CYCORE: Cyberinfrastructure for Comparative Effectiveness Research - Feasibility Trial

Status: Recruiting

Location: See location...

Intervention Type: Other, Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

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• 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, nasopharyngeal, salivary gland or oral cavity; stage 3-4b laryngeal; any unknown primary head and neck cancer with cervical metastasis that will be addressed with treatment to bilateral necks and mucosa; or other head and neck cancers medically approved by one of our Radiation Oncology collaborating medical doctors (MDs) (Arms 2 and 3)

• History of any cancer, other than non-melanoma skin cancer (Arm 4)

• Admitted to being a current smoker or recent quitter upon admission to MD Anderson Cancer Center (MDACC) (Arm 4)

• Has a valid home address and functioning home telephone number (Arm 4)

• Lives in the Houston or surrounding area, or resides in this same area during the time period that coincides with this study (Arms 1-4)

• Patients who will undergo curative pancreatectomy for pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, or pancreatic cysts (malignant or benign) (PCS study)

• Fluent in English (PCS study)

• Must have telephone access and agree to engage with research personnel using telephone (PCS study)

• Diagnosis of a metastatic or locally unresectable solid tumor (TAPS study)

• Fluent in English (TAPS study)

• Age 18 years or older (TAPS study)

• ECOG performance status score between 0-3 (TAPS study)

Locations

United States

Texas

M D Anderson Cancer Center

RECRUITING

Houston

Contact Information

Primary

Susan Peterson

speterso@mdanderson.org

713-792-8267

Time Frame

Start Date: 2011-05-25

Estimated Completion Date: 2027-06-30

Participants

Target number of participants: 590

Treatments

Experimental: 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 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.

Experimental: 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.

Experimental: 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.

Experimental: Arm IV (cancer survivors that are current/former smokers)

(CLOSED TO ACCRUAL AS OF 01/30/14) Patients use a 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.

Experimental: PCS (pancreatic surgery patients)

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.

Experimental: TAPS (Technological Approach to Performance Status)

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.

Authors

Susan Peterson

Related Therapeutic Areas

Nasopharyngeal Carcinoma

Colorectal Cancer