Trials / Recruiting

RecruitingNCT01365169

Association Between Health Care Provider (HCP)-Assessed ECOG Performance Status (PS) and Overall Survival, and Objectively Measure of Physical Activity (PA) Levels in Advance-cancer Patients"

"CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial"

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 590 (estimated)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The main goal of this phase of the study is to determine if objectively assessed Physical Activity (PA) levels in advanced-cancer patients are associated with health care provider (HCP)-assessed ECOG performance status and overall survival. The purpose is to advance the evidence-base for incorporating objective assessment of Physical Activity (PA) in the context of performance status assessment in advanced cancer patients.

Detailed description

PRIMARY OBJECTIVES: I. To explore the feasibility and acceptability in diverse samples of cancer patients of wireless collection and transmission of data for transfer into the open-source cyberinfrastructure (CI) called Cyberinfrastructure for Comparative Effectiveness Research (CYCORE). OUTLINE: Patients are assigned to 1 of 4 arms. ARM I (COLORECTAL CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a heart rate monitor, a global positioning system (GPS) device, and a smart phone that prompts patients to electronically answer questions about exercise and health-related symptoms and feelings. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days. ARM II (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use two accelerometers, a blood pressure monitor, a weight scale, and a smart phone that prompts patients to electronically answer questions about diet and health-related symptoms. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days. ARM III (HEAD AND NECK CANCER PATIENTS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a smart phone that prompts patients to electronically answer questions about diet, health-related symptoms, and swallowing exercises. Patients also take video recordings of their neck while performing swallowing exercises. The device is used for 5 consecutive days. After a 2 week period, patients resume use of the device for an additional 5 days. ARM IV (CANCER SURVIVORS THAT ARE CURRENT/FORMER SMOKERS) (CLOSED TO ACCRUAL AS OF 01/30/14): Patients use a carbon monoxide (CO) monitor and a smart phone that prompts patients to electronically answer questions about smoking. Patients also take video recordings of themselves while exhaling into the CO monitor. The devices are used for 5 consecutive days. After a 2 week period, patients resume use of the devices for an additional 5 days. PANCREATIC CANCER STUDY (PCS): Patients receive post-surgical wellness program consisting of physical activity, nutrition counseling, and daily monitoring (physical activity, weight, and self-reported data) for up to 7 months post-op. Technological Approach to Performance Status (TAPS) Study: Patients use two Physical Activity monitor devices, the wrist-worn device (Fitbit) continuously and the Actigraph during waking hours. Patients use the devices for 7 consecutive days.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Intervention	Participate in walking and/or strengthening program
OTHER	Health Telemonitoring	Use accelerometers, blood pressure monitor, heart rate monitor, GPS device, and smart phone
OTHER	Health Telemonitoring	Use accelerometers, blood pressure monitor, weight scale, and smart phone
OTHER	Health Telemonitoring	Use smart phone
OTHER	Health Telemonitoring	Use CO monitor and smart phone
OTHER	Health Telemonitoring	Use Fitbit, weight scale and iPhone- or web-based app for self-reported data
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Health Telemonitoring	Use Fitbit and Actigraph

Timeline

Start date: 2011-05-25
Primary completion: 2027-06-30
Completion: 2027-06-30
First posted: 2011-06-03
Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01365169. Inclusion in this directory is not an endorsement.