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

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.

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