Clinical trial · Interventional
Physical Activity Monitored by Fitbit Charge 2 in Improving Quality of Life in Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Endometrioid Tumor | Fallopian Tube Endometrioid Tumor | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Mucinous Neoplasm | Fallopian Tube Mucinous Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Serous Neoplasm | Fallopian Tube Serous Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Tumor | Ovarian Clear Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Tumor | Ovarian Endometrioid Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Mucinous Tumor | Ovarian Mucinous Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Serous Tumor | Ovarian Serous Tumor | ONTOLOGY_EXACT |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Monitoring Device | Device | — | UNRESOLVED |
| Physical Activity | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (physical activity)
- description
- 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.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Device: Monitoring Device
- Other: Physical Activity
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Number of participants who wear and track g data using the Fitbit Charge 2 activity wrist band
- timeFrame
- Up to 3 years
- description
- If observed compliance rate is 70% , use of the device will be deemed feasible.
- measure
- Persuasive effect of using the Fitbit Charge 2 on physical activity (PA)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available