Determination of Cutpoints for Low and High Number
of Symptoms in Patients with Advanced Cancer
Stephanie Gilbertson-White, R.N., Ph.D.,1Bradley E. Aouizerat, Ph.D., M.A.S.,1Thierry Jahan, M.D.,2
Steven M. Paul, Ph.D., Claudia West, R.N., M.S.,1Karen Schumacher, R.N., Ph.D.,3
Marylin J. Dodd, R.N., Ph.D.,1Michael Rabow, M.D.,2
Ahmad H. Abu Raddaha, R.N., M.S.N., Ph.D.,1and Christine Miaskowski, R.N., Ph.D., FAAN1
While patients with advanced cancer experience a wide range of symptoms, no work has been done to deter-
mine an optimal cutpoint for a low versus a high number of symptoms. Analytic approaches that established
clinically meaningful cutpoints for the severity of cancer pain and fatigue provided the foundation for this study.
The purpose of this study was to determine the optimal cutpoint for low and high numbers of symptoms using a
range of potential cutpoints and to determine if those cutpoints distinguished between the two symptom groups
on demographic and clinical characteristics and depression, anxiety, and quality of life (QOL). Patients with
advanced cancer (n=110) completed a symptom assessment scale, and measures of depression, anxiety, and
QOL. Combinations of cutpoints were tested to yield one- and two-cutpoint solutions. Using analysis of variance
for QOL scores, the F-ratio that indicated the highest between-group difference was determined to be the
optimal cutpoint between low and high number of symptoms. A cutpoint of £12 symptoms (i.e., 0–12 is low,
13–32 is high) was the optimal cutpoint for total number of symptoms. Significant differences in depression,
anxiety, and QOL scores validated this cutpoint. Psychological symptoms had higher occurrence rates in the
high symptom group. Findings suggest that a threshold exists between a low and a high number of symptoms in
patients with advanced cancer. Psychological symptoms were significantly different between patients in the low
versus high symptom groups and may play an important role in QOL outcomes in patients with advanced
moderate, and severe pain in oncology patients.1Since 1995,
several studies refined these cutpoints for acute,2,3chronic,4
and cancer5pain and established cutpoints for cancer-related
fatigue.6Cutpoints were created based on the idea that within
the symptom experience, symptom severity comprised the
internal sensory dimension and interference caused by
symptoms comprised the external reactive dimension.1The
nonlinear relationship between severity and interference with
function was demonstrated by a statistically significant
‘‘jump’’ in interference scores as symptom severity went from
mild to moderate or moderate to severe.1–5
Clinically meaningful cutpoints have served as a founda-
tion for treatment guidelines. For example, the National
erlin and colleagues provided evidence to support the
establishment of clinically meaningful cutpoints for mild,
Comprehesive Cancer Network used these cutpoints to es-
tablish treatment algorithms for cancer pain7and fatigue
if management strategies are effective.7
Findings from recent reviews suggest that patients with
advanced cancer experience numerous concurrent symp-
toms.9,10Across 46 studies, 24 different symptoms occurred
in ‡20% of the pooled samples. While total number of
symptoms was not examined as a factor that contributes to
significant decrements in quality of life (QOL), various com-
ponents of this concept of symptom burden11,12(e.g., symp-
tom severity13,14and symptom distress15,16) were associated
with significant decreases in functional status and QOL. In
addition, symptom assessment is a clinically meaningful
proxy for QOL and an extremely reliable patient reported
outcome.11,17Therefore, it is reasonable to suggest that QOL
could be used as an outcome to evaluate clinically meaningful
Schools of1Nursing and2Medicine, University of California, San Francisco, California.
3College of Nursing, University of Nebraska Medical Center, Omaha, Nebraska.
Accepted April 25, 2012.
JOURNAL OF PALLIATIVE MEDICINE
Volume 15, Number 9, 2012
ª Mary Ann Liebert, Inc.
cutpoints for low and high number of symptoms in patients
with advanced cancer. In addition, given that patients with
advanced cancer report more symptoms than patients with
earlier-stage disease,9,18and comprehensive, multidimen-
sional symptom assessment tools may be burdensome for
patients and clinicians, the determination of a cutpoint for
number of symptoms might have some clinical utility. Rou-
tine screening with a symptom checklist could determine a
patient’s total numberofsymptoms.Thenclinicians coulduse
a low/high cutpoint to identify high-risk patients who war-
rant more-in-depth assessments and/or more-aggressive
symptom management interventions.
