Prehabilitation for Ovarian Cancer Patients
The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Scott Grandy, PhD
- Phone Number: 902-494-1145
- Email: grandy@dal.ca
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3L 4P1
- Recruiting
- Nova Scotia Health
-
Contact:
- Scott Grandy, MD
- Phone Number: 902-494-4303
- Email: scott.grandy@dal.ca
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older
- Have a confirmed diagnosis of stage III or IV ovarian cancer
- Scheduled to receive cytoreductive surgery as part of their treatment plan
- Must have a minimum of 4-weeks between the time of study enrollment and scheduled surgery
- Be able to attend in-person and/or virtual exercise sessions
- Be fluent in English
- Have oncologist approval
Exclusion Criteria:
- Have already completed surgery
- Unstable cardiac or respiratory disease, injury or any other co-morbid disease that may make it unsafe for participants to exercise
- Significant cognitive impairment (e.g., do not have the capacity to consent, unable to follow exercise instructions)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Intervention
Circuit-based prehabilitation exercise intervention
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The exercise intervention will consist of light-to-moderate intensity aerobic, resistance, and mobility exercises.
These exercises will be performed in a circuit type manner.
Participants will perform similar exercises that are modified to meet their individual abilities.
Exercise intensity, modifications and substitutions will be determined for each participant based on their medical history, 6 minute walk test results, and baseline frailty scores.
Exercise sessions will be performed 3x/wk beginning at 30 min and progressing to 60-min as tolerated for a minimum of four weeks but will continue up until the time of the participants surgery.
A hybrid approach will be used for the exercise sessions whereby the participant must attend the first exercise session in person and subsequent sessions will be delivered virtually.
Sessions will be overseen by the study Clinical Exercise Physiologist.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frailty Change (baseline to post exercise intervention)
Time Frame: Change from baseline to end of 4+ week intervention (pre-surgery)
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Frailty will be assessed using the Clinical Frailty Scale (CFS).
The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual.
The CFS covers domains of mobility, energy, physical activity, and function.
The higher the score on the CFS the more frail/less fit an individual is.
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Change from baseline to end of 4+ week intervention (pre-surgery)
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Frailty Change (baseline to 1-month post surgery)
Time Frame: Change from baseline to about 1-month post-surgery
|
Frailty will be assessed using the Clinical Frailty Scale (CFS).
The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual.
The CFS covers domains of mobility, energy, physical activity, and function.
The higher the score on the CFS the more frail/less fit an individual is.
|
Change from baseline to about 1-month post-surgery
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Frailty Change (baseline to 3-months post surgery)
Time Frame: Change from baseline to about 3-month post-surgery
|
Frailty will be assessed using the Clinical Frailty Scale (CFS).
The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual.
The CFS covers domains of mobility, energy, physical activity, and function.
The higher the score on the CFS the more frail/less fit an individual is.
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Change from baseline to about 3-month post-surgery
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Surgical Complexity Score (1-month post surgery)
Time Frame: Surgical complexity will be assessed about 1-month post-surgery.
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Surgical complexity will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines.
Complexity scores will be interpreted as "low" (3 or fewer points), "intermediate" (4-7 points), and "high" (8 or more points).
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Surgical complexity will be assessed about 1-month post-surgery.
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Post-Surgical Outcomes (1-month post surgery)
Time Frame: Post-surgical outcomes will be assessed about 1-month post-surgery.
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Post-surgical outcomes will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines.
Specific outcomes will include post-op glucose control, analgesia usage, pain, daily weight, early mobilization, and post-operative complications.
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Post-surgical outcomes will be assessed about 1-month post-surgery.
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Surgical Complications (1-month post surgery)
Time Frame: Surgical complications will be assessed post-surgery about 1-month post-surgery.
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Surgical complications will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines.
Specific outcomes will include length of hospital stay and number of readmissions.
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Surgical complications will be assessed post-surgery about 1-month post-surgery.
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Chemotherapy completion rates (End of Cycle 1)
Time Frame: At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
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At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.
|
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Chemotherapy completion rates (End of Cycle 2)
Time Frame: At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
|
At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.
|
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Chemotherapy completion rates (End of Cycle 3)
Time Frame: At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
|
At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates (End of Cycle 4)
Time Frame: At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
|
At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates (End of Cycle 5)
Time Frame: At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
|
At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.
|
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Chemotherapy completion rates (End of Cycle 6)
Time Frame: At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.
