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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months after baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 months after baseline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ECOG Performance Status

Physical Activity (PA) Assessment

Study completion (defined as completing the final assessment)

Secondary outcome measures

Acceptability of using home-based health monitor devices (e.g. Fitbit, Actigraph, CO monitor, weight scales) among participants.

Accrual of Diverse Sample of Cancer-Patients

Adherence to procedures for home-based health monitor devices activation (e.g. Fitbit, Actigraph, CO monitor, weight scales) self-monitoring (e.g. PA, weight), and self-reported data capture by the devices.

+7 more

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,977 Previous Clinical Trials

1,788,948 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,692 Previous Clinical Trials

40,929,966 Total Patients Enrolled

Susan K PetersonPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Health Telemonitoring Clinical Trial Eligibility Overview. Trial Name: NCT01365169 — N/A

Head and Neck Cancers Research Study Groups: Arm II (head and neck cancer patients), Arm I (colorectal cancer patients), PCS (pancreatic surgery patients), Arm IV (cancer survivors that are current/former smokers), TAPS (Technological Approach to Performance Status), Arm III (head and neck cancer patients)

Head and Neck Cancers Clinical Trial 2023: Health Telemonitoring Highlights & Side Effects. Trial Name: NCT01365169 — N/A

Health Telemonitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT01365169 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to enroll in this medical trial?

"According to the information hosted on clinicaltrials.gov, this study is still recruiting patients. It was initially posted in May of 2011 and updated as recently as May 2022."

Answered by AI

How many participants are being enrolled in this experiment?

"Affirmative. According to evidence found on clinicaltrials.gov, this research endeavour has been open for patient recruitment since May 25th 2011 and was recently updated on the same date in 2022. 590 volunteers are required from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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"

2011. "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"". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01365169.

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