Expanding on Serlin and colleagues’ idea,1in this study
total number of symptoms was viewed as the sensory di-
mension of the symptom experience, and QOL was viewed as
the reactive dimension. If total number of symptoms has a
nonlinear relationship with QOL (as does pain severity and
interference), then a significant jump in QOL scores would
occur as the total number of symptoms goes from low to high.
Said another way, clinically meaningful differences in total
number of symptoms would be associated with significant
differences in QOL. This hypothesis is supported by clinical
observations in which patients with advanced cancer manage
relatively well with a ‘‘low’’ number of symptoms. However,
when the total number of symptoms crosses some threshold
between low and high, various QOL domains are impaired
and symptom management interventions are not effective.
Therefore, the purposes of this study, in a sample of patients
for low and high number of symptoms using a range of po-
tential cutpoints and to determine if those cutpoints distin-
guished between the symptom groups in any demographic
and clinical characteristics as well as in depression, anxiety,
Design and sample
This descriptive study of 110 patients is part of an ongoing
randomized clinical trial that will determine the efficacy of
two different doses of a psychoeducational intervention to
improve cancer pain management. Patients were included if
they: were adult oncology outpatients (‡18 years of age)
experiencing cancer pain of somatic or visceral origin; were
able to read, write, and understand English; agreed to par-
ticipate and provided written informed consent; had a Kar-
nofsky Performance Status (KPS) score of ‡50; had an
average pain intensity score of ‡3.0 on a 0 to 10 numeric
rating scale (NRS); had a life expectancy of ‡6 months; and
had a telephone line. Patients were excluded if they: had
neuropathic cancer pain; had a documented previous or
current psychiatric disorder; or were receiving hospice care,
in order not to interfere with the pain management program
provided by hospice.
Patients were recruited from a comprehensive cancer cen-
ter, two veterans’ affairs hospitals, and four community-
based oncology clinics. They were asked by a clinician at the
site about study participation. If the patient was interested,
the clinician informed the research nurse, who discussed the
study and obtained written informed consent. Questionnaires
were completed in patients’ homes prior to the onset of the
The Patient Information Questionnaire obtained demo-
graphic characteristics and KPS score.19,20The valid and re-
liable Self-Administered Comorbidity Questionnaire (SCQ),
with scores that range from 0 to 39, provided information on
comorbidities.21,22Medical records were reviewed to obtain
information on cancer diagnosis, current treatments, reason
for current treatments, and metastatic sites.
The Memorial Symptom Assessment Scale (MSAS) con-
tains a list of 32 physical and psychological symptoms that
to indicate whether they had experienced each symptom in
the past week (i.e., symptom occurrence). If they had experi-
enced the symptom, they were asked to rate its frequency of
occurrence, severity, and distress. MSAS was developed for
use with oncology patients23,24and has established validity in
palliative care patients.25
Multidimensional Quality of Life Scale–Cancer Version 2
(MQOLS-CA2) is a 33-item instrument that measures five
dimensions of QOL (i.e., psychological well-being, general
physical well-being, nutrition, symptom distress, and inter-
personal well-being).26,27Each item is rated on a 0 to 10 NRS
Table 1. Results of the Cutpoint Analyses for Total
Number of Symptoms Using the Total and Subscale
Scores from the Multidimensional Quality
of Life Scale–Cancer Version 2
analysis of variance
Cutpoints for number
of symptoms per groupRankFRankF
3 11.5433 4.524
2 11.8312 4.893
1028 GILBERTSON-WHITE ET AL.
with higher scores indicating a better QOL. MQOLS-CA2 has
well established validity and reliability.26,27
Measures used to validate cutpoints
The Center for Epidemiologic Studies–Depression (CES-D)
scale consists of 20 items selected to represent the major
symptoms in the clinical syndrome of depression. Higher
scores indicate higher levels of depression. CES-D has well
established concurrent and construct validity.28,29
Spielberger State–Trait Anxiety Inventories (STAI-S and
STAI-T) each consist of 20 items. Scores can range from 20 to
80. Higher scores indicate greater anxiety. STAI-T measures
anindividual’s predisposition to anxiety determined by his or
her personality and estimates how a person generally feels.
STAI-S measures an individual’s transitory emotional re-
sponse to a stressful situation. Both inventories have well
established validity and reliability.30,31
Table 2. Differences in Demographic and Clinical Characteristics
between the Low (n=43) and High (n=67) Total Number of Symptom Groups
Low symptom group
High symptom group
Mean (SD) Characteristic
Total number of symptoms
Number of metastatic sites
Fisher’s exact test
Two primary cancers
Number of cancer treatments
Reason for current treatment
Kendall’s tau= -.057; .538
Kendall’s tau=.030; .724
KPS, Karnofsky Performance Status; SCQ, Self-administered Comorbidity Questionnaire; SD, Standard deviation.
