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)

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

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.

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

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 “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: 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

Important factors for minority

populations

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 “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 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)

Purpose: To develop a theoretical model and to identify potential interventional strategies

HispanicPatients

HispanicParents/

Caregivers

CaucasianPatients

CaucasianParents/

CaregiversCaucasians = Referent group

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

Study SchemaInterviews:

Hispanic cohort

Interviews:Caucasian cohort

PatientsParents/

Caregivers

PatientsParents/

Caregivers

Ongoing data analysis

Themes

Themes

Co

mp

are

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

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

Sampling – Data Saturation

Data gathering

Analysis

Analysis

Data gathering

Data gathering

Analysis

Data gathering

Analysis

DataSaturationThe analysis guides the sampling

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 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.”

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?

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

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

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

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

Total 10 14 24

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

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.