 20 participants per group (4 groups total)

Study Phases: Year Two
Focus groups with selected:
6 to 10 participants/group; 2 – 4 planned groups

Study Schema
Study Schema

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

Sampling – Data Saturation
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

Data Collection: Demographics
Data Collection: Acculturation
Data Collection
Interview: Sample Questions
ÒTell me a little about your family. . .who lived at home when you were (your child was) in the maintenance phase of treatment for leukemia.Ó
ÒWhat was your (your childÕs) experience like during this treatment phase?Ó
ÒWhat did you (your child) find difficult about this treatment?Ó
ÒTell me about the pills that you (your child) took during this time.Ó
ÒTell me about any problems you had (your child had) taking the pills or remembering to take the pills during the maintenance phase of treatment.Ó

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 childÕs) 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 (ÉÉ) How would you respond to this?

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)

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

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

Understanding the
Barriers and Facilitators to
Adherence to Oral Chemotherapy
in Hispanic Youth with A.L.L.
Progress Report

Eligibility by Race
Eligibility by Race
Ineligibility Reasons
Eligible Patients
Interviews Completed to Date
Slide 43
ÒTell me about any problems you had taking or remembering to take the pillsÓ
  ÒI have a theory that if you take all your meds at a certain time itÕll work for that certain time and then if you donÕt take it at that certain time then itÕll work differently.  I always had in mind, and it was always in my head bugging me, Ôoh, take your meds, take your medsÕ...knowing the fact that it was best for me and for my health, thatÕs really the reason why I always was – had time – to take my meds.Ó

ÒWhat helped you take your medicines?Ó
  ÒI think the pill box ...especially helps, like having everything organized for you, definitely helps you remember, helps you know which ones to take.Ó

ÒDo you have any other suggestions or ideas?Ó
  ÒMake them taste better (laughs), Ôcause like when you leave them in your mouth too long, it would disintegrate and taste so bad.Ó

ÒWhat did you (your child) find difficult about this treatment?Ó
ÒThis is the problem, if youÕre 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 didnÕt have a whole lot of energy and sheÕd eat, and then sheÕd fall asleep...Ó

ÒWhat did you (your child) find difficult about this treatment?Ó
Ò...So I would wake her up, pull her out of bed, and sheÕd be tired, and it would take me a really long time to wake her up.  And IÕd put her in the kitchen and shake her and say ÔyouÕve got to take this pill,Õ and ÔNo, no, IÕm not taking it!Õ And weÕd go in this argument and IÕd say ÔWell, you ate and I just canÕt give it to you, and you had milk.Õ And so finally weÕd battle it out and sheÕd take it, put her right back to sleep and sheÕd fall asleep.  And that was the worst part of my life, because I was up all night.Ó