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

M.D. Anderson Cancer Center

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.

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 qu…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Diagnosis of any stage I - IV colorectal cancer or recurrent colorectal cancer (Arm 1) * Able to speak, read, and write in English (Pre-pilot phase, Arms 1-4) * Able to provide informed consent (Pre-pilot phase, Arms 1-4, PCS study) * Lives in the Houston area (Harris county or a contiguous county) (Pre-pilot phase) * Eastern Cooperative Oncology Group (ECOG) status of 0 - 2, or self-reports being up and about more than 50% of waking hours and able to provide self-care (Arm 1) * Diagnosis of any of the following cancers: stage 1-4b oropharyngeal, hypopharyngeal, nasophar…

Interventions

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

Summary

Description

Eligibility

Interventions

Location