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

NCT03685695 | Completed Phase 2

• 2 other identifiers: I 45817NCI-2018-00343
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 3 years

Secondary Outcomes (3)

• Change in Quality of Life Questionnaire scores

  Up to 3 years

• Daily steps

  Up to 3 years

• Heart Rate

  Up to 3 years

Study Arms (1)

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.

Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Physical Activity; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Supportive care (physical activity)

Monitoring Device DEVICE

Wear Fitbit Charge 2

Also known as: Monitor

Supportive care (physical activity)

Physical Activity OTHER

Complete aimed walking steps

Supportive care (physical activity)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (physical activity)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (physical activity)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Monitoring, Physiologic; Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emese Zsiros

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 26, 2018
• Study Start: June 27, 2017
• Primary Completion: August 1, 2019
• Study Completion: July 30, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

US (1)