(POSTER
PRESENTATION) THE
ASSOCIATION BETWEEN AGE AND GENDER AND THE FINANCIAL BURDEN IN CANCER
PATIENTS: A POOLED ANALYSIS OF CLOSED EORTC CANCER TRIALS.
Chantal
Quinten, John Maringwa, Francesca Martinelli, Corneel Coens, Quality
of Life, EORTC, Brussels, Belgium, Charles S. Cleeland, Symptom
Research, University of Texas, Houston, Texas, Henning Flechtner,
Child and Adolescent Psychiatry and Psychotherapy, University
Magdeburg, Magdeburg, Germany, Carolyn Gotay, School of Population
and Public Health, University of British Columbia, Vancouver, British
Columbia, Canada, Eva Greimel, Obstetrics and Gynecology, Medical
University Graz, Graz, Austria, Madeleine King, Psycho-oncology
Cooperative Research Group, University of Sydney, Sydney, Australia,
David Osoba, Quality of Life, Quality of Life Consulting, West
Vancouver, British Columbia, Canada, Martin J. Taphoorn, Neurology,
VU Medical Center/Medical Center Haaglanden, Amsterdam/The Hague,
Netherlands, Bryce B. Reeve, Cancer Control and Population Science,
National Cancer Institute, Bethesda, Maryland, Jolie Ringash, The
Princess Margaret Hospital, University of Toronto, Toronto, Canada,
Joseph Schmucker-Von Koch, Medical Ethics, University of Regensburg,
Regensburg, Germany, Joachim Weis, Psychooncology, University of
Freiburg, Freiburg, Germany, Andrew Bottomley, Quality of Life,
EORTC, Brussels, Belgium
AIMS: The
objective of this analysis was to investigate the influence of age
and gender on the financial burden of cancer patients, as evaluated
by the European Organisation for Research and Treatment (EORTC)
QLQ-C30. METHODS:
In 30
EORTC Randomized Controlled Trials patients completed the EORTC
QLQ-C30 at baseline. This includes an item about financial
difficulties caused by physical condition or medical treatment,
scored from 1 (not at all) to 4 (very much). Clinical data including
age (<=60 vs. >60), gender (men vs. women), distant metastasis
(no vs. yes), World Health Organization (WHO) performance status (PS)
(WHO 0-1 vs. WHO 2-3) and cancer site were incorporated into a model
to examine the association of age and gender with financial burden,
adjusted for WHO PS, distant metastasis and cancer site. The
magnitude of financial burden was calculated by dividing the actual
scoring difference by its scale and reported in
percentage. RESULTS: Data
were available for 4,666 male and 2,749 female cancer patients, with
65% older than 60 years. Financial impact of the disease was highly
associated with age, with older patients reporting a lower financial
burden than younger cancer patients (1.51 vs. 1.28, 7.6%, p=<.0001).
Men reported a slightly higher financial burden than females (1.45
vs. 1.42, 0.6%, p=0.006). These gender findings were consistent for
both age groups as interaction between age and gender was found not
significant (p=0.44). Additionally, low PS was associated (1.42 vs
1.64, 7.3%, p=<.0001) with greater financial burden, but this
differed with age (interaction with PS, p=0.005) and gender
(interaction p=0.021). CONCLUSIONS: Age,
gender and performance status are determinants of cancer patients'
financial burden. Less financial burden was experienced by older
people and women with poor performance status. These findings could
be important for supportive care when treating cancer patients,
although more work is needed to interpret the size and importance of
these differentials.
(POSTER
PRESENTATION) MINIMAL
IMPORTANT DIFFERENCES FOR HEALTH RELATED QUALITY OF LIFE SCORES FROM
THE EORTC QLQ-C30 IN LUNG CANCER PATIENTS: ANALYSIS OF POOLED
DATA
John
Maringwa, Chantal Quinten, Francesca Martinelli, Corneel Coens,
Quality of Life, EORTC, Brussels, Belgium, Charles S. Cleeland,
Symptom Research, University of Texas, Houston, Henning Flechtner,
Child and Adolescent Psychiatry and Psychotherapy, University
Magdeburg, Magdeburg, Germany, Carolyn Gotay, School of Population
and Public Health, University of British Columbia, Vancouver, Canada,
Eva Greimel, Obstetrics and Gynecology, Medical University Graz,
Graz, Austria, Madeleine King, Psycho-oncology Co-operative Research
Group, University of Sydney, Sydney, Australia, David Osoba, Quality
of Life, Quality of Life Consulting, West Vancouver, Canada, Martin
J. Taphoorn, Neurology, VU Medical Center/Medical Center Haaglanden,
Amsterdam/The Hague, Netherlands, Bryce B. Reeve, Cancer Control and
Population Science, National Cancer Institute, Bethesda, Jolie
Ringash, The Princess Margaret Hospital, University of Toronto,
Toronto, Canada, Joseph Schmucker-Von Koch, Medical Ethics,
University of Regensburg, Regensburg, Germany, Joachim Weis,
Psycooncology, University of Freiburg, Freiburg, Germany, Giuseppe
Giaccone, Medical Oncology Branch, National Cancer Institute,
Bethesda, Pieter Postmus, Pneumology, Vrije Universiteit Medisch
Centrum, Amsterdam, Netherlands, Egbert F. Smit, Pulmonary Diseases,
Vrije Universiteit VUMC, Amsterdam, Netherlands, Jan Van Meerbeeck,
Thoracic Oncology, Universiteit Gent, Gent, Belgium, Andrew
Bottomley, Quality of Life, EORTC, Brussels, Belgium
AIMS: The
objective is to determine changes in Health Related Quality of Life
(HRQOL) scores on the EORTC QLQ-C30 scales (with range 0-100) which
correspond to the minimal important difference (MID). METHODS:
Two
closed European Organization for Research and Treatment of Cancer
(EORTC) randomized controlled trials enrolling in total 812 advanced
NSCLC cancer patients were jointly analyzed. WHO performance status
(PS) and weight loss (WL) were chosen as clinical anchors for 6 HRQOL
scales of the QLQ-C30 questionnaire; physical (PF), social (SF) and
role (RF) functioning, global health status (GH), fatigue (FA) and
pain (PA). Changes in PS formed 3 groups; improvement, no change, and
deterioration, while changes in weight were grouped as weight loss
and no change. Patients gaining 5% or more weight were excluded.
Analysis of variance was used to compare HRQOL scores between groups.
The differences in the mean of HRQOL score changes between adjacent
groups were used to estimate the MID. RESULTS: 485
(for PS) and 311 (for WL) patients who had both HRQOL and anchor
values on at least 2 maximally separated time points were included
for the analysis. For PS, statistically significant differences
(p<0.05) in HRQOL across groups were noted for all 6 scales, while
for WL significant differences appeared for SF, FA and PA only. Based
on the 2 anchors, the ranges of adjacent group differences were; PF
(4.6-9.9), SF (4.9-10.1), RF (3.7-12.3), GH (3.0-10.2), FA (5.9-15.7)
and PA (2.2-14.8). CONCLUSIONS: Our
results suggest that in patients with advanced NSCLC undergoing
treatment, the functioning scales can be interpreted using a change
in score of 4 to 12 as the MID. For fatigue a change of 6-16 and for
pain 2-15 can be used. These MID estimates are similar to previous
reports. They provide guidelines for classification of patients by
changes in HRQOL and symptoms over time, and may aid sample size
determination for future studies. Further validation in cancer
patients with other diagnoses and other anchors is
planned.
(ORAL
PRESENTATION) A
SYMPTOM INDEX FOR CANCER PATIENTS BASED ON THE QLQ-C30
Francesca
Martinelli, Chantal Quinten, John Maringwa, Corneel Coens, Quality of
Life, EORTC, Brussels, Belgium, Charles Cleeland, Symptom Research,
MD Anderson Cancer Center, Houston, Texas, Henning Flechtner, Child
and Adolescent Psychiatry and Psychotherapy, University of Magdeburg,
Magdeburg, Germany, Carolyn Gotay, School of Population and Public
Health, University of British Columbia, Vancouver, Canada, Eva
Greimel, Obstetrics and Gynecology, Medical University Graz, Graz,
Austria, Madeleine King, Psycho-oncology Co-operative Research Group,
University of Sydney, Sydney, Australia, Tito Mendoza, Toru Okuyama,
Symptom Research, MD Anderson Cancer Center, Houston, Texas, David
Osoba, Quality of Life, Quality of Life Consulting, West Vancouver,
Canada, Bryce Reeve, Cancer Control and Population Science, National
Cancer Institute, Bethesda, Maryland, Jolie Ringash, The Princess
Margaret Hospital, University of Toronto, Toronto, Canada, Joseph
Schmucker-Von Koch, Medical Ethics, University of Regensburg,
Regensburg, Germany, Qiuling Shi, Symptom Research, MD Anderson
Cancer Center, Houston, Texas, Martin Taphoorn, Neurology, Medical
Centre Haaglanden, The Hague, The Netherlands, Xin Wang, Symptom
Research, MD Anderson Cancer Center, Houston, Texas, Joachim Weis,
Psychooncology, University of Freiburg, Freiburg, Germany, Young Yun,
Quality of Cancer Care Branch, National Cancer Center, Goyang, Korea,
Andrew Bottomley, Quality of Life, EORTC, Brussels, Belgium
AIMS: The
aim of this study was to construct a clinically-relevant symptom
index for cancer patients from the EORTC QLQ-C30. METHODS:
The
factor structure of 17 symptom-related items from the QLQ-C30 was
retrospectively explored in 2 MD Anderson datasets: N=252 Japanese
cancer patients (J) and N=177 Korean cancer patients (K). QLQ-C30 and
MD Anderson Symptom Inventory (MDASI) data were available for all
patients. The "square root of the off-diagonal elements of the
residual matrix" was used to select factors, and items with
loadings above 0.5 on selected factors were used to build the index.
The reliability of the index was measured with Cronbach's alpha (a).
Student's t-test was used to compare index scores between subgroups
of patients by metastatic status (no vs yes) and ECOG performance
status (PS, 0-1 vs 2-3-4). Concurrent validity was assessed by
computing Pearson's correlation coefficient (r) between the index and
MDASI items. An external pooled dataset including N=5302 cancer
patients from 32 countries who partecipated in EORTC clinical trials
was used to assess reproducibility and generalizability of the
findings. RESULTS: 11
items met selection criteria and were summed to construct the index:
pain, need to rest, weakness, lack of appetite, nausea, vomiting,
tiredness, difficulty concentrating, worry, irritability and
depression. High reliability (a=0.86 for the J dataset, a=0.91 for
the K dataset) and ability to discriminate by PS (J, p<0.0001; K,
p<0.0001) were seen. The index could discriminate by metastatic
status in the J patients only (p<0.0005). Correlations with most
MDASI items were high: r=0.55-0.75 for the J dataset and 0.54-0.80
for the K dataset. In the external EORTC dataset, the index showed
high reliability (a=0.86) and was able to discriminate patients by
metastatic status (p<0.0001) and WHO PS (p<0.0001). CONCLUSIONS: A
brief, reliable and valid symptom index can be derived from the
QLQ-C30 and used in analysis of clinical trials. Additional research
is planned to understand why some symptoms did not appear in the
index and how those symptoms should be assessed.