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
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
Treatment Details
Interventions
- FIT4SURGERY (Behavioral Intervention)
- Healthy Lifestyle Control (Behavioral Intervention)
Trial OverviewThe 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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Trials
1,674
Recruited
989,000+
Dr. Jeffrey Sherman
Northwestern University
Chief Medical Officer
MD from Northwestern University
Dr. Alicia Löffler
Northwestern University
Chief Executive Officer since 2010
PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech