Welcome to the Data Extraction Form for the Scoping Survey: Research Intervention "Pretreatment Activity and Rehabilitation for neoAdjuvant Gynecology Oncology Patients" (PARAGON)
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Please enter reviewer initials
Please enter the last name of the first author
Please enter the Title of the Article:
Please select the year the study was published:
Please Select
2023
2022
2021
2020
2019
2018
2017
2016
2015
2014
2013
Was the study design an experimental study design ( an intervention was tested versus observed) ?
Please Select
Yes
No
If yes pick one:
Please Select
RCT
Pilot Study
Quasi Experimental
Single Group Pre-Post
Other
If your answer was "Other" above please answer here
What was the Observational Study Design?
Please Select
Cohort Longitudinal
Cohort Repeated Measures
Retrospective Cohort
Cross Sectional
Case Control
Case Series
Other
If you answered "other" above please explain here:
Observational study descriptions if needed - OPTIONAL
If the study was a review please select which type:
Please Select
MetaAnalysis
Systematic Review
Clinical Practice Guidelines
Scoping Review
Other
If you answered Other above please explain here:
The primary aim of the study was to determine the:
Efficacy
Effectiveness
Feasibility
Feasibility with Implementation
Pilot Study to determine the processes and assess the outcomes of the intervention
Usability
Other
If the study focused on one type of cancer please choose one:
Lung Cancer
Gynecological
Uterine
Ovarian
Esophageal
Head or Neck Region
GI Upper
GI Lower
Bladder
Prostate
Liver
Other
If you answered Other above please explain here:
If the study had more than one type of cancer please select all that apply
Add additional cancers if not included above
Was there any blinding in the study?
Please Select
Yes
None
Subjects Blinded
Subjects and Researchers Blinded
Data Analysts were blinded
Other
If you answered "other" above please clarify here:
Was there a control group?
Yes
No
Other
What was the control group condition?
Active
Waitlist
Usual care
N/A (single group study)
Other
If "other" please respond here:
Was the study's primary functional outcome measure Performance based or based on a Patient Reported Outcome Measure (PROM)
Patient Reported Outcome Measure (including function and quality of life measures, surveys, questionnaires)
Performance Based Quantitative Functional Outcome Measures e.g. six minute walk test
Other
If your answer was "Other" above please answer here
If the study reported a primary outcome measure please choose it here:
Please Select
Gyn Cancer Quality of Life (Functional Assessment of Cancer Therapy - General (FACT-G)
SF-36
Gyn Cancer Symptoms (Symptoms Representation Questionnaire (SRQ)
Gyn Cancer Quality of Life (Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
IPAQ (International Physical Activity Questionnaire)
PROMIS Ability
PROMIS Social Role Function
PROMIS Physical Function
6MWT (distance)
4MWT
Fatigue Scale
Cancer QOL
Falls
Timed up and Go (TUG)
Steps
Shuffling Test
Gait Speed
Gait Velocity
Balance (Single Leg Stance)
Balance other
Other
Frequently this is the outcome used to determine sample size
If “other” respond here:
If the primary outcome measure was performance based please choose it here:
6MWT
4MWT
TUG
Steps
Shuffling Test
Gait Speed
Gait Velocity
Physical Activity Tracking via Fitbit or Other Wearable Device
Balance Other
Other
N/A
If additional performance based measures were collected please select all that apply:
6MWT
4MWT
TUG
Steps
Shuffling Test
Gait Speed
Gait Velocity
Physical Activity Tracking via Fitbit or Other Wearable Device
Balance Other
Other
N/A
If the primary outcome measure was a Patient Reported Outcome Measure or a HQOL please choose that here:
Gyn Cancer Quality of Life (Functional Assessment of Cancer Therapy - General (FACT-G)
SF-36
IPAQ (International Physical Activity Questionnaire)
PROMIS Ability
PROMIS Social Role Function
PROMIS Physical Function
Pain Scale
Fatigue Scale
Falls
MOS
MDASI
Self-Efficacy
European Organization for Research and Treatment of Cancer
Cancer Specific HRQOL
Activity Card Sort
Gyn Cancer Symptoms (Symptoms Representation Questionnaire (SRQ)
Gyn Cancer Quality of Life (Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
Other
N/A
If there were additional outcome measures that were Health and Quality of Life Surveys (HQOLs) or Patient Reported Outcome Measures please check all that apply:
Gyn Cancer Quality of Life (Functional Assessment of Cancer Therapy - General (FACT-G)
SF-36
IPAQ (International Physical Activity Questionnaire)
PROMIS Ability
PROMIS Social Role Function
PROMIS Physical Function
Pain Scale
Fatigue Scale
Falls
MOS
MDASI
Self-Efficacy
European Organization for Research and Treatment of Cancer
Cancer Specific HRQOL
Activity Card Sort
Gyn Cancer Symptoms (Symptoms Representation Questionnaire (SRQ)
Gyn Cancer Quality of Life (Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
Other
N/A
Implementation Outcomes:
Patient Satisfaction
Completion Rate >70%
Completion Rate < 50%
Patient Adherence
Acceptability
Other
If other please describe here:
Any other outcomes
Exercise capacity
Max VO2
Dyspnea Scale
Other
Was there more than 1 experimental condition (e.g. more than one intervention tested) Please click the drop downs to make your choices. What is shown is the default
If you answered “other” above please explain here:
How many times did the study collect interim data, or take assessments before the "post" assessment?