*Percentage totals exceed 100% because patients may have more than one type of cancer or treatment.
CUTPOINTS FOR LOW AND HIGH NUMBERS OF SYMPTOMS1029
subscales and two component scores that evaluate important
health concepts. Higher scores indicate better QOL.32,33
Data were analyzed using SPSS 18.0 (SPSS Inc., Chicago,
IL).Descriptive statistics were usedtocharacterize thesample
and the study variables. Symptom occurrence rates were
generated for each of the symptoms evaluated on the MSAS.
Total number of symptoms was calculated by summing
the number of symptoms based on a response on any one of
the four dimensions—occurrence, frequency, severity, and
A cutpoint that divided the sample into low and high
number of symptoms was created using the analytic strategy
of Serlin and colleagues.1Twelve categorical variables that
represented dichotomizing the number of symptoms into low
and high using the twelve possible cutpoints between 5 and
16 were created (e.g., 0–5=low, 6–32=high, 0–6=low, 7–
32=high, and so on up to 0–16=low, 17–32=high) and re-
lated to the five MQOLS-CA2 subscales using multivariate
analysis of variance (MANOVA) and to the MQOLS-CA2
total score using analysis of variance (ANOVA). Combina-
tions of cutpoints were tested to yield two cutpoints (three
groups) as well as one cutpoint (two groups) solutions. The
criterion used to determine the optimal cutpoint groups
was the F-ratio for the between-group effect for both the
MANOVA and the ANOVA (Table 1). While attempts were
made to establish cutpoints for low, medium, and high total
number of symptoms, a clear cutpoint between medium and
high was not identified. Therefore, the analysis proceeded to
determine a single cutpoint solution. Five symptoms was
of testable cutpoints, because no patient reported fewer than
5 symptoms, and 16 symptoms was approximately equal to
the mean number of symptoms for the sample.
To determine if the optimal cutpoint for the total number of
symptoms differed between the low and high symptom
groups on demographic and clinical characteristics, inde-
used. Preliminary analyses revealed significant between-
groups differences for age and living arrangements. Because
only age is associated with depression,34,35anxiety36and/or
QOL37,38analyses of covariance (ANCOVA), controlling for
age, were used to evaluate for between-group differences in
these measures. All calculations used actual values. Adjust-
ments were not made for missing data. Therefore, the cohort
for each analysis was dependent on thelargest set of complete
data between the groups. A p-value of<0.05 was considered
Table 3. Differences in the Rank Order of Symptom Occurrence Rates in the Low and High Symptom Groups
Low symptom group (n=43) High symptom group (n=67)
rate % Symptom
Lack of energy
Numbness/tingling in hands/feet
Lack of appetite
Change in the way food tastes
Problems with sexual interest or activity
Problems with urination
Shortness of breath
Swelling of arms or legs
‘‘I don’t look like myself’’
Changes in skin
Lack of energy
Lack of appetite
Problems with sexual interest or activity
Numbness/tingling in hands/feet
‘‘I don’t look like myself’’
Changes in skin
Change in the way food tastes
Shortness of breath
Swelling of arms or legs
Problems with urination
1030 GILBERTSON-WHITE ET AL.
As shown in Table 1, a cutpoint of £12 symptoms (i.e.,
0–12 symptoms is low and 13–32 symptoms is high) was
the optimal cutpoint, in that it had the largest between-
group F-ratios for both the MQOLS-CA2 subscale and total
scores. Using £12 symptoms as the cutpoint, 60.9% of the
sample (n=67) was classified as having a high number of
Differences in demographic
and clinical characteristics
Consistent with the American Cancer Society’s definition
of advanced cancer,39the majority of the patients had met-
astatic disease (*90%) and their goals of treatment were
control or palliation (*96%). Except for age and living ar-
rangements, no differences were found between the low
and high symptom groups in any demographic or clini-
cal characteristics (Table 2). Patients in the high symptom
the low (n=43) and high (n=67) symptom groups.
Differences in Center for Epidemiologic Studies–Depression (CES-D) subscale and total scores between patients in
high (n=67) symptom groups. All values are plotted as means–standard error of the means after controlling for age (p
values, *<.05, **£.001,
Differences in Spielberger State–Trait Anxiety Inventories (STAI) scores between patients in the low (n=43) and
CUTPOINTS FOR LOW AND HIGH NUMBERS OF SYMPTOMS1031
group were significantly younger and were less likely to live
Differences in symptom occurrence rates
As shown in Table 3, differences were found in the occur-
rence rates and rank order of the various MSAS symptoms.
