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Prehabilitation for Ovarian Cancer Patients

Primary Purpose

Prehabilitation, Exercise, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prehabilitation Exercise Intervention
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Nova Scotia HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Circuit-based prehabilitation exercise intervention

Outcomes

Primary Outcome Measures

Frailty Change (baseline to post exercise intervention)
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.
Frailty Change (baseline to 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.
Frailty Change (baseline to 3-months 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.
Surgical Complexity Score (1-month post surgery)
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).
Post-Surgical Outcomes (1-month post surgery)
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.
Surgical Complications (1-month post surgery)
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.
Chemotherapy completion rates (End of Cycle 1)
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Chemotherapy completion rates (End of Cycle 2)
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Chemotherapy completion rates (End of Cycle 3)
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Chemotherapy completion rates (End of Cycle 4)
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Chemotherapy completion rates (End of Cycle 5)
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Chemotherapy completion rates (End of Cycle 6)
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

Secondary Outcome Measures

Body Mass Index Change (baseline to post exercise intervention)
Weight (kg) and height (m) will be used to calculate BMI
Body Mass Index Change (baseline to 1-month post surgery)
Weight (kg) and height (m) will be used to calculate BMI
Body Mass Index Change (baseline to 3-months post surgery)
Weight (kg) and height (m) will be used to calculate BMI
Aerobic Fitness Change (baseline to post exercise intervention)
The six-minute walk will be used to calculate aerobic fitness
Aerobic Fitness Change (baseline to 1-month post surgery)
The six-minute walk will be used to calculate aerobic fitness
Aerobic Fitness Change (baseline to 3-months post surgery)
The six-minute walk will be used to calculate aerobic fitness
Muscular Fitness Change (baseline to post exercise intervention)
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.
Muscular Fitness Change (baseline to about 1-month post surgery)
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.
Muscular Fitness Change (baseline to about 3-months post surgery)
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.
Health-Related Quality of Life Change (baseline to post exercise intervention
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
Health-Related Quality of Life Change (baseline to 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
Health-Related Quality of Life Change (baseline to 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
Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)
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.
Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 1-month post surgery)
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.
Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 3-months post surgery)
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.

Full Information

First Posted
March 30, 2022
Last Updated
February 6, 2023
Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University
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1. Study Identification

