Prehabilitation for Ovarian Cancer Patients

The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer; Frailty; Exercise; Enhanced Recovery After Surgery; Surgical Complication; Prehabilitation; Treatment Outcomes
• Intervention / Treatment: Behavioral: Prehabilitation Exercise Intervention

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Grandy, PhD; Phone Number: 902-494-1145; Email: grandy@dal.ca

Study Locations

• Canada
  • Nova Scotia
    • 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

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Circuit-based prehabilitation exercise intervention

Behavioral: Prehabilitation Exercise Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline to end of 4+ week intervention (pre-surgery)
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.	Change from baseline to about 1-month post-surgery
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.	Change from baseline to about 3-month post-surgery
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).	Surgical complexity will be assessed about 1-month post-surgery.
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.	Post-surgical outcomes will be assessed about 1-month post-surgery.
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.	Surgical complications will be assessed post-surgery about 1-month post-surgery.
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	At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.
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	At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.
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	At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.
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	At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.
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	At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.
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	At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index Change (baseline to post exercise intervention)	Weight (kg) and height (m) will be used to calculate BMI	Change in BMI from baseline to post 4+ week exercise intervention
Body Mass Index Change (baseline to 1-month post surgery)	Weight (kg) and height (m) will be used to calculate BMI	Change in BMI from baseline to about 1-month post surgery.
Body Mass Index Change (baseline to 3-months post surgery)	Weight (kg) and height (m) will be used to calculate BMI	Change in BMI from baseline to about 3-month post surgery.
Aerobic Fitness Change (baseline to post exercise intervention)	The six-minute walk will be used to calculate aerobic fitness	Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)
Aerobic Fitness Change (baseline to 1-month post surgery)	The six-minute walk will be used to calculate aerobic fitness	Change in aerobic fitness from baseline to about 1-month post surgery
Aerobic Fitness Change (baseline to 3-months post surgery)	The six-minute walk will be used to calculate aerobic fitness	Change in aerobic fitness from baseline to about 3-months post surgery
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.	Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery)
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.	Change in muscular fitness will be assessed from baseline to 1-month post surgery.
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.	Change in muscular fitness will be assessed from baseline to 3-months post surgery.
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	Chang in health-related quality of life from baseline to post 4+ week intervention (pre-surgery)
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	Chang in health-related quality of life from baseline to about 1-month post surgery
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	Change in health-related quality of life from baseline to about 3-months post surgery
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.	Change in FACT-O from baseline to post 4+ week intervention (pre-surgery)
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.	Change in FACT-O from baseline to about 1-month post surgery
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.	Change in FACT-O from baseline to about 3-months post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Feasibility - Participant Accrual	Participant accrual calculated as % of patients referred divided by number of patients consented to participation	Throughout study completion, about 2 years
Study Feasibility - Participant Attrition	Participant attrition calculated as % of consented patients who complete a minimum of 4 weeks of pre-surgical exercise divided by number who withdraw	Through study completion, about 2 years
Study Feasibility - Participant Adherence	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	Throughout study completion, about 2 years
Adverse Events	All exercise-related adverse and serious adverse will be recorded	Throughout study completion, about 2 years

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Dalhousie University
• Investigators: Principal Investigator: Scott Grandy, PhD, Nova Scotia Health

Publications and helpful links

Helpful Links

• Laboratory website

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

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: NSH Adv Ovarian Cancer Prehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No