Was the program called a Prehabilitation Program
yes
no
If no what was the intervention approach called e.g. "multimodal sports science approach"
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What was the total N enrolled in the Study?
Were the two groups' data separated in the study? This answer will provide the appropriate questions for you in the rest of the form:
yes
no
There were 3 groups
Other
Group 1 enrolled N
Group 2 enrolled N
What was the sample gender?
Please Select
Female
Male
Female and Male Included
Other
N/A
Total Sample Mean Age
Total Sample Mean Age SD
If data listed for 2 groups separately simply enter the data here for the 2 groups:
Group 1
Group 2
Enrolled N
Mean Age
SD
Total N Female
Total N Male
Is race reported in demographic table?
Yes
No
Other
% White/Caucasian in total sample
List any additional information about age (Sample age by group, Median age, etc.)
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Was the intervention or program prior to surgery, chemo or both?
Choose from the Drop-down Menu
Prior to Surgery
Prior to Chemo
Prior to Radiation
Prior to chemo and Surgery
Prior to NeoAdjuvant Chemo
Prior to Neoadjuvant chemo and surgery
N/A
Intervention Exercise Components components check all that apply
Blood Flow Restriction Exercise
Spontaneous Physical Activity
Walking with Resistance bands
Walking
Strength Training
Rowing
Endurance Training
Personalized Program
Exercise Training
Other
Other Interventional Components Check all that apply
What were the other intervention components added that we have not included?
Were there any web based options check all that apply
Please Select
Yes
No
Completely web based
Web based and Exercise based
Partially Web Based
Other
If other please explain here:
Was there a remote option available? Please select those that apply
If other or there was some other version of support offered to participants during the intervention please describe here:
What was the clinical specialty of the leading interventionist (pick one)?
Exercise physiologist
PT
PT Assistant
OT
OT Assistant
SLP
Rehab MD
Rehab Psych
Social work
Counselling
Nurse
Physician
PA
RA/GA healthcare professional
Nutrition
Dietetics
Not specified
Other
If there were other disciplines included besides the individual primary interventionist check all that apply
If you answered other above please explain here:
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Length (Duration of Intervention
Please Select
< 1 week
1-2 weeks
2-4 weeks
4-6 weeks
6-8 weeks
8-12 weeks
> 12 weeks
Other
If you chose other specify here:
Frequency of Intervention please choose one, if other an option will appear for further explanation:
Ramped - It was increased over time
3 times per day
Twice a day
Throughout the day
Daily
5-6x per week
3 x per week
3-4x per week
twice a week
once a week
Other
How did the researchers measure the DOSEAGE of the chosen intervention activity? Which was used as their dose measurement?
If you chose other above please specify here:
Intensity of Intervention
Please Select
Fixed
Variable
Ramped
65–85% of Maximum HR based on age
>13 Intensity According to the Borg Scale
Borg scales of = 2
Borg scales of = 3–5
Borg scales of = 6
Exertional Scale
Dyspnea scale
Perceived exertion
Heart Rate
% oxygen
% Body weight
% max weight rep
at least 60 minutes
1 set of 10 reps
2x 10 reps
3x 10 reps
OTHER
How did they measure intensity or how difficult the intervention was? What did they use to determine if it should be made more difficult or easier?
