A B S T R A C T S
Androgen deprivation therapy (ADT) is
commonly used to treat prostate cancer (PC). However, ADT is
associated with significant side effects including declines in
quality of life (QOL), physical function, and muscle strength.
Existing evidence from multiple clinical trials demonstrates
that exercise in this population is associated with
improvements in many of these side effects. However, these
benefits are most consistently observed with a supervised
1:1 in-centre exercise program which is not economically
sustainable in a public health care setting. Alternative
approaches such as supervised group and home-based
programs are promising but need to be tested rigorously
against 1:1 supervised exercise.
Our primary objective in this phase II trial
was to determine whether group-supervised or home-based
supported programs are non-inferior to a supervised 1:1
exercise program in terms of benefits in QOL and physical
fitness in men with PC on ADT. Secondary objectives include
examination of long-term adherence and cost-effectiveness.
Feasibility endpoints included recruitment, retention, and
adherence rate, satisfaction, and outcome capture.
Men diagnosed with histologically confirmed
PC, starting or continuing on ADT for at least 6 months or
who remained biochemically castrate after stopping ADT
were randomized (1 personal training:1 group-supervised:1
home-based). Randomization was stratified by length of ADT
use (<3 months versus
3 months). QOL, fatigue, and fitness
measures were completed every 3 months for 12 months (6
month intervention phase and 6 month follow-up phase).
Participants completed 4-5 days per week of moderate-
intensity, mixed modality exercise incorporating aerobic,
resistance, and flexibility training. Primary outcomes were
analyzed using linear mixed effects model with subject-
specific random effects and group-by-time interactions.
59 participants (mean age 69.9 years) were
enrolled. The recruitment rate was 28.7% and the retention
rate was 71.2%. The only significant between-group difference
was observed comparing the home-based approach to
the 1:1 arm, with slightly worse Functional Assessment of
Cancer Therapy (FACT) Prostate scores in the home-based
arm (delta 4.79 points, p=0.0103). All other measures of QOL
including the FACT-General and FACT-Fatigue questionnaires
were similar between groups. Grip strength was also slightly
worse in the home-based arm compared to the 1:1 arm (delta
-3.90 kg, p=0.0044). Other fitness measures, including VO2
max, grip strength, and chair stands, were similar between
groups. There were no grade 3 or higher adverse effects. Other
feasibility endpoints were acceptable.
A group-supervised exercise program in men
with PC on ADT appeared to be non-inferior when compared
to the gold standard 1:1 supervised exercise program for both
QOL and fitness outcomes. A home-based approach also
appeared to be non-inferior for most outcomes. These results
suggest that a less resource-intensive exercise program may
provide similar QOL and fitness benefits and that further
investigation of the efficacy and cost-effectiveness of less
resource-intensive programs in a phase 3 RCT is warranted.
Results and lessons learned from this trial will help to inform
a phase 3 trial.
Disclosure of interest:
Androgen deprivation therapy, exercise/physical
fitness, fatigue, prostate cancer, quality of life
PREVALENCE AND FACTORS ASSOCIATED WITH HIGH
LEVEL OF DISTRESS AMONG OLDER CANCER PATIENTS
*, L. Elmquist
, B. Korc-Grodzicki
Cancer & Aging Research Program
Medicine/Geriatrics and Oncology,
Geriatrics, Memorial Sloan Kettering Cancer Center, NYC, United
Older cancer patients are at increased risk of
suffering high levels of distress (HLD).
Our study aims to assess the prevalence
of HLD among these patients and its association with
sociodemographic and geriatric assessment (GA) factors.
Older cancer patients were screened for HLD
using the Distress Thermometer (DT) as a part of geriatric
preoperative evaluation in 2015 DT score ranges from 0 to
10, and those with score
4 were considered to have HLD.
Sociodemographic (age, gender, marital status, education,
and living condition) and GA variables: activities of daily
living (ADL), instrumental Activities of Daily Living (ADL),
patient-rated Karnofsky Performance Scale (KPS) score,
history of falls in the past year, timed up and go (TUG)
test, social support (Medial Outcome Study-Social Support
Survey), social activity limitation (Medical Outcome Study),
weight loss in the past year, depression (geriatric depression
scale(GDS)-4item), and vision and hearing quality were
captured. Bivariate analysis for the association between each
factor and HLD was performed. Variables with statistically
significant (p<0.05) correlation with HLD were entered into a
multivariate analysis model.
In total 584 patients completed DT (median age
80) and 53.1% had HLD. In bivariate analysis, being female
(p<0.001), marital status other than married (p=0.02), and
living alone (p=0.006) were associated with HLD. Among GA
variables, lower KPS (p<0.001), lower score in ADL (p<0.001),
and iADL (p<0.001), more limitation in social activities
(p<0.001), higher depression score (p<0.001), poor vision
10 seconds (p<0.001) were associated with
HLD. Multivariate analysis showed that being female (OR-
2.66, p<0.001), living alone (OR=2.17, p<0.013), more limited
in social activities (OR=1.23, p<0.001), and higher depression
score (OR=1.44, p<0.001) were associated with HLD.
More than half of older cancer patients
undergoing surgery experience HLD. Addressing modifiable
factors associated with HLD by involving the appropriate
health professional and treating depression may improve
patients’ distress level.
Disclosure of interest:
Distress and psycho-social issues, Geriatric
assessment, Preoperative assessment, Surgery