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
|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
|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|
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
Device: Monitoring Device
Wear Fitbit Charge 2
Other Name: Monitor
Other: Physical Activity
Complete aimed walking steps
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- 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.
- 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.
- 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.
- 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.
- 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,
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
|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|
|Principal Investigator:||Emese Zsiros||Roswell Park Cancer Institute|