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Prehabilitation for Ovarian Cancer (FIT4SURGERY Trial)

N/A

Recruiting

Led By Emma Barber, MD, MS

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with ovarian, fallopian tube or primary peritoneal cancer and undergoing planned neoadjuvant chemotherapy and are expecting to undergo planned surgery

Female; ≥ 60 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three years post surgery

Awards & highlights

FIT4SURGERY Trial Summary

This trial will test a home-based physical activity intervention for women with ovarian cancer undergoing neoadjuvant chemotherapy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention focuses on promoting physical activity rather than medication or medical procedures, side effects may include typical exercise-related issues such as muscle soreness or fatigue but will vary based on individual health conditions.

FIT4SURGERY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I am a woman aged 60 or older.

FIT4SURGERY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three years post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three years post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and three years post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients who are adherent to the Fit4Surgery intervention measured among those in the Fit4Surgery arm.

Proportion of patients who are evaluable for both baseline and post-intervention assessments

Secondary outcome measures

Adverse Events

Change in anxiety

Change in fatigue

+5 more

FIT4SURGERY Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FIT4SURGERY InterventionExperimental Treatment1 Intervention

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

Group II: Healthy Lifestyle ControlActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,201 Total Patients Enrolled

10 Trials studying Ovarian Cancer

6,369 Patients Enrolled for Ovarian Cancer

Emma Barber, MD, MSPrincipal InvestigatorNorthwestern University

3 Previous Clinical Trials

294 Total Patients Enrolled

2 Trials studying Ovarian Cancer

267 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the foremost aims of this clinical trial?

"The intended primary outcome of this clinical trial, which will be assessed over a period of between 9 to 12 weeks, is the adherence rate of participants in the Fit4Surgery group. Secondary outcomes are changes in patient frailty as defined by Fried's Phenotype Method and physical function measured through PROMIS Physical Function Short Form 10a , along with overall survival monitored up to 3 years post-treatment."

Answered by AI

Is it currently possible to enroll in the clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov stipulates that this medical experiment, which was originally advertised on December 10th 2021, is actively recruiting. Approximately 30 patients need to be enrolled from a single site."

Answered by AI

How many individuals are participants of this clinical experiment?

"Affirmative. The information accessible on clinicaltrials.gov affirms that this medical trial, which was initially published on December 10th 2021, is currently enrolling participants. Thirty patients must be recruited from 1 specific location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer

Emma Barber 2021. "Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05092763.