Therapeutic Advances in Medical Oncology,
Journal Year:
2024,
Volume and Issue:
16
Published: Jan. 1, 2024
Patients
with
genitourinary
(GU)
malignancies
have
seen
the
development
of
multiple
life-prolonging
treatments
in
past
decade.
As
patients
and
clinicians
consider
their
treatment
options
along
cancer
journey,
time
spent
healthcare
contact,
or
"time
toxicity,"
has
emerged
as
a
new
outcome
measure
that
comprehensively
considers
receiving
care,
including
planned
visits
for
evaluation
well
unplanned
urgent
care
addressing
complications.
Despite
its
rising
study
across
populations,
there
been
surprising
lack
work
evaluating
toxicity
GU
cancers.
This
narrative
review
aims
to
summarize
available
studies
on
cancer,
deeper
dive
into
methodology,
strengths
limitations,
future
directions
field.
A
dedicated
section
focused
scenarios
best
practices
collect
data
can
serve
spark
interest
this
novel
health
survivors.
Ultimately,
is
relevant
patient-centered
metric
be
incorporated
clinical
trial
design
routine
influence
decision-making.
JCO Oncology Practice,
Journal Year:
2024,
Volume and Issue:
unknown
Published: Oct. 1, 2024
PURPOSE
Participating
in
phase
I
cancer
clinical
trials
often
entails
extra
visits
and
procedures.
We
describe
the
planned
time
procedures
associated
with
trial
participation.
METHODS
searched
ClinicalTrials.gov
for
of
new
drugs
assessment
schedules
results
posted
between
2020
2022.
Trials
were
included
if
participants
had
advanced
or
metastatic
disease.
Our
primary
analysis
measured
number
research
days
(PRDs;
each
day
a
clinic
visit
is
required)
per
participant
up
to
first
month
participation
entire
duration.
Secondarily,
we
estimated
RESULTS
sample
71
comprising
302
cohorts.
These
enrolled
3,904
participants;
median
duration
was
2.5
months.
During
screening
participation,
PRDs
7
(IQR,
7-10).
Across
trial,
4.5
3.30-6.20).
Participants
spent
15%
attending
appointments.
Per
cohort,
given
8
7-11)
physical
examinations,
6
3-10)
infusions,
3-12)
electrocardiograms,
1
1-3)
biopsy.
CONCLUSION
commit
substantial
amount
trials,
especially
month.
Overall,
they
invest
activities.
estimates
provide
lower
bound
donate
drug
development,
as
our
excluded
unplanned
visits.
JAMA Network Open,
Journal Year:
2024,
Volume and Issue:
7(11), P. e2447649 - e2447649
Published: Nov. 27, 2024
Importance
Cancer
and
its
care
impose
significant
time
commitments
on
patients
partners.
The
oncology
community
has
only
recently
conceptualized
these
the
associated
burden
as
“time
toxicity”
of
cancer
care.
As
concept
gains
traction,
there
is
a
critical
need
to
fundamentally
understand
perspectives
multiple
stakeholders
burdens
Objectives
To
explore
time-consuming
aspects
that
were
perceived
burdensome,
identify
individuals
most
affected
by
care,
evaluate
consequences
burdens.
Design,
Setting,
Participants
in
this
qualitative
analysis
recruited
from
National
Institute–designated
center
Minnesota,
where
semistructured
interviews
conducted
February
1
October
31,
2023.
Purposive
criterion
sampling
methods
used
recruit
(adults
with
advanced
stage
gastrointestinal
receiving
systemic
cancer-directed
treatment),
partners
(patient-identified
informal
[unpaid]
partners),
clinicians
(physicians,
physician
assistants,
nurse
practitioners,
nurses,
social
workers,
schedulers).
Data
analyzed
2023
2024.
Main
Outcomes
Measures
Thematic
was
hybrid
(inductive
deductive
methods)
approach.
Themes,
subthemes,
illustrative
quotations
are
presented.
Results
Interviews
included
47
participants
(16
[8
aged
≤60
years;
12
women
(75.0%)],
15
[12
9
(60.0%)],
16
[11
(68.7%)]).
A
total
31
subthemes
identified
grouped
into
5
themes.
Theme
captured
due
health
outside
home
(eg,
travel,
parking,
waiting
time),
while
theme
2
often
invisible
tasks
performed
at
handling
insurance
medical
bills,
formal
home-based
care).
3
explored
how
alongside
extending
wider
network
family,
friends,
community)
4
represented
demoralization,
seemingly
short
visits
turned
all-day
affairs).
Finally,
referenced
positive
spent
clinical
interactions
hope
for
change
value
meaningful
label
spark
change).
Conclusions
Relevance
This
identifies
key
sources
effects
toxicity,
well
populations
affected.
results
study
will
guide
map,
measure,
address
future
JCO Oncology Practice,
Journal Year:
2025,
Volume and Issue:
21(1), P. 41 - 51
Published: Jan. 1, 2025
Adverse
financial
burden
and
its
effect
on
patients
resulting
from
the
costs
associated
with
cancer
care,
both
direct
indirect,
is
known
as
toxicity.
This
review
explores
interplay
between
toxicity
key
social
legal
needs
in
care.
Drawing
WHO's
framework
ASCO's
policy
statement
determinants
of
health,
we
propose
a
conceptual
model
that
discusses
five
needs—housing
insecurity,
food
transportation
access
barriers,
employment
disruptions,
psychosocial
needs—which
interact
with,
are
affected
by
toxicity,
adversely
influence
patients'
well-being
adherence
to
treatment.
We
literature
addressing
scope
each
these
needs,
their
cancer,
how
increases
overall
There
an
emphasis
patient
caregiver
one
unit
navigating
through
treatment
together.
The
aim
guide
interventions
at
patient-provider,
institutional,
levels
alleviate
improve
care
delivery
for
caregivers
underappreciated
needs.
Cancer,
Journal Year:
2025,
Volume and Issue:
131(6)
Published: March 12, 2025
This
commentary
reviews
the
experiences
of
caregivers
in
early‐phase
clinical
trial
settings
by
illuminating
their
significant
emotional
distress,
limited
role
preparation,
and
substantial
logistical
financial
burdens.
Comprehensive
strategies
to
strengthen
supports
for
these
are
proposed,
including
timely
mental
health
screening
intervention,
active
engagement
discussions,
concrete
delineation
trial‐specific
caregiving
responsibilities,
decentralization.
JAMA Network Open,
Journal Year:
2025,
Volume and Issue:
8(3), P. e250778 - e250778
Published: March 13, 2025
Importance
Contact
days—days
with
health
care
contact
outside
the
home—are
a
measure
of
how
much
patient’s
life
is
consumed
by
care.
Clinical
trials,
more
uniform
patient
mix
and
protocolized
care,
provide
unique
opportunity
to
assess
whether
burdens
differ
individuals’
sociodemographic
backgrounds.
Objective
To
characterize
patterns
days
for
older
adults
cancer
participating
in
clinical
trials.
Design,
Setting,
Participants
In
this
cohort
study,
data
from
6
SWOG
Cancer
Research
Network
trials
across
prostate,
lung,
pancreatic
cancers
that
recruited
patients
aged
65
years
or
1999
2014
were
linked
Medicare
claims
data.
Data
analyzed
December
14,
2023,
September
26,
2024.
Exposures
Demographic
variables,
including
age,
sex,
self-reported
race
ethnicity,
insurance
status;
factors,
such
as
type
study-specific
prognostic
risk
score;
social
neighborhood
socioeconomic
deprivation.
Main
Outcomes
Measures
Number
days,
defined
number
system,
percentage
(number
divided
follow-up),
sources
(eg,
ambulatory
inpatient)
first
12
months
after
trial
enrollment.
Sociodemographic
factors
associated
examined
using
negative
binomial
regression,
an
offset
variable
duration
observation.
Results
The
study
included
1429
(median
71
[range,
65-91
years];
1123
men
[78.6%];
332
[23.5%]
rural
residence).
median
was
48
(IQR,
26-71),
350
178-365
days)
observation;
19%
13%-29%).
most
common
clinician
visits
(median,
17
[IQR,
7-25]),
tests
3-24]),
treatments
11
3-22]).
A
70%
50%-88%)
had
only
single
service
performed
on
day
tests).
multivariable
increased
age
(relative
[RR]
per
year,
1.02
[95%
CI,
1.01-1.02]),
(Medicare
alone
Medicaid
private
vs
other:
RR,
2.47
2.16-2.83]),
score
(above
at
below
median:
1.14
1.04-1.25]),
(pancreatic
prostate
cancer:
1.69
1.51-1.89];
lung
1.54-1.85]).
Conclusions
Relevance
advanced
stage
phase
3
randomized
spent
nearly
1
5
contact.