Unique Protocol Identification Number
NCT05364879
Brief Title
Prehabilitation for Ovarian Cancer Patients
Official Title
The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Dalhousie University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehabilitation, Exercise, Frailty, Ovarian Cancer, Surgical Complication, Treatment Outcomes, Enhanced Recovery After Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Circuit-based prehabilitation exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
Prehabilitation Exercise Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frailty Change (baseline to post exercise intervention)
Description
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.
Time Frame
Change from baseline to end of 4+ week intervention (pre-surgery)
Title
Frailty Change (baseline to 1-month post surgery)
Description
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.
Time Frame
Change from baseline to about 1-month post-surgery
Title
Frailty Change (baseline to 3-months post surgery)
Description
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.
Time Frame
Change from baseline to about 3-month post-surgery
Title
Surgical Complexity Score (1-month post surgery)
Description
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).
Time Frame
Surgical complexity will be assessed about 1-month post-surgery.
Title
Post-Surgical Outcomes (1-month post surgery)
Description
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.
Time Frame
Post-surgical outcomes will be assessed about 1-month post-surgery.
Title
Surgical Complications (1-month post surgery)
Description
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.
Time Frame
Surgical complications will be assessed post-surgery about 1-month post-surgery.
Title
Chemotherapy completion rates (End of Cycle 1)
Description
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Time Frame
At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.
Title
Chemotherapy completion rates (End of Cycle 2)
Description
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Time Frame
At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.
Title
Chemotherapy completion rates (End of Cycle 3)
Description
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Time Frame
At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.
Title
Chemotherapy completion rates (End of Cycle 4)
Description
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Time Frame
At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.
Title
Chemotherapy completion rates (End of Cycle 5)
Description
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Time Frame
At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.
Title
Chemotherapy completion rates (End of Cycle 6)
Description
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Time Frame
At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.
Secondary Outcome Measure Information:
Title
Body Mass Index Change (baseline to post exercise intervention)
Description
Weight (kg) and height (m) will be used to calculate BMI
Time Frame
Change in BMI from baseline to post 4+ week exercise intervention
Title
Body Mass Index Change (baseline to 1-month post surgery)
Description
Weight (kg) and height (m) will be used to calculate BMI
Time Frame
Change in BMI from baseline to about 1-month post surgery.
Title
Body Mass Index Change (baseline to 3-months post surgery)
Description
Weight (kg) and height (m) will be used to calculate BMI
Time Frame
Change in BMI from baseline to about 3-month post surgery.
Title
Aerobic Fitness Change (baseline to post exercise intervention)
Description
The six-minute walk will be used to calculate aerobic fitness
Time Frame
Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)
Title
Aerobic Fitness Change (baseline to 1-month post surgery)
Description
The six-minute walk will be used to calculate aerobic fitness
Time Frame
Change in aerobic fitness from baseline to about 1-month post surgery
Title
Aerobic Fitness Change (baseline to 3-months post surgery)
Description
The six-minute walk will be used to calculate aerobic fitness
Time Frame
Change in aerobic fitness from baseline to about 3-months post surgery
Title
Muscular Fitness Change (baseline to post exercise intervention)
Description
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.
Time Frame
Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery)
Title
Muscular Fitness Change (baseline to about 1-month post surgery)
Description
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.
Time Frame
Change in muscular fitness will be assessed from baseline to 1-month post surgery.
Title
Muscular Fitness Change (baseline to about 3-months post surgery)
Description
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.
Time Frame
Change in muscular fitness will be assessed from baseline to 3-months post surgery.
Title
Health-Related Quality of Life Change (baseline to post exercise intervention
Description
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
Time Frame
Chang in health-related quality of life from baseline to post 4+ week intervention (pre-surgery)
Title
Health-Related Quality of Life Change (baseline to 1-month post surgery)
Description
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
Time Frame
Chang in health-related quality of life from baseline to about 1-month post surgery
Title
Health-Related Quality of Life Change (baseline to 3-months post surgery)
Description
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
Time Frame
Change in health-related quality of life from baseline to about 3-months post surgery
Title
Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)
Description
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.
Time Frame
Change in FACT-O from baseline to post 4+ week intervention (pre-surgery)
Title
Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 1-month post surgery)
Description
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.
Time Frame
Change in FACT-O from baseline to about 1-month post surgery
Title
Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 3-months post surgery)
Description
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.
Time Frame
Change in FACT-O from baseline to about 3-months post surgery
Other Pre-specified Outcome Measures:
Title
Study Feasibility - Participant Accrual
Description
Participant accrual calculated as % of patients referred divided by number of patients consented to participation
Time Frame
Throughout study completion, about 2 years
Title
Study Feasibility - Participant Attrition
Description
Participant attrition calculated as % of consented patients who complete a minimum of 4 weeks of pre-surgical exercise divided by number who withdraw
Time Frame
Through study completion, about 2 years
Title
Study Feasibility - Participant Adherence
Description
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
Time Frame
Throughout study completion, about 2 years
Title
Adverse Events
Description
All exercise-related adverse and serious adverse will be recorded
Time Frame
Throughout study completion, about 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Grandy, PhD
Phone
902-494-1145
Email
grandy@dal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Grandy, PhD
Organizational Affiliation
Nova Scotia Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Scotia Health
City
Halifax
State/Province
Nova Scotia (NS)
ZIP/Postal Code
B3L 4P1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Grandy, MD
Phone
902-494-4303
Email
scott.grandy@dal.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.thepaclab.com
Description
Laboratory website

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Prehabilitation for Ovarian Cancer Patients

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