Prehabilitation for Ovarian Cancer

(FIT4SURGERY Trial)

Overseen By Anne Grace, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Uncontrolled cardiovascular disease, non-ambulatory, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test the effectiveness of a home-based, patient-tailored intervention, FIT4SURGERY, to promote physical activity among women with ovarian cancer undergoing neoadjuvant chemotherapy.

Research Team

Emma Barber

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for women over 60 with ovarian, fallopian tube, or primary peritoneal cancer who are about to start neoadjuvant chemotherapy and have surgery planned. Participants must speak English, own a smartphone, and have internet access. It's not for pregnant women, prisoners, those without oncologist clearance, patients on chemo only, or those with severe heart disease or cognitive/functional limitations.

Inclusion Criteria

Have access to the internet to complete assessments

I am diagnosed with ovarian, fallopian tube, or peritoneal cancer and will have chemotherapy and surgery.

Own a smartphone

Exclusion Criteria

I do not have severe heart issues, mobility problems, or major cognitive/functional limitations.

Pregnant women or prisoners

I am scheduled for chemotherapy treatment only.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a home-based, patient-tailored physical activity intervention using the Fit4Surgery program, including a FitBit device, mobile app, and weekly coaching calls.

9-12 weeks

Weekly check-in calls

Neoadjuvant Chemotherapy

Participants receive 3-4 cycles of neoadjuvant chemotherapy prior to surgery.

12-16 weeks

Surgery

Participants undergo cytoreductive surgery for ovarian cancer.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of surgical complications and progression-free survival.

90 days post-surgery

Long-term Follow-up

Medical records are reviewed for up to three years to monitor for cancer recurrence and overall survival.

3 years

Treatment Details

Interventions

• FIT4SURGERY
• Healthy Lifestyle Control

Trial Overview The study tests FIT4SURGERY—a home-based program designed to increase physical activity in older women during the time between starting chemotherapy and having surgery for ovarian cancer—against a healthy lifestyle control group.

Participant Groups

Group I: FIT4SURGERY Intervention Experimental Treatment 1 Intervention

The Fit4Surgery intervention consists of the FitBit Inspire HR device, the Fit4Surgery mobile app, and weekly coaching calls.

Group II: Healthy Lifestyle Control Active Control 1 Intervention

The Healthy Lifestyle Control group engages in their usual activities and receives education about physical activity and a healthy lifestyle for ovarian cancer patients. They receive weekly check in calls.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+