These
findings
highlight
need
simplify
requirements
minimize
participant
burden.
JAMA Network Open,
Journal Year:
2025,
Volume and Issue:
8(4), P. e255033 - e255033
Published: April 15, 2025
Importance
Although
patients
enrolled
in
trials
have
superior
survival
outcomes
compared
with
those
routine
practice,
it
is
unknown
whether
such
differences
extend
to
contact
days,
a
measure
of
time
toxicity.
Objective
To
evaluate
days
for
advanced
stage
non–small
cell
lung
cancer
(NSCLC)
receiving
care
or
practice.
Design,
Setting,
and
Participants
This
population-based,
retrospective,
matched
cohort
study
assessed
adults
from
Ontario,
Canada,
who
were
diagnosed
advanced-stage
NSCLC
between
January
1,
2010,
December
31,
2017,
died
2019.
The
maximum
follow-up
diagnosis
was
2
years.
Data
analysis
performed
May
5,
2024,
October
22,
2024.
Exposure
Patients
specific,
systemic,
palliative-intent,
cancer-directed
drug(s)
as
part
trial
1:1
received
the
same
after
approval
practice
line
treatment.
Main
Outcomes
Measures
Contact
(days
in-person
health
contact)
identified
through
administrative
claims
data.
Models
fitted
cubic
splines
describe
trajectories
weekly
percentage
days.
Results
Of
250
(mean
[SD]
age,
63.6
[9.2]
years;
140
[56.0%]
male),
125
participants
Trial
younger
(median
[IQR]
63
[56-69]
years
vs
64
[58-70]
patients;
standardized
difference,
0.21)
had
fewer
comorbidities
(eg,
hypertension
[45
(36.0%)
59
(47.2%);
0.23]).
Median
(IQR)
death
higher
(79
[62-104]
68
[46-98]
days;
0.26).
However,
longer
median
overall
12.8
[8.7-18.0]
10.5
[5.2-14.7]
months;
0.46)
slightly
lower
adjusting
(20.3%
[95%
CI,
18.1%-21.7%]
21.2%
19.3%-25.7%]).
During
treatment,
experienced
(18.4%
16.3%-20.8%]
25.5%
20.7%-30.3%]);
inpatient
accounted
18.5%
(95%
11.1%-29.6%)
on-treatment
40.0%
30.0%-47.6%)
Normalized
contact-day
U-shaped
all
groups,
peaks
troughs
among
participants.
Conclusions
Relevance
In
this
population-based
study,
systemic
therapy
by
greater
hospitalization
rates
Addressing
predominantly
outpatient,
protocol-mandated
visits
may
represent
opportunities
decrease
trial-related
Journal of Clinical Oncology,
Journal Year:
2024,
Volume and Issue:
42(33), P. 3986 - 3995
Published: July 30, 2024
Strategies
to
bring
clinical
trials
closer
patients
gained
momentum
during
the
COVID-19
pandemic,
enabling
more
participants
receive
treatment
and/or
testing
in
their
local
communities.
Incorporation
of
decentralized
trial
elements
presents
both
opportunities
and
challenges,
spanning
regulatory,
technical,
operational
aspects.
This
ASCO
research
statement
includes
timely
consensus-driven
recommendations
a
call
for
engagement
all
stakeholders.
held
multistakeholder
meetings
with
leaders
oncology
concluded
that
research-related
regulatory
administrative
requirements
burdens
present
critical
barriers
decentralizing
trials.
One
example
is
sponsor
contract
organization
(CRO)
use
US
Food
Drug
Administration
(FDA)'s
Statement
Investigator
(Form
1572),
which
was
found
exceed
FDA's
stated
intent
used
conservative
ways
disproportionate
potential
risks
scientific
integrity.
As
result,
sites
experience
an
avalanche
downstream
activities
consume
considerable
resources.
recommends
four
key
solutions
address
such
recalibrate
expectations
trials:
(1)
FDA
should
engage
community
public-private
partnership
modernize
standards
enable
access
trials;
(2)
sponsors
CROs
develop
protocols
accommodate
flexible
approaches,
participation,
provide
clarity
around
roles
requirements,
promote
consistency;
(3)
centers,
networks,
update
policies
procedures
implement
elements;
(4)
streamlined,
uniform
mechanism
simplify
data
collection
documentation
it
consistently
across
We
can
must
prioritize
concerted
commitment
streamline
practices
broaden
participation
cancer