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Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
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At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index Change (baseline to post exercise intervention)
Time Frame: Change in BMI from baseline to post 4+ week exercise intervention
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Weight (kg) and height (m) will be used to calculate BMI
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Change in BMI from baseline to post 4+ week exercise intervention
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Body Mass Index Change (baseline to 1-month post surgery)
Time Frame: Change in BMI from baseline to about 1-month post surgery.
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Weight (kg) and height (m) will be used to calculate BMI
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Change in BMI from baseline to about 1-month post surgery.
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Body Mass Index Change (baseline to 3-months post surgery)
Time Frame: Change in BMI from baseline to about 3-month post surgery.
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Weight (kg) and height (m) will be used to calculate BMI
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Change in BMI from baseline to about 3-month post surgery.
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Aerobic Fitness Change (baseline to post exercise intervention)
Time Frame: Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)
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The six-minute walk will be used to calculate aerobic fitness
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Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)
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Aerobic Fitness Change (baseline to 1-month post surgery)
Time Frame: Change in aerobic fitness from baseline to about 1-month post surgery
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The six-minute walk will be used to calculate aerobic fitness
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Change in aerobic fitness from baseline to about 1-month post surgery
|
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Aerobic Fitness Change (baseline to 3-months post surgery)
Time Frame: Change in aerobic fitness from baseline to about 3-months post surgery
|
The six-minute walk will be used to calculate aerobic fitness
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Change in aerobic fitness from baseline to about 3-months post surgery
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Muscular Fitness Change (baseline to post exercise intervention)
Time Frame: Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery)
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Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.
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Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery)
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Muscular Fitness Change (baseline to about 1-month post surgery)
Time Frame: Change in muscular fitness will be assessed from baseline to 1-month post surgery.
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Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.
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Change in muscular fitness will be assessed from baseline to 1-month post surgery.
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Muscular Fitness Change (baseline to about 3-months post surgery)
Time Frame: Change in muscular fitness will be assessed from baseline to 3-months post surgery.
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Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.
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Change in muscular fitness will be assessed from baseline to 3-months post surgery.
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Health-Related Quality of Life Change (baseline to post exercise intervention
Time Frame: Chang in health-related quality of life from baseline to post 4+ week intervention (pre-surgery)
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Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L).
The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems
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Chang in health-related quality of life from baseline to post 4+ week intervention (pre-surgery)
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Health-Related Quality of Life Change (baseline to 1-month post surgery)
Time Frame: Chang in health-related quality of life from baseline to about 1-month post surgery
|
Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L).
The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems
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Chang in health-related quality of life from baseline to about 1-month post surgery
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Health-Related Quality of Life Change (baseline to 3-months post surgery)
Time Frame: Change in health-related quality of life from baseline to about 3-months post surgery
|
Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L).
The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems
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Change in health-related quality of life from baseline to about 3-months post surgery
|
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Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)
Time Frame: Change in FACT-O from baseline to post 4+ week intervention (pre-surgery)
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The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.
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Change in FACT-O from baseline to post 4+ week intervention (pre-surgery)
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Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 1-month post surgery)
Time Frame: Change in FACT-O from baseline to about 1-month post surgery
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The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.
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Change in FACT-O from baseline to about 1-month post surgery
|
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Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 3-months post surgery)
Time Frame: Change in FACT-O from baseline to about 3-months post surgery
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The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.
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Change in FACT-O from baseline to about 3-months post surgery
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Study Feasibility - Participant Accrual
Time Frame: Throughout study completion, about 2 years
|
Participant accrual calculated as % of patients referred divided by number of patients consented to participation
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Throughout study completion, about 2 years
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Study Feasibility - Participant Attrition
Time Frame: Through study completion, about 2 years
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Participant attrition calculated as % of consented patients who complete a minimum of 4 weeks of pre-surgical exercise divided by number who withdraw
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Through study completion, about 2 years
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Study Feasibility - Participant Adherence
Time Frame: Throughout study completion, about 2 years
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Participant program adherence calculated as % of minimum number of exercise sessions completed (e.g., 3 sessions/week for a minimum of 4 weeks for a total of 12 sessions) divided by total number of available exercise sessions over 12-week intervention
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Throughout study completion, about 2 years
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Adverse Events
Time Frame: Throughout study completion, about 2 years
|
All exercise-related adverse and serious adverse will be recorded
|
Throughout study completion, about 2 years
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Scott Grandy, PhD, Nova Scotia Health
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Frailty
- Ovarian Neoplasms
- Motor Activity
Other Study ID Numbers
Other Study ID Numbers
- NSH Adv Ovarian Cancer Prehab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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