Fallopian Tube Endometrioid TumorPhase 2NCT03685695
Physical Activity Monitored by Fitbit Charge 2 in Improving Quality of Life in Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 2 study testing Laboratory Biomarker Analysis, Monitoring Device and Physical Activity in people with Fallopian Tube Endometrioid Tumor and Fallopian Tube Mucinous Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Endometrioid Tumor, Fallopian Tube Mucinous Neoplasm, Fallopian Tube Serous Neoplasm
- What is being tested?
- Laboratory Biomarker Analysis, Monitoring Device and Physical Activity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2017to 30 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Conditions
- Fallopian Tube Endometrioid Tumor, Fallopian Tube Mucinous Neoplasm, Fallopian Tube Serous Neoplasm, Ovarian Clear Cell Tumor, Ovarian Endometrioid Tumor, Ovarian Mucinous Tumor
- Being tested
- Laboratory Biomarker Analysis, Monitoring Device, Physical Activity, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Monitoring DeviceDevice
Also called Monitor
Wear Fitbit Charge 2
Physical ActivityOther
Complete aimed walking steps
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (physical activity) | Experimental | 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. Receives: Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Physical Activity; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who wear and track g data using the Fitbit Charge 2 activity wrist band
If observed compliance rate is 70% , use of the device will be deemed feasible.
Measured: Up to 3 years
Persuasive effect of using the Fitbit Charge 2 on physical activity (PA)
Will be assessed by comparing average daily PA measurements (described above) between pre- and post-counseling, using two-sided t-tests.
Measured: Up to 3 years
Secondary outcomes (3)
Change in Quality of Life Questionnaire scores
The EORTC QLQ-30 will assess perception of the quality of LIfe in cancer patients.
Measured: Up to 3 years
Daily steps
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.
Measured: Up to 3 years
Heart Rate
The heart rate recorded by the activity device will be averaged over the time periods between patient visits,
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start27 Jun 2017
- Primary completion1 Aug 2019
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube Endometrioid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emese Zsiros, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685695
- Sponsor's protocol ID
- I 45817
- Other IDs
- NCI-2018-00343, I 45817
- Status last verified
- Aug 2021
- First submitted
- 18 Sep 2018
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03685695
- Acronym / sponsor ID
- I 45817
- Conditions
- Fallopian Tube Endometrioid Tumor, Fallopian Tube Mucinous Neoplasm, Fallopian Tube Serous Neoplasm, Ovarian Clear Cell Tumor, Ovarian Endometrioid Tumor, Ovarian Mucinous Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (physical activity) | Experimental | Other: Laboratory Biomarker Analysis, Device: Monitoring Device, Other: Physical Activity, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive care (physical activity) |
| Monitoring DeviceAlso: MonitorWear Fitbit Charge 2 | Device | Supportive care (physical activity) |
| Physical ActivityComplete aimed walking steps | Other | Supportive care (physical activity) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (physical activity) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (physical activity) |
Primary outcome
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.
3 secondary outcomes
Change in Quality of Life Questionnaire scores
Time frame: Up to 3 years
Daily steps
Time frame: Up to 3 years
Heart Rate
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
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A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).
Ovarian Cancer Recurrent
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Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emese Zsiros principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis, Monitoring Device and Physical Activity in people with Fallopian Tube Endometrioid Tumor and Fallopian Tube Mucinous Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who wear and track g data using the Fitbit Charge 2 activity wrist band (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.