Annual Meeting Proceedings Part 1 - American Society of Clinical ...

9106 General Poster Session (Board #46D), Sat, 8:00 AM-12:00 PM
Understanding the symptom experience of breast cancer outpatients: The
validity and utility of the M.D. Anderson Symptom Inventory (MDASI).
Presenting Author: Tito R. Mendoza, University of Texas M. D. Anderson
Cancer Center, Houston, TX
Background: Breast cancer and its treatments can produce multiple
symptoms that cause distress and impair function. The MDASI, a patientreported
outcome measure of symptoms (sxs) and functional interference
has been validated in general oncology and has the potential to inform
symptom experience and guide treatment specific to breast cancer patients
(pts). Methods: The Eastern Cooperative Oncology Group (ECOG) conducted
the Symptom Outcomes and Practice Patterns (SOAPP) study at academic
and community medical oncology clinics and included pts with breast
cancer of all stages and phases of care. At baseline and 4 weeks, pts
completed the MDASI. Symptom experiences and psychometric properties
of the MDASI in breast cancer pts (n � 1544) were analyzed. Results: The
median age was 58 years, and the race/ethnicity included 11% black and
8% hispanic. 5% had ECOG performance status (PS) �2. The 5 most
prevalent moderate/severe sxs reported at baseline were fatigue (31%),
disturbed sleep (27%), drowsiness (21%), hair loss (22%) and dry mouth
(19%); moderate/severe skin rash (6%) and vomiting (4%) were the least
prevalent. At follow-up, about 1/3 of patients had moderate/severe fatigue
and 19% had moderate/severe pain and distress. Internal consistency and
test-retest reliability were good, with Cronbach alphas of �0.85 and
intraclass correlations of �0.76 for all subscales. Among those whose PS
was stable or improving, the change scores in sx severity improved most for
sleep disturbance, numbness/tingling, and difficulty remembering things.
Significantly higher scores and moderately large effects for the severity
scale were reported by pts with poorer PS (ES�.61) and those with
local/regional/metastatic disease (ES�.67). Results were similar for the
interference scale. Pts whose quality of life (QOL) declined showed greater
increase in severity (1.1 vs .07, p�.001) from baseline to follow-up than
pts whose QOL was unchanged, demonstrating sensitivity to change.
Conclusions: Breast cancer pts have significant sx burden despite wellpreserved
PS. The MDASI is a valid, reliable, and sensitive sx assessment
method for research and patient care in breast cancer outpatients.
9108 General Poster Session (Board #46F), Sat, 8:00 AM-12:00 PM
Comparing three validated methods of patient self-reported fatigue in a
prospective randomized clinical trial. Presenting Author: Katherine Sams,
Wake Forest University, Winston Salem, NC
Background: Fatigue can be measured with different validated assessment
instruments in symptom management trials. Methods: Between 2004-
2009, the Wake Forest CCOP Research Base protocol 97202 randomized
236 women receiving adjuvant chemotherapy for newly diagnosed breast
cancer to Coenzyme Q10 supplementation vs placebo. The primary
endpoint was change in self-reported fatigue. Patients (pt) were assessed at
baseline, 8, 16, and 24 weeks (wk) with 3 instruments: 1) Profile of Mood
States – Fatigue (POMS; 7 questions; scored 0-4); 2) Functional Assessment
of Cancer Treatment – Fatigue (FACIT; 13 questions; scored 0-4);
and 3) Visual Analog Scale (VAS; one scale; scored 0-10). For comparison,
each instrument was rescaled from 0 to 100; higher numbers indicate
worse fatigue. Results: CoQ10 did not significantly affect fatigue (Lesser G
et al, ASCO Proc., 2010). All 3 measures demonstrated an increase in
fatigue after chemotherapy initiation at 8&16wkswith trend towards
baseline levels at 24 wks. The fatigue measures were highly correlated: r �
0.8 for all pairwise associations at all times. However, their scores varied.
The Table shows mean rescaled scores for pt below/above the median
fatigue level, calculated by taking mean of the three scores averaged across
the four time periods. In general, POMS tended to give the lowest and VAS
the highest scores, but differences between POMS and FACIT and FACIT
and VAS depended on mean fatigue level. For pt experiencing lower
(�median) fatigue, FACIT and VAS scores were similar, while POMS scores
were significantly lower. For higher (�median) fatigue, POMS and FACIT
scores were similar, while VAS was significantly higher. Conclusions: While
POMS, FACIT, and VAS scores were highly correlated, their scale scores
varied depending on the level of fatigue experienced by the pt. Fatigue
assessment methods in clinical trials should be selected carefully as they
do not always give equivalent results. Supported by NCI/DCP grant U10
CA81851.
Means (standard deviations) by average level of fatigue across all time
points.
