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Patient Reported Outcomes and Quality of life in Children with Cancer

An Introduction to concepts of Patient Reported Outcomes And Quality of Life
by

Tha'er Momani

on 5 May 2015

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Transcript of Patient Reported Outcomes and Quality of life in Children with Cancer

Tha'er G. Momani
Division of Nursing Research

Patient Reported Outcomes & Quality of Life in Children with ALL
The concept of Quality of Life (QOL) is of paramount importance for evaluating quality and outcomes of health care
QOL is a multidimensional, self-perceived construct
Includes: 1)Physical functioning and activity. 2)Psychological adjustment, 3)Social functioning and relationships, and 4)Overall sense of well-being
Measurement of QOL must be from the perspective of the child, adolescent, and family
Must be sensitive to the changes that occur throughout development.
What is Quality of Life?
The Food and Drug Association (FDA) defines a patient reported outcome (PRO):
“A measurement of any aspect of a patient’s health status that comes directly from the patient, i.e. without the interpretation of the patient’s responses by a physician or anyone else"
An umbrella term that covers a whole range of potential types of measurement.
Used specifically to refer to self-reports by the patient.
PRO data may be collected via self-administered questionnaires completed by the patient themselves or via interviews.
Patient Reported Outcomes (PRO)
Why study Quality Of life??
Generic:
Comparisons between different groups of children, such as between children with cancer and children in the general population.
Population norms exist that facilitate the interpretation of results.
Generalizable.
May not address symptoms important to patients with cancer,
May not be responsive to disease-specific interventions

Disease-specific:
More responsive to disease-related changes in QOL.
Do not facilitate comparisons between children with and without cancer.

Modular:
Combine elements of generic and disease-specific scales.
A generic or core questionnaire that is applicable to a wide group of patients +
Specific modules designed to assess topics of relevance to cancer
How do we measure QOL?
Studies of QOL
Qualitative
Quantitative
The Good Day Study
QOL in Children with Cancer
2 Questions!
What Makes a Good Day For You?
How Has Being Sick Been for You?
A Longitudinal study of QOL in children as they progress in treatment and till they are off treatment
A sample of 760 children ages 2-18
2 Instruments:

PedsQL Generic 4.0
PedsQL Cancer 3.0
Different Diagnoses:
Hodgkin's Lymphoma
AML
Osteosarcoma
DIPG
ALL
Melanoma
Brain Gliomas
Do Usual/Go Places/Be Normal/At Home
No Sick/More Rest/Energy
No Hospital/Short Stay/Smooth
Good Mood/ Meanfl. Interactions
Boring/can’t do what I want
Good/Good Change/Good Place
New Experience/Not expected
Cont.
Cont.
Risk
Risk
Age
Age
Gender
Gender
Time
Time
Family/Friends
Being Able to Eat
Benefit/Energy
Not Sure
Just live / Spirit
No Friend/No Home/No like
Not bad/Used to it
Trust in God/Good thought
Children were more likely to state a good day as “doing usual” (p<.008).

“Playing my video games and watching TV and running around playing with her [my little sister]”
Adolescents stressed on “not being sick” (p<.005) as making a good day, when compared to children

“Not having to go to the hospital”
“Everything going right. No complications”
Adolescents had a higher emphasis on “being normal” (p<.005)

“When I feel like a normal kid.”

“When I do not hurt or ache. When my life becomes close to normal or feel normal”
Females in comparison to males emphasized a good day as “not being sick” (p<.005).

“When I feel good, when I can play, when I laugh a lot, not having to be here [St. Jude] all the time”
Females in comparison to males emphasized having “energy” (p=.048).

“Having lots of energy, being able to go out places, not feeling nauseated, seeing my friends and my sister”
“not being sick” was correlated with standard/high risk arm of therapy (p=.021).

“Just if nothing goes wrong--like no bad muscle cramps, no joint pain, no headaches. You know, just doing okay”

“When I have no pain in my neck. Days like this--it just felt like a good day”
What's Next?
Adolescents expressed that being sick had changed their lives more than children (p=< .005).

“It has actually made me a better person. I have always been tense, angry and selfish. I feel I need my family more. I'm more emotional, I cry more (teary eyed). I just have a better attitude towards life.
Adolescents saw it as a new experience more than children (p=.004).

“Being sick has really changed my life a lot. The medicine makes you very emotional so you cry a lot and have mood swings and have good days and bad days”

“An unforgettable experience”
Adolescents stressed "missing home" (p<.016) more than children.