If you answered "other" :for Intensity please describe here
How was the intervention adjusted over time if it was? Did they adjust the activity in terms of difficulty and in response to what measure or did they use a protocol? Published or otherwise?
Adjusted according to published protocol
Adjusted per Epley
Ramped based on time per session
Other
Add other methods of how the intervention was adjusted if necessary.
List comments or concerns about the intervention dose. Please click the + button to add more:
What was the setting?
Outpatient
Outpatient Hospital Based
Hospital Based
Home Based
Community Program
Other
Please describe setting if not enough space above:
Prehabilitation under the guidance of which of the following?
Please Select
Physical Therapist
Occupational Therapist
Nurse
Patient
Exercise physiologist
RA Expert not specified
Rehabilitation Physician
supervised
Expert not specified
Not Supervised
Independent
Other
If there was an exercise group, please pick from these options to best describe the organization. If more than one apply - select all. If you select "other" there will be an option to write in your own.
Exercise (Independent)
Exercise 1-1
Exercise (Group)
Group < 3
Group 3-10,
Community Group Number Unknown
Self Management
Other
Time until surgery
Please Select
< 1 week
1-2 Weeks
2-4 weeks
> 4 weeks
Other
If Other Specify Here:
Time until NeoAdjuvant Chemotherapy
Please Select
< 1 week
1-2 Weeks
2-4 weeks
> 4 weeks
Other
NeoAdjuvant Chemo is chemo provided prior to surgery or radiation to reduce tumor size.
If Other Specify Here:
Time until radiation or other treatment
Please Select
< 1 week
1-2 Weeks
2-4 weeks
> 4 weeks
Other
If Other Specify Here:
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What statistical analysis was used for clinical outcomes?
One sample T test
Independent T test
Paired samples T-test(repeated measures t-test)
Multivariate Regression Analysis
ANOVA with matched groups
Standard ANOVA
Repeated measures ANOVA
Pearson's chi-squared test
Reliability Tests
Tests for non-normal data
Other
Based on BETWEEN GROUP differences, outcome measure #1…Choose the combination of factors that best describes the statistical and clinical findings of the study's primary outcome measure.
Based on WITHIN GROUP Differences, Functional Outcome Measure 1#....Choose the combination of factors that best describes the statistical and clinical findings of the study's primary outcome measure.
If there are additional outcomes and important statistical outcomes or clinically significant outcomes please include here and click add for additional findings.
Based on BETWEEN GROUP Differences, HQOL/PROM Outcome Measure # 1…Choose the combination of factors that best describes the statistical and clinical findings of the study's primary outcome measure.
Based on Within Group Differencces, HQOL/PROM Outcome Measure # 1…Choose the combination of factors that best describes the statistical and clinical findings of the study's primary outcome measure.
If there are additional outcomes and important statistical outcomes or clinically significant outcomes please include here and click add for additional findings.
Was there a variable controlled for in analysis? Please list (e.g. NSQIP scores were controlled for)
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List statistically significant differences in demographic or clinical characteristics between intervention groups, or write N/A
List all statistically significant variables between groups (covariates), or write N/A
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Was the Effect Size Calculated?
Yes
No
Unclear
Other
Cancer Specific Quality of Life Survey - Check if Outcome (Effect Size) Matches Any Listed
Physical Well being < .42
Physical Well being .42-.87
Physical Well being > .87
Functional Well Being < .37
Functional Well Being < .71
Functional Well Being < .1.3
Emotional Well Being .32 Small
Emotional Well Being .40 Medium
Social Well Being .14 small
Social Well being .23 Medium
Other
If you answered "other" above please specify here:
Six Minute Walk Test (6MWT) Effect Size (Check if Outcome (change in distance walked) approximates these effects
Was the improvement > 55 meters
Was the improvement < 55 meters
Other
Brief summary of study conclusions
Describe adverse events, if not reported write N/A
List any concerns or comments for the article
Copy-paste intervention protocol from publication if able:
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Calculating Means and Mean differences for Effect size if article did not provide
Should be Empty: