The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Frailty Change (baseline to post exercise intervention)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Intervention
Circuit-based prehabilitation exercise intervention
Intervention: Prehabilitation Exercise Intervention (Behavioral)
Outcomes
Primary Outcomes
Frailty Change (baseline to post exercise intervention)
Time Frame: Change from baseline to end of 4+ week intervention (pre-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 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.
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.
Surgical Complexity Score (1-month post surgery)
Time Frame: Surgical complexity will be assessed about 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)
Time Frame: Post-surgical outcomes will be assessed about 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.
Chemotherapy completion rates (End of Cycle 1)
Time Frame: At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Surgical Complications (1-month post surgery)
Time Frame: Surgical complications will be assessed post-surgery about 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 2)
Time Frame: At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.
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)
Time Frame: At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.
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)
Time Frame: At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.
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)
Time Frame: At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.
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)
Time Frame: At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.
Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment
Secondary Outcomes
- Body Mass Index Change (baseline to 1-month post surgery)(Change in BMI from baseline to about 1-month post surgery.)
- Health-Related Quality of Life Change (baseline to post exercise intervention(Chang in health-related quality of life 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)(Change in FACT-O from baseline to about 1-month post surgery)
- Body Mass Index Change (baseline to post exercise intervention)(Change in BMI from baseline to post 4+ week exercise intervention)
- Muscular Fitness Change (baseline to post exercise intervention)(Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery))
- Health-Related Quality of Life Change (baseline to 1-month post surgery)(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)(Change in health-related quality of life from baseline to about 3-months post surgery)
- Body Mass Index Change (baseline to 3-months post surgery)(Change in BMI from baseline to about 3-month post surgery.)
- Aerobic Fitness Change (baseline to post exercise intervention)(Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery))
- Aerobic Fitness Change (baseline to 1-month post surgery)(Change in aerobic fitness from baseline to about 1-month post surgery)
- Aerobic Fitness Change (baseline to 3-months post surgery)(Change in aerobic fitness from baseline to about 3-months post surgery)
- Muscular Fitness Change (baseline to about 1-month post surgery)(Change in muscular fitness will be assessed from baseline to 1-month post surgery.)
- Muscular Fitness Change (baseline to about 3-months post surgery)(Change in muscular fitness will be assessed from baseline to 3-months post surgery.)
- Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)(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 3-months post surgery)(Change in FACT-O from baseline to about 3-months post surgery)