Instrument < Median fatigue (N�116) > Median fatigue (N�116)
POMS 10.8 (7.6) 41.6 (17.9)
FACIT 14.1 (9.0) 41.4 (14.3)
VAS-F 15.3 (9.8) 48.2 (14.9)
Patient and Survivor Care
593s
9107 General Poster Session (Board #46E), Sat, 8:00 AM-12:00 PM
A randomized trial evaluating the integration of online questionnaires into
follow-up (FU) care for early-stage breast cancer (ESBC). Presenting
Author: Alyse Wheelock, University of California, San Francisco Helen
Diller Family Comprehensive Cancer Center, San Francisco, CA
Background: Large numbers of cancer survivors have led to the need for FU
care addressing lasting effects of BC and its treatment. We conducted a
trial evaluating formats of FU care to determine if integration of remote
electronic questionnaire FU provides for timely symptom management and
more efficient care than routine clinic visits alone. Methods: Patients (pts)
with ESBC were randomized to either usual care (UC, frequency of visits
determined by oncology providers) with completion of an optional online
health and symptom questionnaire (Q) before each clinic visit, or to
SIS.NET FU care, in which pts were scheduled for up to 3 routine oncology
related clinic visits over 18 mos and completed the online Q every 3 mos.
Qs were reviewed by a survivorship nurse practitioner (NP) with pt phone
contact for symptoms requiring urgent attention. We recorded the time
between electronic symptom reporting and FU for pts in the SIS.NET arm.
Data included the number of oncology related clinic visits, total number of
physician visits, and number of medical tests including labs and imaging
studies ordered. Kolmogorov-Smirnov tests for equal distributions were
used to determine if there were any significant differences between
SIS.NET and UC. Results: 100 pts were enrolled, 75 completed the 18
month study and 25 pts remain in FU. For the 75 pts, 85% received
chemotherapy and 77% received hormone therapy. Pts in the SIS.NET arm
completed an average of 3.8 out of 7.2 emailed surveys (52.6%), and pts in
the UC arm completed an average of 2.2 out of 3.4 (69.1%) routine
pre-clinic surveys. For pts in the SIS.NET arm, 75% of reported symptoms
were reviewed by a NP in � 3 days. There was no significant difference
between SIS.NET and UC FU for oncology related clinic appointments,
total number of physician visits, or number of medical tests performed.
Conclusions: Use of on-line health and symptom surveys with remote NP
review provided timely symptom FU but did not reduce clinic visits or
medical testing in pts with ESBC. Further analyses of these data as well as
additional studies are necessary to understand the barriers to integration of
web-based tools to achieve more efficient FU care for BC survivors.
9109 General Poster Session (Board #46G), Sat, 8:00 AM-12:00 PM
Anemia and functional disability in older adults with cancer. Presenting
Author: Cynthia Owusu, Case Western Reserve University, Cleveland, OH
Background: While anemia is associated with functional disability in older
adults in general, this relationship has not been well characterized in older
adults with cancer. We sought to examine the association between anemia
and functional disability and to identify other factors associated with
functional disability in patients (pts) age �65 with cancer. Methods: We
conducted a secondary analysis of a multi-center prospective study of 500
pts � age 65 that identified predictors of chemotherapy (chemo) toxicity
(Hurria et al, JCO, 2011). The primary outcome of this analysis was
functional disability, defined as need for assistance with �1 instrumental
activities of daily living. Data collected prior to initiation of a new chemo
regimen included: age, tumor/treatment variables, labs [including hemoglobin
(Hb)], and geriatric assessment (functional status, comorbidity, social
support, psychological, cognitive, and nutritional status). Anemia (World
Health Organization criteria) was defined as Hb �12g/dl (women) and Hb
�13g/dl (men). Bivariate analysis and logistic regression were used to
examine the association between functional disability, anemia, and other
pre-treatment variables. Results: Among 500 pts [median age 72 years
(range 65-91), 56% female, 61% stage IV], the prevalence of functional
disability and anemia was 43% and 51%, respectively. The mean Hb was
11.7g/dl and 12.6g/dl among pts with and without functional disability.
Pts with anemia were more likely to report functional disability (53% vs.
46%, p�0.01). On multivariate analysis, factors associated with functional
disability included anemia [Odds Ratio (OR)� 2.06, 95% confidence
interval (CI)� 1.39-3.05], increased age (OR� 1.04, 95% CI �
1.00-1.07), increased comorbidity (OR� 1.23, 95% CI � 1.09-1.39),
advanced stage (OR� 1.85, 95% CI � 1.22-2.80), and unintentional
weight loss (OR� 2.02, 95% CI � 1.37-3.00). Conclusions: Anemia was
highly prevalent and was associated with functional disability. Prospective
studies that further examine the relationship between anemia and functional
disability and randomized-controlled trials that evaluate the correction
of anemia as a modifiable strategy to improve functional status in older
pts with cancer are warranted.
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