Authors’
judgment |
Unclear
risk |
Low
risk |
Unclear
risk |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Dieli-
Conwright 2018a |
Support
for judgment |
Two-arm
randomized controlled trial compared a progressive combined-aerobic and
resistance-exercise intervention with usual care |
Participants
were randomly assigned (block size = 10 patients) to exercise or usual care
after baseline testing using concealed randomization lists. |
Information
concerning the blinding of participants was not provided |
Information
concerning the blinding of the assessor was not provided |
Four patients
in the intervention group did not complete the study post- intervention:
two lost to follow-up and two patients were unreachable. Five patients in
the control group did not complete the study post-intervention: Three lost
to follow up and two patients were unable to post-test as a result of a
work conflict. Intention-to-treat analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Unclear
risk |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Dieli-
Conwright 2018a |
Support
for judgment |
Two-arm
randomized controlled trial compared a progressive combined-aerobic and
resistance-exercise intervention with usual care |
Participants
were randomly assigned (block size = 10 patients) to exercise or usual care
after baseline testing using concealed randomization lists |
Information
concerning the blinding of participants was not provided |
Information
concerning the blinding of the assessor was not provided |
Four patients
in the intervention group did not complete the study post- intervention:
two lost to follow-up and two patients were unreachable. Five patients in
the control group did not complete the study post-intervention: Three lost
to follow up and two patients were unable to post-test as a result of work
conflict. Intention-to-treat analysis was applied. |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Dieli-
Conwright 2018a |
Support
for judgment |
The participants
were randomly assigned to either the exercise or control group, and scheduled
for the baseline visit. Randomization was performed by the Clinical Investigation
Support Office (CISO) at the USC NCCC |
To prevent
possible bias, study personnel involved in the recruitment did not have
access to the randomization lists; the biostatistician who developed the
randomization list did not have any patient contacts to influence the recruitment
and allocation procedure |
The participants
were blinding |
The assessor
was blinding |
One patient
in the intervention dropped out due to the group lost to follow-up. Intention-to-treat
analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Unclear
risk |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Dieli-
Conwright 2018a |
Support
for judgment |
This two-arm
randomized controlled trial compared a progressive combined—aerobic
and resistance—exercise intervention with usual care |
Participants
were randomly assigned (block size = 10 patients) to exercise or usual care
after baseline testing using concealed randomization lists |
Information
concerning the blinding of participants were not provided |
Information
concerning the blinding of the assessor was not provided |
four patients
of the intervention group did not complete the study post-intervention:
two lost to follow-up and two patients were unreachable. Five patients in
the control group did not complete the study post- intervention: Three lost
to follow up and two patients were unable to post-test as a result of work
conflict. Intention-to- treat analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Unclear
risk |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Dieli-
Conwright 2019 |
Support
for judgment |
This two-arm
randomized controlled trial compared a progressive combined—aerobic
and resistance—exercise intervention with usual care. |
Participants
were randomly assigned (block size = 10 patients) to exercise or usual care
after baseline testing using concealed randomization lists |
Information
concerning the blinding of participants were not provided |
Information
concerning blinding of participants were not provided |
All the
participants completed the study |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Unclear
risk |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Dieli-
Conwright 2019 |
Support
for judgment |
Randomized
control trial comparing a weight loss intervention to usual care. |
Participants
were randomly assigned (block size = 10 patients) to exercise or usual care
after baseline testing using concealed randomization lists |
Information
concerning the blinding of participants were not provided |
Information
concerning the blinding of the assessor was not provided |
All the
participants completed the study |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
High
risk |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Dieli-
Conwright 2022 |
Support
for judgment |
A randomized
trial comparing a weight loss intervention to usual care. |
Twenty-five
participants were randomly assigned to intervention and control groups after
baseline testing using concealed randomization lists |
Participants
were not blinded to intervention assignment |
Information
concerning the blinding of the assessor was not provided |
All the
participants completed the study |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Brown
2021 |
Support
for judgment |
Participants
were randomly assigned in an equal ratio to intervention and control groups |
After baseline
testing, participants were allocated into two groups and were randomized
using a computerized covariate adaptive procedure |
Participants
were blinding |
The assessor
was blinding |
All the
participants completed the study |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
High
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Ergun
2013 |
Support
for judgment |
Participants
were randomly assigned in an equal ratio to intervention and control groups. |
After baseline
testing, participants were allocated into two groups and were randomized
using a computerized covariate adaptive procedure |
Participants
were not blinded to intervention assignment |
The assessor
was blinding |
All the
participants completed the study |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Rogers
2013 |
Support
for judgment |
A randomized
controlled trial compared an intervention with a control group. Randomization
was based on computer-generated numbers, performed in blocks of 4, and revealed
in the order in which participants completed baseline testing |
Allocation
was concealed by central randomization and only revealed after baseline
assessment |
Participants
were blinded |
The assessor
was blinding |
One patient
in the intervention group lost to follow-up due to lack of time. One patient
in the control group dropped out when asked to repeat a blood draw. Intention-to-treat
analysis was applied. |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Rogers
2014 |
Support
for judgment |
This two-arm
randomized controlled trial compared an intervention with a control group
using, randomization was done in blocks of four based on computer generated
numbers. |
Randomization
numbers were kept in sealed, opaque envelopes so that study staff and participants
were unaware of group allocation until all baseline testing was complete. |
Participants
were blinded |
ALL measures
were obtained by individuals who were blinded to the participant's study
group allocation |
Two participants
developed cancer recurrence during the trial (both in the intervention group).
These two participants were dropped from the analysis for scientific reasons.
Two patients in the control group dropped out due to the lack of time. Intention-to-treat
analysis was applied. |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Rogers
2014 |
Support
for judgment |
This two-arm
randomized controlled trial compared an intervention with a control group,
using randomization that was conducted in blocks of four based on computer
generated numbers |
Randomization
numbers were kept in sealed, opaque envelopes so that study staff and participants
were unaware of group allocation until all baseline testing was complete. |
Participants
were blinded |
ALL measures
were obtained by individuals who were blinded to the participant's study
group allocation |
Two participants
developed cancer recurrence during the trial (both in the intervention group).
These two participants were dropped from the analysis for scientific reasons.
Two patients in the control group dropped out due to the lack of time. Intention-to-treat
analysis was applied. |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Unclear
risk |
High
risk |
Unclear
risk |
Unclear
risk |
Low
risk |
Low
risk |
Hutnick
2005 |
Support
for judgment |
patients
with breast cancer were assigned to intervention and control groups. |
36 patients
with breast cancer were enrolled in a 6-month moderate exercise program
very soon after completing chemotherapy or radiation treatment to the intervention
and control group. |
Participants
were not blinding |
Information
concerning the blinding of the assessor was not provided. |
Seven patients
in the intervention group dropped out. Six patients in the control group
dropped out after the midpoint of the study. However, the reasons for this
were not explained. Intention-to-treat analysis was applied. |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Low
risk |
High
risk |
Low
risk |
Low
risk |
Low
risk |
Battaglini
2007 |
Support
for judgment |
The participants
were randomly assigned to exercise or control group |
The patients
had to choose a number between 1 and 20 for the allocation process. Even-numbered
participants were assigned to the experimental group, whereas odd-numbered
participants were assigned to the control group |
Participants
were blinding |
The assessor
was not blinding. |
All the
participants completed the study. |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Low
risk |
Low
risk |
High
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Mutrie
2007 |
Support
for judgment |
The study
was a two-group (intervention and control) by three time points (baseline,
12 weeks, and six-month follow-up) randomized controlled trial. The randomization
was stratified by hospital and treatment at baseline and used randomized
permuted blocks of length four and six (that is, for sequences of four or
six women in each hospital-treatment combination, exactly half were allocated
to each group). |
After written
informed consent and baseline measures, participants were randomly allocated
women into one of two groups using randomization list. |
Blinding
of the participants was not possible |
The assessors
were blinding |
14 patients
in the intervention group did not complete the study: Seven patients were
lost to follow-up, four patients did not return the questionnaire, one patient
was too ill, and two patients were not contactable. Eight patients in the
control group did not complete the study: Four patients were lost to follow-up,
two patients did not return the questionnaire, one died, and one withdrew.
Intention-to-treat analysis was applied. |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Nieman
1995 |
Support
for judgment |
Sixteen
female breast cancer patients between the ages of 35 and 72 years were recruited
for the study |
After written
informed consent and baseline measures, Subjects were randomly assigned
to either an exercise or control group. |
The participants
were blinding |
Information
concerning the blinding of the assessor was not provided |
Two patients
(one from each group did not complete the study, because of the recurrence
of the disease. Intention-to-treat analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Low
risk |
High
risk |
Low
risk |
Low
risk |
Low
risk |
Ligibel
2008 |
Support
for judgment |
101 sedentary,
overweight breast cancer survivors were randomly assigned either to exercise
intervention or to a usual care control group |
After enrolment,
participants were randomly assigned 1:1 to an exercise intervention group
or control group |
The participants
were blinding |
Participants
underwent a series of anthropometric measurements at the time of study enrolment
(baseline), and these were repeated after the 16-week study period by study
staff who were not blinded to group assignment |
11 patients
in the intervention group did not complete the study for the following reasons:
Two lost to follow-up, one had a family emergency, three had too much of
a time commitment, one was too ill for final, one had a disease recurrence,
one developed unrelated cancer, one withdrew consent, and one need for unrelated
surgery. Seven patients in the control group did not complete the study
for the following reasons: Three lost to follow-up, two had disease recurrence,
one withdrew upon assignment to the control group, and one for family problems.
However, intention-to-treat analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Low
risk |
High
risk |
Low
risk |
Low
risk |
Low
risk |
Ligibel
2008 |
Support
for judgment |
101 sedentary,
overweight breast cancer survivors were randomly assigned either to exercise
intervention or to a usual care control group |
After enrolment,
participants were randomly assigned 1:1 to an exercise intervention group
or control group |
The participants
were blinding |
Participants
underwent a series of anthropometric measurements at the time of study enrolment
(baseline), and these were repeated after the 16-week study period by study
staff who were not blinded to group assignment |
11 patients
in the intervention group did not complete the study for the following reasons:
Two lost to follow-up, one had a family emergency, three had too much of
a time commitment, one was too ill for final, one disease recurrence, one
developed unrelated cancer, one withdrew consent, and one need for unrelated
surgery. Seven patients in the control group did not complete the study
for the following reasons: Three lost to follow-up, two disease recurrence,
one withdrew upon assignment to the control group, and one for family problems.
However, intention-to-treat analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Ligibel
2019 |
Support
for judgment |
Participants
were randomized 1:1 to an exercise and control group. All participants were
randomized through the Quality Assurance for Clinical Trials (QACT) Core
at Dana-Farber, which served as the coordinating center of the study. |
After baseline
measures 48 participants were randomly assigned to an exercise intervention
group or control group |
The participants
were blinding |
The assessor
was blinding |
One patient
in the intervention group was found to be ineligible after randomization
and two patients in the control group withdrew consent after randomization.
Intention-to-treat analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Jones
2020 |
Support
for judgment |
A quasi-randomized
design where each group comprised exercising or non-exercising breast cancer
survivors of similar age and treatment characteristics |
A simple
randomization procedure using the number on entry to allocate women as they
entered the trial, on a 1:1 basis, was undertaken. Breast cancer survivors
with odd numbers began the 12-week exercise treatment protocol immediately,
while even-numbered women acted as wait-listed, non- exercising controls.
The control women could access the intervention protocol after their testing
in week 13. None of the authors were involved in the recruitment of the
participants. |
The participants
were blinding |
The assessor
was blinding |
Three control
participants did not complete data collection, one incurred an ankle injury
(not intervention-related), one moved to another town, and one chose to
withdraw before any baseline measures. Intention-to-treat analysis was applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Unclear
risk |
Low
risk |
Unclear
risk |
Unclear
risk |
Low
risk |
Low
risk |
Low
risk |
Lee
2019 |
Support
for judgment |
This randomized
clinical trial compared an aerobic and resistance exercise intervention
with usual care. |
For each
patient recruited into the study, written informed consent is obtained before
performing randomization or outcome measure testing. Upon written informed
consent, the patient is randomly allocated to either the Exercise or Control
groups. To prevent possible bias, study personnel involved in the recruitment
and allocation did not have access to the randomization lists |
Information
concerning the blinding of the participants was not provided. |
Information
concerning the blinding of the assessor was not provided |
Three patients
in the intervention group did not complete the study for the following reasons:
Two had Work conflicts, and one had disease progression. Three participants
in the control group lost to follow-up post-intervention for the reasons:
one family emergency, and two unreachable. Intention-to-treat analysis was
applied |
Expected
outcomes were reported |
Other biases
have not been identified |
Authors’
judgment |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Low
risk |
Saxton
2014 |
Support
for judgment |
A total
of 85 women treated for breast cancer 3 to 18 months were randomly allocated
to a 6-month to exercise and control group. Randomization was performed
by an independent researcher at the Clinical Trials Research Unit, University
of Leeds |
A total
of 85 women treated for breast cancer 3 to 18 months were randomly allocated
to a 6-month to exercise and control group. Randomization was performed
by an independent researcher at the Clinical Trials Research Unit, University
of Leeds. The randomization sequence and allocation were not disclosed until
patients had completed their baseline assessments |
The participants
were blinding |
|