Pain, lack of energy, feeling drowsy, difficulty sleeping, con-
stipation, lack of appetite, worrying, feeling sad, and diffi-
culty concentrating ranked within the top 12 for both the low
and high symptom groups. Numbness/tingling in hands/
feet, changes in the way food tastes, and dry mouth were
among the top 12 symptoms for the low but not for the high
symptom group. In contrast, feeling nervous, feeling irritable,
and nausea were in the top 12 for the high but not for the low
symptom group. Of note, all four of the psychological
symptoms (i.e., feeling sad, worrying, feeling nervous, feeling
irritable) were among the top 12 symptoms in the high
With regard to occurrence rates, pain and lack of energy
had similar occurrence rates in both symptom groups. For the
low symptom group, occurrence rates for the next ten
symptoms ranged from as high as 73.2% for feeling drowsy
10 highest ranked symptoms had much higher occurrence
rates (i.e., 90.9% for feeling sad to 66.7% for nausea).
(QOL) scores between patients in the low (n=43) and high (n=67) symptom groups.
Differences in Multidimensional Quality of Life Scale–Cancer 2 (MQOLS-CA2) subscale and total quality of life
limitations–physical, BP=bodily pain, GH=general health, V=vitality, SF=social functioning, RE=role limitations–emo-
tional, MH=mental health) and component (PCS=physical component score, MCS=mental component score) scores be-
tween patients in the low (n=43) and high (n=67) symptom groups. All values are plotted as means–standard error of the
means after controlling for age (p values, *<.05, .**£.01,+<.0001).
Differences in Medical Outcomes Study–Short Form 36 (MOS-SF36) subscale (PF=physical functioning, RP=role
1032GILBERTSON-WHITE ET AL.
Differences in depression and anxiety scores
After controlling for age, significant between-group dif-
ferences were found in two of the four CES-D subscales (so-
matic and depressed affect) as well as in the total CES-D score
(Figure 1A). Patients in the high symptom group reported a
higher somatic and depressed affect subscale scores as well as
total CES-D score.
After controlling for age, significant between-group dif-
ferences were found in both anxiety scores (Figure 1B). Pa-
tients in the high symptom group reported significantly
higher state and trait anxiety scores.
Differences in QOL scores
As expected, after controlling for age, significant between-
group differences were found in the total MQOLS-CA2
score as well as in four of the five MQOLS-CA2 subscale
(physical, nutrition, symptom distress, and psychological)
scores (Figure 2A). Patients in the high symptom group had
lower subscale and total MQOLS-CA2 scores.
After controlling for age, significant between-group dif-
ferences were found for seven of eight MOS-SF36 subscale
scores (physical functioning, bodily pain, general health, vi-
tality, social functioning, role limitations–emotional, and
mental health), as well as in the mental component score
(Figure 2B). Patients in the high symptom group reported
significantly lower MOS-SF36 scores.
This study is the first to determine the optimal cutpoint for
total number of symptoms in patients with advanced cancer.
This finding suggests that the concept of a clinically mean-
ingful cutpoint for symptom severity scores is transferable to
total number of symptoms. In this sample, the cutpoint of 12
symptoms successfully differentiated between patients with
advanced cancer based on a significant jump in both MQOL-
CA2 subscale and total scores.
Validation of 12 symptoms as the optimal cutpoint was
supported by significant between-group differences in de-
pression and anxiety scores and in a generic measure of QOL.
Asshown in Table 4, between-groupdifferences in thesescores
equate with medium to large effect sizes.40Previous research
suggests that an effect size of 0.2 to 0.5 is considered a mini-
mally important difference and a clinically meaningful differ-
ence in QOL measures.41–43Cinical significance goes beyond
statistical significance to identify whether a change is large
enough to be noticed by the patient.44–47Our findings suggest
that when a patient crosses the threshold from 12 to 13 symp-
MQOLS-CA2 total scores in this study were similar to those
reported in previous studies of oncology patients.48,49Overall,
patients with advanced cancer appear to have moderate dec-
rements in QOL. However, further research is needed to de-
termine the generalizability of these findings and whether
The cutpoint that differentiated between low and high
number of symptoms was validated by between-group dif-
ferences in the rank order of the psychological symptoms on
the MSAS. All four psychological symptoms (worrying, feel-
ing sad, feeling nervous, feeling irritable) were among the top
12 symptoms in the high symptom group. In contrast, in the
low symptom group, each psychological symptom had a
lower overall rank and occurrence rate, and only worrying
and feeling sad were in the top 12 symptoms.
CES-D scores for the low and high symptom groups in this
study were similar to scores reported by patients with ad-
vanced head and neck cancer.52,53In contrast, higher total
CES-D scores were reported by patients with advanced stages
may be attributed to heterogeneity in cancer diagnoses,
treatment regimens, and timing of assessments.
Mean state and trait anxiety scores in this study are similar
to previous reports of patients with advanced cancer.56–58
State anxiety increases in response to physical danger and
The consistent levels of anxiety across studies suggest that
patients with advanced cancer may experience acute anxiety
from a variety of physical and emotional stressors as well as
chronic anxiety associated with depressive symptoms.
In this study, mean MOS-SF36 subscale and component
scores for the total sample ranged from 32.1 (–8.8) for the
physical component score to 64.8 (–19.8) for the mental
health subscale. These scores are similar to those reported in
one study,60lower than scores reported in three studies of
patients with advanced cancer,61–63and higher than scores
reported in another study64of patients with advanced cancer.
Reasons for these inconsistencies may include differences in
studies’ definition of advanced cancer, their inclusion and
exclusion criteria, and timing of the assessments.
Differences in patients’ reports of symptom occurrence and
the rank order of the most common symptoms support the
between-group differences found for the depression, anxiety,
and psychological/mental health domains of the MOS-SF36.
The largest effect sizes were found for the mental component
and subscale scores related to psychological status (social
functioning, vitality, role limitations–emotional, mental health).
Table 4. Effects Sizes for Between-Group Differences
(High-Low) in Subscale and Total Scores
for the Validation Scales for Depression,
Anxiety, and Quality of Life
Center for Epidemiologic Study–Depression (CES-D) Scale
Total CES-D score
Spielberger State–Trait Anxiety Inventories
Trait anxiety score
State anxiety score
Medical Outcomes Study–Short Form 36
Role limitations, physical
Role limitations, emotional
Physical component score
Mental component score
CUTPOINTS FOR LOW AND HIGH NUMBERS OF SYMPTOMS1033
Emerging evidence suggests that psychological symptoms
contribute to decrements in QOL in patients with advanced
cancer.65–68For example, higher depression scores were as-
sociated with higher symptom severity scores.69In addition,
in a study of cancer patients in their last year of life,68higher
levels of depressive symptoms at enrollment were associated
with a worse symptom experience over time. It is not clear if
psychologicalsymptomsresult in more symptoms orif length
of time since diagnosis produces psychological ‘‘wear and
tear’’ that results in more psychological and physical symp-
toms. Furthermore, it is not known if psychological and ex-
istential distress increase in patients with advanced cancer as
they approach the end of life.70
Several study limitations need to be acknowledged. In this
relatively small sample, only one optimal cutpoint for total
number of symptoms was found. However, studies with
larger samples may identify additional cutpoints. The fairly
homogeneous sample of white and well-educated adults, all
of whom had pain, limits the generalizability of the findings.
However, given that pain was a highly prevalent symptom in
both symptom groups, it is unlikely that the results of this
study could be attributed only to pain. Finally, it is not pos-
sible to separate the effects of cancer and its treatment (e.g.,
side effects of medications) and the effects of chronic medical
conditions on the patients’ symptom experience.
Study findings suggest that a threshold exists between low
and high number of symptoms in patients with advanced
cancer. Additional research is needed to confirm these results
and determine if additional cutpoints can be identified. In
addition, studies need to determine if the use of cutpoints for
total number of symptoms leads to improvements in clinical
assessments and more tailored interventions for this vulner-
able population. With the movement in health care toward
systematizing best practices in an efficient manner, a need
exists to develop screening criteria which, even if automated,
would assure that the maximum number of patients who are
at greatest risk for worse symptom outcomes are recognized
with the minimum amount of effort. In the meantime, clini-
cians can administer a symptom checklist like the MSAS on a
routine basis. Patients who report the occurrence of ‡13
symptoms warrant more detailed evaluation and more ag-
gressive symptom management.
This work was supported by a grant (CA 116423) from the
National Cancer Institute and the National Institute of Nur-
sing Research. Dr. Miaskowski receives support from the
American Cancer Society as a Clinical Research Professor. Dr.
Aouizerat was funded through National Institutes of Health
Roadmap for Medical Research Grant KL2 RR624130. The
authors gratefully acknowledge the patients and family
caregivers who participated in this research and our many
colleagues who assisted with participant recruitment.
Author Disclosure Statement
No conflicting financial interests exist.
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Address correspondence to:
Christine Miaskowski, R.N., Ph.D., FAAN
Department of Physiological Nursing
University of California
2 Koret Way, Box 0610
San Francisco, CA 94143-0610
1036 GILBERTSON-WHITE ET AL.