30 Participants Needed

Prehabilitation for Ovarian Cancer

(FIT4SURGERY Trial)

EB
AG
Overseen ByAnne Grace, PhD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Northwestern University
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Emma Barber, MD: Robert H. Lurie ...

Emma Barber

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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
See 2 more

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: FIT4SURGERY InterventionExperimental Treatment1 Intervention
Group II: Healthy Lifestyle ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+
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