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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called FIT4SURGERY to determine if it helps women with ovarian cancer remain active during chemotherapy. The goal is to assess whether a home-based plan, which includes a Fitbit, a special app, and weekly coaching calls, can enhance physical activity levels. Participants will be compared to a group receiving general health advice and weekly check-ins. Women diagnosed with ovarian cancer who are preparing for chemotherapy and surgery may be suitable candidates, especially if they have a smartphone and internet access. As an unphased trial, this study provides an opportunity to contribute to innovative research that could improve quality of life during treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FIT4SURGERY intervention is safe for ovarian cancer patients?

Previous studies found the FIT4SURGERY program to be safe. This program includes a FitBit device, a mobile app, and weekly coaching, and participants responded positively. Research showed that most people remained engaged with the program. No serious side effects were reported. Instead, participants increased their daily steps and improved their quality of life. The program also reduced post-surgery complications for some cancer patients. Overall, FIT4SURGERY appears to be a safe and effective way to boost physical activity for women with ovarian cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FIT4SURGERY protocol because it introduces a holistic approach to preparing ovarian cancer patients for surgery. Unlike standard care options that focus primarily on chemotherapy and surgery, FIT4SURGERY incorporates technology and lifestyle changes. This program uses the FitBit Inspire HR device and a mobile app to track physical activity, paired with weekly coaching calls to encourage a healthier lifestyle. The goal is to improve physical fitness and overall well-being before surgery, potentially leading to better surgical outcomes and recovery.

What evidence suggests that the FIT4SURGERY intervention is effective for promoting physical activity in women with ovarian cancer?

Research has shown that the FIT4SURGERY program, an intervention in this trial for women with ovarian cancer, may help increase physical activity. Studies found that patients using this program walked more each day, indicating increased activity levels. Early results also suggest that patients felt better about their physical health. The program is home-based and personalized for each patient, using a FitBit device, a mobile app, and regular coaching calls. This setup encourages participants to stay engaged and adhere to the program, which is a positive sign for its effectiveness. Meanwhile, participants in the Healthy Lifestyle Control group engage in their usual activities and receive education about physical activity and a healthy lifestyle for ovarian cancer patients, along with weekly check-in calls. ^{1 2 6 7 8}

Who Is on the Research Team?

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

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 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?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40616957/

Fit4Surgery: A pilot randomized controlled trial to assess the ... Fit4Surgery was feasible with high engagement and adherence. Patients demonstrated increased daily step count and positive trends in PROs, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825008960

Fit4Surgery: A pilot randomized controlled trial to assess ... Fit4Surgery (F4S) is a novel, patient-tailored, home-based prehabilitation program for patients with ovarian cancer.

3. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(25)00896-0/abstract

Fit4Surgery: A pilot randomized controlled trial to assess ... Fit4Surgery (F4S) is a novel, patient-tailored, home-based prehabilitation program for patients with ovarian cancer.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-02061

Prehabilitation Program (Fit4Surgery) in Older Women with ... The purpose of this trial is to test the effectiveness of a home-based, patient-tailored intervention, Fit4Surgery, to promote physical activity among women ...

5. youtube.com youtube.com/watch?v=RJS1cAJKejY

Fit4Surgery Study Aims to Improve Surgical Outcomes for ... Emma L. Barber, MD, presents her Fit4Surgery study, which aims to improve the physical performance and fitness of patients over 60 with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11226070/

Multimodal prehabilitation (Fit4Surgery) in high-impact ... The primary outcomes of this study will be the occurrence and severity of postoperative complications, as measured by the Clavien-Dindo ...

7. researchgate.net researchgate.net/publication/393449301_Fit4Surgery_A_pilot_randomized_controlled_trial_to_assess_the_feasibility_of_prehabilitation_prior_to_debulking_surgery_for_ovarian_cancer

A pilot randomized controlled trial to assess the feasibility ... Fit4Surgery: A pilot randomized controlled trial to assess the feasibility of prehabilitation prior to debulking surgery for ovarian cancer.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0303829

Multimodal prehabilitation (Fit4Surgery) in high-impact ... Multimodal prehabilitation has demonstrated a reduction in postoperative complications and enhanced functional recovery, mainly in abdominal cancer surgery.