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

602s Patient and Survivor Care
9142 General Poster Session (Board #50H), Sat, 8:00 AM-12:00 PM
YOCAS yoga, fatigue, memory difficulty, and quality of life: Results from a
URCC CCOP randomized, controlled clinical trial among 358 cancer
survivors. Presenting Author: Michelle Christine Janelsins, University of
Rochester Medical Center, Rochester, NY
Background: Memory difficulty is a serious problem for many cancer
survivors and can negatively affect quality of life (QOL). Little evidence
exists on the effects of physical activity (PA) interventions, such as yoga, on
memory in cancer survivors. We previously reported in a nationwide, Phase
III RCT that YOCAS Yoga, implemented over 4 weeks (2 x/wk; 75
min/session), significantly improved fatigue and QOL in cancer survivors.
The purpose of this study was to assess the effects of YOCAS on memory
and to identify moderating and possible mediating effects of memory in
YOCAS improvements of fatigue and QOL. Methods: Cancer survivors
between 2-24 months post adjuvant therapy with no participation in yoga
during the previous 3 months were randomized to standard care (SC) or SC
with YOCAS. YOCAS consists of breathing exercises, gentle Hatha and
Restorative yoga postures and meditation. This secondary analysis included
participants (N�358, mean age � 54, 96% female, 75% breast
cancer) who provided pre- and post-intervention data on Difficulty Remembering
Things (modified MD Anderson Symptom Inventory with 0 � “Did
not Interfere” to 10 � “Interfered Completely”), fatigue and QOL (FACIT-
F). ANCOVA was used to assess the effects of YOCAS on memory at
post-intervention incorporating baseline memory score. Path Modeling was
conducted to assess the moderating and mediating effects of memory on
YOCAS changes in fatigue and QOL. Results: ANCOVA revealed a significant
group effect of YOCAS on memory at post intervention (mean change: Yoga
- Control � -0.44; Cohen’s D� -0.24; p �0.05). Moderation analyses
revealed that baseline memory difficulty did not affect how much YOCAS
would improve fatigue (p�0.05) or QOL (p�0.05). Mediation analyses
identified changes in memory as a significant partial mediator for improved
fatigue (p�0.05) and improved QOL (p�0.05). Conclusions: YOCAS yoga
significantly reduces perceived memory difficulty in cancer survivors.
Improvements in memory due to YOCAS may be a possible mediator for
improving fatigue and QOL. More elaborate PA RCTs are needed to confirm
these results. Funding: NCIR25CA10618, K07CA120025, and
U10CA37420.
9144 General Poster Session (Board #51B), Sat, 8:00 AM-12:00 PM
Validation of the NCI patient-reported outcomes version of the common
terminology criteria for adverse events (PRO-CTCAE) in women receiving
treatment for metastatic breast cancer. Presenting Author: Sandra A.
Mitchell, National Cancer Institute, Bethesda, MD
Background: NCI PRO-CTCAE is designed to enhance adverse event
reporting by integrating patients’ self-report of the frequency (F), severity
(S) and interference (I) with usual activities of 78 symptomatic treatment
toxicities. This study examined the construct validity of a subset of
PRO-CTCAE items in women with metastatic breast cancer (MBC). Methods:
207 women (70% aged 45-59 years; 94% White;71% college-educated)
with HER2� MBC who had received treatment in the past month were
recruited from 6 U.S. breast cancer support groups and completed a web
survey that collected 18 PRO-CTCAE symptoms, and the Rotterdam
Symptom Checklist (RSC). Pairwise concordance among PRO-CTCAE
symptom dimensions was examined using weighted Kappa and Bowker’s
test for symmetry. Results: Respondents were a median of 47 months since
MBC diagnosis and 61% rated their health-related quality of life (HRQL) as
good to excellent. Symptom prevalence was similar for PRO-CTCAE and
RSC, with respondents more likely to endorse mood disturbance on
PRO-CTCAE (Anxiety/Worry 90%; Sad/Unhappy Feelings 86%) vs. RSC
(Anxiety 63%; Depressed Mood 61%). There was parallel rank-ordering of
fatigue, anxiety, insomnia, depression, difficulty concentrating and neuropathy
as the symptoms that were most severe, interfered most and caused
the greatest bother. Within PRO-CTCAE, pairwise agreement among F, S
and I was moderate for most symptoms (�w�.42 to .54). Agreement
between F and S was highest for pain, nausea and arm/leg swelling
(�w�.61 to .80), and lowest for anxiety/worry and sad/unhappy feelings
(�w� .27-.37). Except for arm/leg swelling, endorsement patterns by the
dimensions of F, S and I were distinct (Bowker’s p all �.002). Across
PRO-CTCAE symptoms, S was consistently higher than I (mean differences
.12 to .72, all p�.01]). Means for S were consistently and significantly
higher for those with impaired versus preserved HRQL, providing evidence
of construct validity. Conclusions: This study supports the construct validity
of PRO-CTCAE, and suggests that F, S and I dimensions offer nonoverlapping
information relative to 17 /18 PRO-CTCAE symptomatic
toxicities.
