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

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ClinicalTrials.gov Identifier: NCT03685695
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Other: Laboratory Biomarker Analysis Device: Monitoring Device Other: Physical Activity Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Life on the Go 2: Evaluating the Effect of Physical Activity of Patients With Recurrent Ovarian Cancer Using State of the Art Activity Tracking Device
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : June 13, 2020
Estimated Study Completion Date : June 12, 2021


Arm Intervention/treatment
Experimental: Supportive care (physical activity)
Participants wear Fitbit Charge 2 to monitor physical activity for 3 courses (9-12 weeks). Participants then increase their activity minutes to 30 minutes, 5 times a week or by 30% for 6 additional months.
Other: Laboratory Biomarker Analysis
Correlative studies

Device: Monitoring Device
Wear Fitbit Charge 2
Other Name: Monitor

Other: Physical Activity
Complete aimed walking steps

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Number of participants who wear and track g data using the Fitbit Charge 2 activity wrist band [ Time Frame: Up to 3 years ]
    If observed compliance rate is 70% , use of the device will be deemed feasible.

  2. Persuasive effect of using the Fitbit Charge 2 on physical activity (PA) [ Time Frame: Up to 3 years ]
    Will be assessed by comparing average daily PA measurements (described above) between pre- and post-counseling, using two-sided t-tests.


Secondary Outcome Measures :
  1. Change in Quality of Life Questionnaire scores [ Time Frame: Up to 3 years ]
    The EORTC QLQ-30 will assess perception of the quality of LIfe in cancer patients.

  2. Daily steps [ Time Frame: Up to 3 years ]
    daily steps recorded by the activity device will be averaged over the time periods between patient visits, with days of zero daily steps excluded from the average.

  3. Heart Rate [ Time Frame: Up to 3 years ]
    The heart rate recorded by the activity device will be averaged over the time periods between patient visits,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685695


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Emese Zsiros    716-845-8337    Emese.Zsiros@RoswellPark.org   
Principal Investigator: Emese Zsiros         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Emese Zsiros Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03685695     History of Changes
Other Study ID Numbers: I 45817
NCI-2018-00343 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 45817 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases