The Brno Quality Of Life Longitudinal Study of Pediatric

Oncology Patients (“qolop”) Tomáš Kepák, Marek Blatný, Irena Vlčková,

Milan Pilát, Petra Navrátilová, Martin Jelínek, Šárka Kárová, Jaroslav Štěrba

The Faculty Hospital Brno, The Children's Medical Center, Brno Inst. of Psychology, Czech Academy of Sciences, Brno

Masaryk University, Brno

CEQOL, 01/31/08

Childhood cancer survivors

• The likelihood of a 5-year survival has increased from less than 30% in 1960 to more than 80% today.

• The paradigm in paediatric oncology has changed: towards current expectation of “cure” and survival into adulthood cancer in children is now perceived to be a chronic disease.

• Thus, childhood cancer survivors represent a growing, at-risk population with a need of specialized health-care and psychosocial support.

Cure rates of childhood cancer

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1962–66 1967–71 1972–76 1977–81 1987–91

Year of treatment

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ear

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All cancersGonadal germ cellHodgkin’s

CNSOsteosarcomaAcute lymphoblastic leukaemia

SIGN, 2004 (http://www.sign.ac.uk/guidelines/fulltext/76/section1.html).

1982-86 1992-96

Main causes of success in PO

• Multidisciplinary and centralized approach to the treatment

• Consecutive clinical trials leading to a gradual optimalisation of treatment regimens

• Advances in chemotherapy and irradiation techniques

• Advances in supportive care

– Antimicrobial treatment and haematology supportive care

– Psychosocial support concurrently with surgery, irradiation and chemotherapy

Quality of Life

• Along with the increasing cure rates the QUALITY of SURVIVAL instead of the survival itself has become the marker of cancer treatment success.

• Survivors experience a spectrum of cancer-related morbidity that affects both physical and mental health.

• 2/3 of childhood cancer survivors suffer from at least one of serious late sequalae of the cancer treatment!

(Geenen, JAMA, 2007, Oeffinger, NEJM, 2006)

• Physical problems– Growth– Fertility– Organ function impairements

(heart, lungs, kidneys etc.)– Physical restrictions – Risk of premature onset of

common conditions associated with aging (e.g. Diabetes mellitus, cardiovascular disease, hypertension, hyperlipidemia)

– Risk of premature death

• Psychosocial and Educational problems– PTSD– Learning, memory– Educational achievement– Lack of self-confidence– Compromised opportunities– Social isolation– Social competence– Lower self-image– Lower marital rates– Underemployment– Independent living etc.

PRIZE for CURE survivors´well-being

• There is a continuing international cooperation in Paediatric Oncology (SIOP, COG, UKCCSG, BFM, SFOP …), focusing on late effects and QoL issues.

• QoL is currently being implemented to the clinical trials as the important end-point of new clinical trials (Hodgkins, sarcomas etc.).

• A new research area “Onco-Psychology” has been established.

HOWEVER ….

Paediatric Onco-Psychology

• Still a paucity of research on QoL in children cancer survivors

Prospective longitudinal studies are vital! Complex study design in terms of health, social and

educational issues, parental-child relationship etc.

• Much of the current research with sufficient sample size, appropriate age- and gender-matched controls is prevalently retrospective and focused on particular determinants

(Barrera M. et al, Cancer 2005, De Clercq, J Ped Psych, 2004, Oeffinger K., NEJM 2006, Upton&Eiser, Child Care Health Dev,

2006…)

QoL research challenges

www.qolop.eu

Research on childhood cancer survivors

• current research on the quality of life in children with cancer is facing methodological problems

(Eiser, Hill, Vance, 2000, Wallace et al., 2001, Patenaude, Kupst, 2005, Last, Grootenhuis, Eiser,

2005)

• „qolop“ project designed to meet contemporary requirements on research methodology

Methodological requirements

1. methodology reflecting the multiple-sources & multidimensional nature of ‘quality of life’ (not only HR-QoL)

2. longitudinal research design

3. implementation of developmental approach (changes in the criteria of the quality of life over time)

4. multi-informant perspective

5. systems approach (family, siblings!)

6. comparison with healthy population & other chronic ill children

„qolop“ design...

1. multidimensional nature of ‘quality of life’

MMQL (Bhatia et al., 2002, Bhatia et al., 2004)

• Objective indicators: mobility, sensory functions

• Subjective indicators: moods and feelings, life satisfaction

Methods measuring other determinants of QoL besides health:

• child personality (temperament)

• parent/child relationships

• friends

• social support in general

…„qolop“ design...

2. longitudinal design & developmental approach

Original method controlling sources of QoL:

children assess not only satisfaction, but also

importance (value) of life domains – 30 domains

How important is for you…

…to be healthy, to have good relationships with people, etc.

How are you satisfied with your… …health, relationships with people etc.

…„qolop“ design

3. multi-informant perspective

Information from physicians, children, parent(s)

4. systems approach (family, siblings!)

5. comparison with healthy population & other chronic ill children

Expected sample size = 300 children

(criteria: 2 – 5 years in remission, 8 – 18 years old)

Will be compared with 300 healthy children and 300 chronic ill children (e.g. asthma)

Health and Wellness Questionnaire

A version for survivors and for parents/guardiansAdministered under standard circumstancesTime for completion 45-60 minutes

Components / Domains:• MMQL (HRQoL)• HBSC (dietary habits, physical activities) • CDI (emotion, depression scale)• Modified SQUALA (values + life satisfaction)• SAHA (daily routine, activities, abusus, academic

achievement, family and social relationships)• Social support measure (based on several scales)• NEO-FFI (personality)

Health and Wellness Questionnaire

Study progress of the „qolop“ project

2005 – Interdisciplinary working party for quality of life of children with chronic diseases established in Brno

2006 – the QOLOP (Health and Wellness) Questionnaire constructed

- commencement of the accrual (11/11/06)

2006-2008 Neurocognitive functioning in children cancer survivors (Czech Science Foundation – GACR, No. 406/05/0603)

2007-2010 Quality of life in children surviving cancer (Czech Science Foundation – GACR, No. 406/07/1384)

Study progress of the „qolop“ project

2007 – Center for Quality of Life Clinical Research, Masaryk University in Brno & Czech Academy of Sciences -

CEQOL (www.ceqol.cz)

- collaboration with other centers in the Czech Republic (Prague) and Slovakia (Bratislava)

2008 International collaboration:

Interdisciplinary Research Collaboratory on Cancer and Children (IRCCC), coordinated by Christine and Richard

Eiser, University of Sheffield, UK

Study progress of the „qolop“ project

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Current status (12/2007): • 53 childhood cancer survivors assessed, • 80 children and adolescents with chronic diseases

(asthma bronchiale, locomotor diseases), • 200 matched controls.

Study progress of the „qolop“ project

Too early to draw conclusions regarding QoLExcellent compliance: 53/55 entered (96%)

Future directions: - Validation and standardization of methods (CZE, SK) 2008-2009- QoL not only in survivors but also during treatment

(assessment since diagnosis; palliative setting) since 2009- benefits - post traumatic growth

- Pediatric oncology as a potential model for adult oncology and possibly for other chronic diseases?

The „qolop“ prospective outcomes

• Therapeutic modifications to reduce cancer-related morbidity

• Survivor education based on individual specific treatment risk

• Fact sheets and educational materials for patients and their parents

• Interventions to enhance resilience following cancer experience

• Reccommendations for healthy lifestyle behaviors

• Educational programmes and materials for caregivers - physicians, nurses, psychologists, teachers

Thank you for your attention!

www.qolop.eu