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NCT Number: NCT05364879

Prehabilitation for 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.

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Key information

Conditions

Prehabilitation Adnexal Diseases Behavior Endocrine Gland Neoplasms Endocrine System Diseases Enhanced Recovery After Surgery Exercise Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Motor Activity Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Complication Treatment Outcomes Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nova Scotia Health

Halifax, Nova Scotia, B3L 4P1, Canada

Location status: Recruiting

Location contact

Scott Grandy, MD

CONTACT

[email protected]

902-494-4303

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prehabilitation Exercise Intervention

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  1. Body Mass Index Change (baseline to post exercise intervention)

    Time frame: Change in BMI from baseline to post 4+ week exercise intervention

    Weight (kg) and height (m) will be used to calculate BMI

  2. Body Mass Index Change (baseline to 1-month post surgery)

    Time frame: Change in BMI from baseline to about 1-month post surgery.

    Weight (kg) and height (m) will be used to calculate BMI

  3. Body Mass Index Change (baseline to 3-months post surgery)

    Time frame: Change in BMI from baseline to about 3-month post surgery.

    Weight (kg) and height (m) will be used to calculate BMI

  4. Aerobic Fitness Change (baseline to post exercise intervention)

    Time frame: Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)

    The six-minute walk will be used to calculate aerobic fitness

  5. Aerobic Fitness Change (baseline to 1-month post surgery)

    Time frame: Change in aerobic fitness from baseline to about 1-month post surgery

    The six-minute walk will be used to calculate aerobic fitness

  6. Aerobic Fitness Change (baseline to 3-months post surgery)

    Time frame: Change in aerobic fitness from baseline to about 3-months post surgery

    The six-minute walk will be used to calculate aerobic fitness

  7. 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 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.

  8. 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 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.

  9. 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.

    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.

  10. 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 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

  11. 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 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

  12. 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

    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

  13. Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)

    Time frame: Change in FACT-O from baseline to post 4+ week intervention (pre-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.

  14. Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 1-month post surgery)

    Time frame: Change in FACT-O from baseline to about 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.

  15. Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 3-months post surgery)

    Time frame: Change in FACT-O from baseline to about 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.

Other outcomes

  1. Study Feasibility - Participant Accrual

    Time frame: Throughout study completion, about 2 years

    Participant accrual calculated as % of patients referred divided by number of patients consented to participation

  2. Study Feasibility - Participant Attrition

    Time frame: Through study completion, about 2 years

    Participant attrition calculated as % of consented patients who complete a minimum of 4 weeks of pre-surgical exercise divided by number who withdraw

  3. Study Feasibility - Participant Adherence

    Time frame: Throughout study completion, about 2 years

    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

  4. Adverse Events

    Time frame: Throughout study completion, about 2 years

    All exercise-related adverse and serious adverse will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Scott Grandy, PhD

CONTACT

[email protected]

902-494-1145

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Dalhousie University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 6, 2022
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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