9143 General Poster Session (Board #51A), Sat, 8:00 AM-12:00 PM
Changes in the use of eythropoetin-stimulating agents (ESAs) in cancer
patients: Before and after FDA safety advisories. Presenting Author: Dana
Stafkey-Mailey, South Carolina College of Pharmacy, Columbia, SC
Background: Benefits of ESAs in the treatment of cancer-induced anemia
have been well documented, most importantly reducing the likelihood of
patients needing red blood cell transfusions. However, in early 2007, the
FDA issued a series of cautions and Black Box Warning (BBW), that ESAs
may enhance tumor progression, increase likelihood of a VTE and decrease
patient survival. The objective of this study is to elucidate population
patterns and trends in ESA use for cancer patients pre- and post- the BBW
and examine their associated outcomes. Methods: Data for this analysis was
derived from South Carolina Medicaid claims. Patients with a diagnosis of
Lung Cancer (162.x), Breast Cancer (174.x) or Non-Hodgkin’s Lymphoma
(200.x or 202.x) receiving chemotherapy between January 1, 1994 and
December 31, 2010 were eligible for inclusion. The main outcome
measures were ESA utilization, blood transfusion, and venous thromboembolism.
The percentage of patients experiencing these outcomes were
plotted over time to allow for visual examination of changes due to the
BBW. In addition, we used multivariable logistic regression models to
analyze each of the associated outcomes with clinical and demographic
variables. Results: Among the 9,280 patients with one of the study cancers,
an average of 25.4% received an ESA. The proportion of patients receiving
an ESA increased from 6.2% in 1994 to a high of 47.1% in 2005 at which
time utilization began to decline. In 2010, only 7.8% of these patients
received an ESA. Use was associated with older age, female sex, and
receipt of radiation therapy. The rate of blood transfusion varied sporadically
throughout the study period from 5.2% (2008) to 11.7% (1994)
(p�0.0001). Venous thromboembolisms developed in 12.3% and 8.5% of
patients receiving and not receiving an ESA, respectively (OR� 1.31;
p�0.001). Conclusions: As the FDA advisory cautioned, we find an
increased risk of venous thromboembolisms associated with ESA use. In
contrast to our a priori beliefs initial decline in utilization of ESAs began, in
2005, prior to the BBW and was likely due to changes in reimbursement
rates. However, the BBW resulted in the largest decline in ESA use, 19.1
percentage points, between 2007 and 2008.
9145 General Poster Session (Board #51C), Sat, 8:00 AM-12:00 PM
Health behaviors among testicular cancer survivors. Presenting Author:
Steven C. Palmer, University of Pennsylvania, Philadelphia, PA
Background: Testicular cancer survivors (TCS) experience elevated risk for
cardiovascular issues including coronary artery disease that present a
greater threat to their long-term health than recurrence of cancer. These
risks may be moderated by health behaviors (HBs), yet little is known about
HBs or their barriers in this population. This is unfortunate, as these
barriers may serve as intervention targets. This study examined HBs and
their barriers in a population-based sample of TCS. Methods: TCS were
recruited through the PA Cancer Registry. Eligible individuals were diagnosed
with testicular cancer between 1990 - 2007 and provided informed
consent. Participants completed measures of tobacco use, alcohol use,
dietary habits, physical activity, BMI, quality of life (QOL), and barriers to
performing HBs, as well as self-reported disease and treatment information.
Results: 189 participants provided data. Participants were middleaged
(M�44 yrs. R�19-59), predominately white (95%), married (72%),
parents (69%), 6.8 years post-diagnosis (R�1-19), and at normative levels
for physical and psychosocial QOL. A substantial minority (31%) was
unaware of their disease stage or histopathological type (27%), although
89% reported surgery, 32% chemotherapy, and 53% XRT. Almost 25%
reported current tobacco use, and 35% reported “risky” alcohol use.
Adequate aerobic activity was reported by half, but only 28% reported
adequate strength and flexibility activities. 84% reported above normal
BMI, with 35% in the obese range. Barriers to HBs included cancer-related
problems (e.g., neuropathy, pain, hernia risk) and competing demands
(e.g., work responsibility, time constraints). Cancer-related barriers were
related to worse physical QOL and higher BMI. Competing demands
predicted worse psychosocial QOL, unhealthy eating, and inadequate
physical activities. Conclusions: Given the negative HBs in this sample and
their potential cardiovascular risk, interventions aimed at reducing tobacco
and risky alcohol use, as well as improving dietary and physical activity
levels are needed. These interventions will likely need to overcome
perceived barriers to adoption of HBs in order to be successful.
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