Clinical trial NCT05364879: Prehabilitation for Ovarian Cancer Patients
Official title: The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Exercise
Frailty
Ovarian Cancer
Surgical Complication
Treatment Outcomes
Enhanced Recovery After Surgery
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2022-05-06
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Frailty Change (baseline to post exercise intervention)
timeFrame: Change from baseline to end of 4+ week intervention (pre-surgery)
measure: Frailty Change (baseline to 1-month post surgery)
timeFrame: Change from baseline to about 1-month post-surgery
measure: Frailty Change (baseline to 3-months post surgery)
timeFrame: Change from baseline to about 3-month post-surgery
measure: Surgical Complexity Score (1-month post surgery)
timeFrame: Surgical complexity will be assessed about 1-month post-surgery.
measure: Post-Surgical Outcomes (1-month post surgery)
timeFrame: Post-surgical outcomes will be assessed about 1-month post-surgery.
measure: Surgical Complications (1-month post surgery)
timeFrame: Surgical complications will be assessed post-surgery about 1-month post-surgery.
measure: Chemotherapy completion rates (End of Cycle 1)
timeFrame: At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.
measure: Chemotherapy completion rates (End of Cycle 2)
timeFrame: At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.
measure: Chemotherapy completion rates (End of Cycle 3)
timeFrame: At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.
measure: Chemotherapy completion rates (End of Cycle 4)
timeFrame: At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.
measure: Chemotherapy completion rates (End of Cycle 5)
timeFrame: At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.
measure: Chemotherapy completion rates (End of Cycle 6)
timeFrame: At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.
Secondary outcomes:
measure: Body Mass Index Change (baseline to post exercise intervention)
timeFrame: Change in BMI from baseline to post 4+ week exercise intervention
measure: Body Mass Index Change (baseline to 1-month post surgery)
timeFrame: Change in BMI from baseline to about 1-month post surgery.
measure: Body Mass Index Change (baseline to 3-months post surgery)
timeFrame: Change in BMI from baseline to about 3-month post surgery.
measure: Aerobic Fitness Change (baseline to post exercise intervention)
timeFrame: Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)
measure: Aerobic Fitness Change (baseline to 1-month post surgery)
timeFrame: Change in aerobic fitness from baseline to about 1-month post surgery
measure: Aerobic Fitness Change (baseline to 3-months post surgery)
timeFrame: Change in aerobic fitness from baseline to about 3-months post surgery
measure: Muscular Fitness Change (baseline to post exercise intervention)
timeFrame: Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery)
measure: Muscular Fitness Change (baseline to about 1-month post surgery)
timeFrame: Change in muscular fitness will be assessed from baseline to 1-month post surgery.
measure: Muscular Fitness Change (baseline to about 3-months post surgery)
timeFrame: Change in muscular fitness will be assessed from baseline to 3-months post surgery.
measure: Health-Related Quality of Life Change (baseline to post exercise intervention
timeFrame: Chang in health-related quality of life from baseline to post 4+ week intervention (pre-surgery)
measure: Health-Related Quality of Life Change (baseline to 1-month post surgery)
timeFrame: Chang in health-related quality of life from baseline to about 1-month post surgery
measure: Health-Related Quality of Life Change (baseline to 3-months post surgery)
timeFrame: Change in health-related quality of life from baseline to about 3-months post surgery
measure: Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)
timeFrame: Change in FACT-O from baseline to post 4+ week intervention (pre-surgery)
measure: Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 1-month post surgery)
timeFrame: Change in FACT-O from baseline to about 1-month post surgery
measure: Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 3-months post surgery)
timeFrame: Change in FACT-O from baseline to about 3-months post surgery
Other outcomes:
measure: Study Feasibility - Participant Accrual
timeFrame: Throughout study completion, about 2 years
measure: Study Feasibility - Participant Attrition
timeFrame: Through study completion, about 2 years
measure: Study Feasibility - Participant Adherence
timeFrame: Throughout study completion, about 2 years
measure: Adverse Events
timeFrame: Throughout study completion, about 2 years
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health
name: Scott Grandy, PhD
role: PRINCIPAL_INVESTIGATOR
References: