Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-06-16 @ 8:33 PM
Study NCT ID:
NCT03685695
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Monitored by Fitbit Charge 2 in Improving Quality of Life in Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To demonstrate feasibility of wearing (at least 70% of the time) and tracking data (daily physical activity, heart rate, sleep pattern) using a Fitbit Charge 2 activity wrist band (or any comparable activity wristband that the patient may already use and is capable of the same functions, such as Fitbit Charge HR, Fitbit Surge or Fitbit Blaze) in 30 patients with recurrent ovarian cancer who are progressing on treatment and starting first cycle of a new regimen for a total of 9 months.
II. To demonstrate feasibility of using persuasive fitness technologies to increase physical activity by 30 % from baseline and to increase patients? active minutes to 30 minutes, five times a week, or by 30% if patient is meeting that goal already, for 6 months period of time.
SECONDARY OBJECTIVES:
I. To assess how patient?s physical activity level, without providing specific counseling or exercise regimen, compares to American Heart Association (AHA)?s recommendation and to the target of 10,000 steps promoted by various activity tracking devices.
II. To determine whether patients? perception on quality of life, physical activity and energy level assessed by questionnaires: Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Goldin Leisure-Time Exercise Questionnaire and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 and Ovarian Cancer (OV)28 correlates with activity tracked by the device.
III. To assess the association between subjectively measured sleep duration/quality (using the Pittsburgh Sleep Quality Scale), compared to sleeping pattern tracked by the activity device.
IV. To determine whether increased physical activity correlates with less chemotherapy related toxicity in the ovarian cancer patient population (any Common Terminology Criteria for Adverse Events \[CTCAE\] version 4, grade 3 or 4 toxicity).
EXPLORATORY OBJECTIVES:
I. To assess whether persistent increase of heart rate could predict adverse events related to surgery or adjuvant treatment.
II. To examine if the change in level of inflammatory biomarkers and T cell subsets in circulation correlates with increased physical activity.
III. To examine the immunoscore on tumor specimens and whether it correlates with level of physical activity.
IV. To examine the composition and diversity of gut microbiome in correlation with physical activity level.
OUTLINE:
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.
After completion of study, participants are followed up for up to 3 years.
I. To demonstrate feasibility of wearing (at least 70% of the time) and tracking data (daily physical activity, heart rate, sleep pattern) using a Fitbit Charge 2 activity wrist band (or any comparable activity wristband that the patient may already use and is capable of the same functions, such as Fitbit Charge HR, Fitbit Surge or Fitbit Blaze) in 30 patients with recurrent ovarian cancer who are progressing on treatment and starting first cycle of a new regimen for a total of 9 months.
II. To demonstrate feasibility of using persuasive fitness technologies to increase physical activity by 30 % from baseline and to increase patients? active minutes to 30 minutes, five times a week, or by 30% if patient is meeting that goal already, for 6 months period of time.
SECONDARY OBJECTIVES:
I. To assess how patient?s physical activity level, without providing specific counseling or exercise regimen, compares to American Heart Association (AHA)?s recommendation and to the target of 10,000 steps promoted by various activity tracking devices.
II. To determine whether patients? perception on quality of life, physical activity and energy level assessed by questionnaires: Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Goldin Leisure-Time Exercise Questionnaire and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 and Ovarian Cancer (OV)28 correlates with activity tracked by the device.
III. To assess the association between subjectively measured sleep duration/quality (using the Pittsburgh Sleep Quality Scale), compared to sleeping pattern tracked by the activity device.
IV. To determine whether increased physical activity correlates with less chemotherapy related toxicity in the ovarian cancer patient population (any Common Terminology Criteria for Adverse Events \[CTCAE\] version 4, grade 3 or 4 toxicity).
EXPLORATORY OBJECTIVES:
I. To assess whether persistent increase of heart rate could predict adverse events related to surgery or adjuvant treatment.
II. To examine if the change in level of inflammatory biomarkers and T cell subsets in circulation correlates with increased physical activity.
III. To examine the immunoscore on tumor specimens and whether it correlates with level of physical activity.
IV. To examine the composition and diversity of gut microbiome in correlation with physical activity level.
OUTLINE:
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.
After completion of study, participants are followed up for up to 3 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: