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

592s Patient and Survivor Care
9102 General Poster Session (Board #45H), Sat, 8:00 AM-12:00 PM
Clinical trial participation as part of end-of-life (EOL) cancer care:
Associations with medical care near death and bereaved caregivers’ mental
health. Presenting Author: Andrea Catherine Phelps, Dana-Farber Cancer
Institute, Boston, MA
Background: Clinical trial participation is necessary to improve existing
therapies, encouraged by national guidelines, and common among advanced
cancer patients. The relationships between trial participation and
important EOL outcomes such as aggressive care are unknown. Methods:
Coping with Cancer Study, an NCI-funded multicenter prospective cohort
study of advanced cancer patients and their caregivers, enrolled September
2002 – February 2008. Patients were interviewed at baseline, and clinical
trial participation was documented by chart review. Patients were followed
to death, (median 4.4 months from baseline). Medical care and quality of
life (QOL) in the last week of life was assessed by caregiver interview and
chart review. Caregiver interview 6 months post-bereavement assessed
QOL and mental health (Structured Clinical Interview for the DSM-IV). The
primary outcome was aggressive EOL care (ventilation, resuscitation, or
chemotherapy in the last week of life). Secondary outcomes were bereaved
caregivers’ mental health and QOL. Propensity-score weighting balanced
patient characteristics (e.g. clinical variables, EOL preferences) that
differed by trial participation. Propensity-score weighted regression models
estimated the effect of trial participation on outcomes. Results: Of 246
patients followed to death with non-missing propensity scores, 27 were
clinical trial participants. In propensity-score weighted analyses, trial
participation was significantly associated with aggressive EOL care [29.6%
v 9.1%; adjusted OR (AOR), 12.14; 95% CI, 3.65-40.36], ICU admission,
mechanical ventilation, chemotherapy, and a trend toward inferior QOL
near death (p � 0.069). Of 180 matched caregivers, trial participation
predicted less mental illness [AOR, 0.15; 95% CI 0.04-0.57], major
depression [AOR, 0.25; 95% CI, 0.08-0.80], but was unassociated with
QOL (p � 0.15) in adjusted analyses. Conclusions: Clinical trial participation
is associated with increased risk of aggressive EOL care for advanced
cancer patients, but better mental health for bereaved caregivers.
9104 General Poster Session (Board #46B), Sat, 8:00 AM-12:00 PM
Comparative patient-centered outcomes (health state and adverse sexual
symptoms) between adjuvant brachytherapy versus no adjuvant brachytherapy
in early-stage endometrial cancer. Presenting Author: Shari Damast,
Yale University School of Medicine, New Haven, CT
Background: We performed a cross-sectional analysis of survivors of stage I
endometrial cancer (EC) to examine the relationship between receipt of
adjuvant intra-vaginal radiation therapy (IVRT), health state (HS), and
sexual functioning (SF). Methods: Survivors were administered anonymous
questionnaires containing demographic and treatment-related items, the
EQ5D to measure current HS, and the Female Sexual Function Index (FSFI)
to measure current SF. All were disease-free and had undergone simple
hysterectomy (SH) with or without adjuvant IVRT at least one year prior to
questionnaire completion. None had received chemotherapy or hormonal
therapy. The study was IRB-approved under a waiver of consent. The
primary endpoint was a comparison of EQ5D-health states and FSFI scores
between survivors who had received SH alone and those who had received
SH and adjuvant IVRT. Fisher’s exact test was used to compare IVRT and
no-IVRT groups and multivariate regression was applied to find associations
between factors and the outcome measures. Results: 136 (66.3%) participants
had undergone SH alone and 69 (33.7%) had undergone SH and
adjuvant IVRT. The SH alone group was younger; otherwise, the two groups
were balanced with respect to ethnicity, marital status, education level,
medical co-morbidities (diabetes, hypertension, anxiety), type of SH
(laparotomy vs minimally invasive surgery-MIS), and baseline sexual
activity. In the IVRT and no-IVRT groups, the median EQ5D-health states
were 88 (range 40-100) and 85 (range 10-100) respectively, and the
median FSFI scores were 14.1 (range 1.2-35.4) and 16.5 (range 1.2-34.8)
respectively. Controlling for age and type of SH, receipt of IVRT was
associated with better HS (p�0.018) and not associated with poorer SF
(p�0.1399). Receipt of laparotomy (vs MIS) was associated with poorer
HS and worse SF (p�0.0156 and p�0.0115, respectively), and its
detrimental effect on FSFI score was more pronounced in the IVRT
compared to no-IVRT group (p�0.0486). Conclusions: Compared to SH
alone, receipt of adjuvant IVRT was generally not associated with poorer SF
or HS.