“I miss my house because I haven't been able to see it in two months. I miss my normal life, friends, family school and being at home.”
Allocating health care resources, determining reimbursements policies.
QOL had more predictive power than indicators of tumor burden and tumor response.
QOL scores was a significant predictor of the length of survival.
Equally effective Treatments may require QOL as key determinant of treatment .
When one treatment produces better survival but is more toxic, when average survival is short.
Palliative treatments that extends life while impairing QOL!!.
To understand how an existing or novel treatment impacts an individual’s functioning in the context of any improvement to survival.
The pharmaceutical industry include QOL scales into phase II to phase IV trials
In pediatric oncology, successful treatment resulted in neuropsychological late effects, leading to discussing how much effective is a treatment if it results in a lifelong low QOL.
Types of QOL Instruments
Generic:
The Pediatric Quality of Life Scale (PedsQL) Generic Core Scale v 4.0
23-item multidimensional scales encompass 4 domains:
1) Physical functioning (8 items).
2) Emotional functioning (5 items).
3) Social functioning (5 items).
4) School functioning (5 items).
Modular:

The Pediatric Quality of Life Scale (PedsQL) Cancer Module v 3.0

Parallel child self-report and parent proxy-report.
Child self-report: 5–7 years (young child), 8–12 years (child), and 13–18 years (adolescent).
Parent proxy-report: 2–4 years (toddler), 5–7 years (young child), 8–12 years (child), and 13–18 years (adolescent).
Examples
mHealth
CAT
Computer Adaptive Test
Patient Reported Outcomes Measurement Information System (PROMIS).
Funded by the National Institutes of Health (NIH)
CAT provides instant personal health status report on up to nine different areas (or domains) of health.
CAT works by choosing the questions in each area that are best to patient based on answers to earlier questions.
Each area takes 1–2 minutes to complete.
CAT measures how patient's health compares to the general public and/or people who are similar to in age and gender and "diagnosis".
Aim 1
The project aims to report and measure difference and changes in QoL:

Variables include:
Diagnosis.
Gender;
Age: 1)Toddler 2-4; 2)Young Child 5-7, 3)Child 8-12, and 4)Adolescent 13-18 years.
Time of treatment.
Risk Arm: High Risk/Moderate Risk Vs. Low Risk.
Aim 2
Use an advanced statistical analysis technique, structural equation modeling (SEM).
This will help us on two domains of QoL:
1) Causal modeling, or path analysis, to find causal relationships among variables and test the causal model with a linear equation system, which will allow us to study manifest and latent variables that can affect QoL in our population.
2) Confirmatory factor analysis, where we will be using a proposed QoL in children model and apply it to our population, to test the model and define further aspects that can affect our population’s QoL.
Adolescents expressed having "Energy" as making a good day for them more frequently than children (P< .0005)
More Children saw a "Benefit" from their treatment than adolescents (p< .049)
Children expressed that they were "fine" more frequently (p< .026)
Males had more emphasis on "Doing Usual" more frequently (p< .018)
Males cited a "short stay" as making a good day more frequently (p< .024)
Males expressed seeing more "Benefit" in their treatment (P < .049)
"Energy" was more frequently mentioned in the High/Standard Arm (p< .008)
"Short Stay" significantly decreased through each time point (P< .0001)

T1:4.1%
T4: 0%
" No Hospital" Decreased significantly (P < .0001)

T1: 10.1%
T6: 0%
" No Sick" (P< .001)

T1: 16.2%
T6: 8.1%
Males more frequently said it was "Not Bad"
(P< .0001)
Females said it was " Bad Hard" more frequently (P< .002)
Males described being "At the Hospital" more frequently (P< .006)
Females mentioned "Can't Do" more frequently (p< .009)
Females mentioned it was "Harder" more frequently (p< .022)
Females saw it as a "Good Change" more frequently (p< .024)
Females mentioned "No Friends" more frequently (p< .038)
Females mentioned "Bad Sick" more frequently (p< .39)
Children expressed more frequently getting "Benefit" from treatment (p< .021)
The High/Standard Risk arm reported significantly more "Hard" than the Low Risk arm (p< .0001)
"No Home" significantly decreased as patients progressed in their treatment (p< .0001)

T1: 5.8%
T4: 0%
Design
Cell phones are always available and ready to go.
Reduces site preparation and training burden
Patients already know how to use their own mobile phone.
As easy as using any application.
Fast to deploy, requires minimal sponsor involvement/time
Rapid rollout and clinical trial data lock
Real-time analysis
No hardware costs
No complex devices to manage, buy, ship, import/export.
www.nihpromis.org
Quality of life (QOL) in pediatric oncology is multidimensional. It includes, but is not limited to, the social, physical, and emotional functioning of the child and adolescent, and when indicated, his/her family.
"American Cancer Society"
Fatigue, Sleep, Stress, Quality of Life, Anger, Anxiety, Depression, Pain Behavior, Pain Interference
Mobile Health
Code Book: 52 Codes
Total Patients= 150
Number of coded text: 2200 codes
ALL
Total XV
2002 - 2012
6 time points
The Family
Questions?
Parent Proxy Report
Child Report
Jamie
Dr. Mandrell
Linda
Nancy
Teresa
Michele
Division of Nursing Research
+ Emily
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