Physical Activity Monitored by Fitbit Charge 2 in Improving Quality of Life in Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Completed · Phase 2

Conditions studied: Fallopian Tube Endometrioid Tumor, Fallopian Tube Mucinous Neoplasm, Fallopian Tube Serous Neoplasm, Ovarian Clear Cell Tumor, Ovarian Endometrioid Tumor, Ovarian Mucinous Tumor, Ovarian Serous Tumor, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

In brief

This phase II trial studies how well physical activity monitored by Fitbit Charge 2 works in improving quality of life in participants with ovarian, primary peritoneal, or fallopian tube cancer that has come back. A modern, state of the art activity tracking device (Fitbit Charge 2) may help to measure physical activity, heart rate, and sleep pattern, and may help doctors to learn whether physical activity level has any relationship to energy level, sleep duration and quality, toxicity from chemotherapy, immune cells in blood, and bacterial composition in gut.

Key facts

Study ID

NCT03685695

Run by

Roswell Park Cancer Institute

People needed

9

Starts

2017-06-27

Expected to finish

2020-07-30

Last updated by the study team

2021-09-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1
• Have recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer (serous, clear cell, endometrioid or mucinous)
• Patient is willing to wear activity tracking device at least 70% of the time for the duration of the study (9 months)
• Patient is getting cancer treatment and surveillance visit at Roswell Park Cancer Institute during the study period
• Patient is willing to participate in quality of life (QOL) questionnaires and blood and stool collection throughout the study for translational research purposes
• Has no risk factors for increased risk for exercise related complications assessed by 2017 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) questionnaire and principal investigator (PI)/cooperative (Co)-PI
• If positive screening test on 2017 PAR-Q+ questionnaire, medical clearance need to be documented by PI/Co-PI with doctor of medicine (MD) degree and/or primary care physician or cardiologist, if deemed necessary by the PI/Co-PIs prior to starting increased physical activity (PA) portion of the trial

You may not qualify if…

• Patient with serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization in the previous 12 months)
• Patients with a life expectancy of less than 6 months
• Patients may not have any other active malignancy that currently requires treatment with the exception of non-melanoma skin cancer
• Unwilling or unable to follow protocol requirements

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.