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Physical Activity Monitoring for Cancer Prognosis

N/A

Recruiting

Led By Susan K Peterson

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients who will undergo curative pancreatectomy for specified pancreatic conditions (PCS study)

Must not have

Major surgery in the past 8 weeks (Arms 1 and 4)

Zubrod performance status > 2, or self-reports either not being up and about more than 50% of waking hours or unable to provide self-care (Arms 2 and 3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether patients' objectively-measured physical activity levels are associated with their health care providers' assessments of their cancer prognoses and overall survival rates.

Who is the study for?

This trial is for adults with various advanced cancers, including head and neck, colorectal, and solid tumors. Participants must be able to consent, live in the Houston area, speak English fluently, have an ECOG status of 0-3 (meaning they can care for themselves more than half the day), and have telephone access.

What is being tested?

The study aims to see if physical activity levels measured objectively are linked to health provider-assessed performance status and survival in advanced cancer patients. It involves health telemonitoring, questionnaires, exercise interventions, and quality-of-life assessments.

What are the potential side effects?

Since this trial focuses on monitoring physical activity rather than testing a drug or medical procedure directly, side effects may include discomfort from wearing monitoring devices or fatigue related to exercise intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had cancer before, but it was not non-melanoma skin cancer.

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I am scheduled for a surgery to remove my pancreas for a cure.

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My cancer has spread and cannot be removed by surgery.

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I can care for myself but may not be able to do heavy physical work.

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I have been diagnosed with colorectal cancer at any stage or it has come back.

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I have been diagnosed with a specific type of head or neck cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 8 weeks.

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I spend more than half of my day in bed or seated and cannot care for myself.

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I sometimes get confused about the time, who I am, or where I am.

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I am not currently undergoing radiation treatment for my cancer.

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I have high blood pressure that I'm not managing or monitoring with a doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ECOG Performance Status

Physical Activity (PA) Assessment

Secondary study objectives

Correlation between PA data and Overall Survivor (OS)

Correlation between PA data from the Actigraph and Fitbit

Correlation between patients' ECOG performance status scores and PA data

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: TAPS (Technological Approach to Performance Status)Experimental Treatment1 Intervention

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.

Group II: PCS (pancreatic surgery patients)Experimental Treatment4 Interventions

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.

Group III: Arm IV (cancer survivors that are current/former smokers)Experimental Treatment2 Interventions

(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.

Group IV: Arm III (head and neck cancer patients)Experimental Treatment2 Interventions

(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.

Group V: Arm II (head and neck cancer patients)Experimental Treatment2 Interventions

(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.

Group VI: Arm I (colorectal cancer patients)Experimental Treatment2 Interventions

(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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Intervention

2016

Completed Phase 4

~1330

0 / 12Eligibility criteria met