9103 General Poster Session (Board #46A), Sat, 8:00 AM-12:00 PM
Changes in patient-reported outcomes in women with breast cancer in a
multicenter double-blind randomized controlled trial assessing the effect
of acupuncture in reducing aromatase inhibitor-induced musculoskeletal
symptoms (AIMSS). Presenting Author: Ting Bao, University of Maryland
Greenebaum Cancer Center, Baltimore, MD
Background: Aromatase Inhibitors (AIs) have been associated with worsening
of patient related outcomes (PROs) such as AIMSS, menopausal
symptoms and depression. Acupuncture has been reported to alleviate
such symptoms. We hypothesized that real acupuncture (RA) would
improve PROs more than sham acupuncture (SA). Methods: We collected
PROs at baseline, 4, 8, and 12 weeks (wks), from women enrolled in a
multi-center double blind RCT designed to assess the effect of acupuncture
in reducing PROs. Patients were randomized to 8 wkly RA or SA. PROs were
measured by the revised National Surgical Adjuvant Breast and Bowel
Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological
Studies Depression Scale (CESD), Hospital Anxiety and Depression
Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily
Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQoL
survey. We measured estrogen and cytokines concentrations at baseline
and wk 8. We used Wilcoxon rank sum and signed-rank tests to make
comparisons between and within group, respectively. Results: We included
23 patients from RA and 24 from SA arms in the intent-to-treat analysis.
We have previously reported no significant difference in reduction of AIMSS
between two arms. RA caused reduction of CESD scores compared to SA
(median: -2 vs 0, p � 0.057). When compared to baseline, there were
statistically significant improvements at wk 8 in hot flash severity score
(p�0.006), hot flash frequency (p�0.011), HFRDI (p�0.014) and NSABP
menopausal symptoms (p�0.022) scores in RA arm; for EuroQoL
(p�0.022), HFRDI (p�0.043) and NSABP menopausal symptoms
(p�0.005) scores in SA arm. The majority of patients’ estradiol concentrations
were undetectable at baseline and wk 8. Changes in other time points,
data and analysis of cytokines changes will be presented at the meeting.
Conclusions: Real and sham acupuncture were both associated with
improvement in PROs in breast cancer patients taking AIs. We detected no
significant difference in the change of PROs between real and sham
acupuncture, except for CESD.
9105 General Poster Session (Board #46C), Sat, 8:00 AM-12:00 PM
A randomized trial of a cardiopulmonary resuscitation (CPR) video (V) in
advance care planning (ACP) for progressive hepatopancreaticobiliary
cancer patients. Presenting Author: Andrew S. Epstein, Mount Sinai, New
York, NY
Background: CPR is an important advance directive topic in patients with
progressive cancer; however such discussions are challenging. Previous
work by Volandes et al suggests that V images help, however whether V
educational information about CPR engenders broader ACP discourse is
unknown. Methods: A randomized trial of an educational V or narrative (N)
in patients with progressive hepatopancreaticobiliary cancers was conducted.
The V and N were 3 minutes long and contained an identical
description of CPR. Primary endpoint: ACP documentation 1-month
post-test (either a formal advance directive or a documented ACP discussion),
80% powered with 0.01 type-I error rate for estimated advance
directive completion rates of 70% V arm vs. 25% N arm with a sample of
56 subjects. Secondary endpoints (exploratory): impressions of the study
information; pre and post knowledge of and preferences for CPR and
mechanical ventilation; and follow-up longitudinally (to death or 6 months
post-test). Results: 56 subjects consented and analyzed. 1-month post-test
ACP documentation was not significantly higher in the V arm (12/30,
40.0%) vs. the N arm (4/26, 15.4%); Fisher’s exact test, OR � 3.583
[95% CI: 0.886 – 17.937], p � 0.07. Knowledge increased in both arms
after the intervention. Preferences for CPR changed in V arm but not in N
arm; for mechanical ventilation, there was no change in either arm. The
majority of subjects in both arms reported the information as helpful,
comfortable to discuss, and recommended to others. Longitudinally,
outcomes were similar between V & N arms, respectively: % advance
directives completed (63% & 58%); median days from test to advance
directive (60 & 72) and advance directive to death (21 & 20); median ACP
documentation after 1 month (0 & 1); median hospital admissions (1 & 1),
days of stay (5 & 7), ICU stays (0 & 3) and CPR/mechanical ventilation (1 &
3). 52% of all subjects died by study end, the majority in hospice care.
Conclusions: This first randomized trial addressing downstream ACP effects
of V vs. N decision tools demonstrated a trend towards more ACP
documentation in V patients. Further research into these types of educational
media is needed.
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