Prehabilitation for Ovarian Cancer Patients

Official title

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

Overview

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.

Interventions

• 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 begi

Primary outcome measures

• Frailty Change (baseline to post exercise intervention) [Time frame: Change from baseline to end of 4+ week intervention (pre-surgery)]
• Frailty Change (baseline to 1-month post surgery) [Time frame: Change from baseline to about 1-month post-surgery]
• Frailty Change (baseline to 3-months post surgery) [Time frame: Change from baseline to about 3-month post-surgery]
• Surgical Complexity Score (1-month post surgery) [Time frame: Surgical complexity will be assessed about 1-month post-surgery.]
• Post-Surgical Outcomes (1-month post surgery) [Time frame: Post-surgical outcomes will be assessed about 1-month post-surgery.]
• Surgical Complications (1-month post surgery) [Time frame: Surgical complications will be assessed post-surgery about 1-month post-surgery.]
• 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 (End of Cycle 2) [Time frame: At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.]
• 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 (End of Cycle 4) [Time frame: At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.]

Secondary outcome measures (12)

• Body Mass Index Change (baseline to post exercise intervention) [Time frame: Change in BMI from baseline to post 4+ week exercise intervention]
• Body Mass Index Change (baseline to 1-month post surgery) [Time frame: Change in BMI from baseline to about 1-month post surgery.]
• Body Mass Index Change (baseline to 3-months post surgery) [Time frame: Change in BMI from baseline to about 3-month post surgery.]
• Aerobic Fitness Change (baseline to post exercise intervention) [Time frame: Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)]
• Aerobic Fitness Change (baseline to 1-month post surgery) [Time frame: Change in aerobic fitness from baseline to about 1-month post surgery]
• Aerobic Fitness Change (baseline to 3-months post surgery) [Time frame: Change in aerobic fitness from baseline to about 3-months post surgery]
• 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)]
• 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.]
• 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.]
• 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)]
• 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 Change (baseline to 3-months post surgery) [Time frame: Change in health-related quality of life from baseline to about 3-months post surgery]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Canada · 1 center

• Nova Scotia Health — Halifax

Identifiers

NCT: NCT05364879 · NSH Adv Ovarian Cancer Prehab

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