Feasibility of Activity Monitoring in Patients With Cancer: Physical Activity Monitoring in Cancer Patients (PAMCaP)

NCT02583815 | Completed DMC

• 1 other identifier: STU 062015-021
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label feasibility pilot study of commercially available physical activity monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer Center, UT Southwestern Medical Center.

Conditions

Gastrointestinal Cancer; Breast Cancer; Gynecologic Cancer; Genitourinary Cancer; Leukemia; Lung Cancer; Skin Cancer; Endocrine Cancer; Male Genital Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Use PAM Device

  The primary endpoint of the study is the feasibility defined by subjects who use a PAM device for more than 42 of 84 days in the observation period (12 weeks +/- 14 days)

  Week 6 until week 12

Secondary Outcomes (8)

• Number of Steps

  12 Weeks (+/- 14 days)

• Distance Walked

  12 Weeks (+/- 14 days)

• Time Spent in Activity

  12 Weeks (+/- 14 days)

• Eastern Cooperative Oncology Group Performance Status

  Baseline and every 4 weeks for 12 weeks (+/-14 days)

• Functional Assessment of Cancer Therapy. (FACT-G)

  Baseline and every 4 weeks for 12 weeks (+/-14 days)

Study Arms (1)

Cancer Patients

This is an open label feasibility pilot study of commercially available physical activity monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer Center, UT Southwestern Medical Center.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving systemic therapy at the Harold Simmons Cancer Center, UT Southwestern Medical Center.

You may qualify if:

• Signed informed consent
• Age 18 or above
• Receiving or planning to receive outpatient therapy for any cancer
• Baseline ECOG status 0-2;
• Speak and understand English as all Psychological assessment tools included in this study have not been validated in Spanish;
• Access to smartphone device compatible to sync with PAM Device

You may not qualify if:

• Recent injury which may result in impaired mobility;
• Major surgery within 4 weeks or till recovery to baseline functioning (per patient) whichever is shorter;
• Inability to comply with study requirement;
• Medical, psychiatric condition which in the investigators opinion will affect the successful completion of study;
• Current use of a wearable PAM device as defined by use of PAM device in the last 6 months

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-8852, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected at each study visit (Baseline, then every weeks until week 12 (+/-14 days). Prior to storage, complete the sample inventory logs for each subject so that specimen chain of custody can be established. Samples will be frozen at -80°C until the time of analysis. Include in each shipment batch copies of: 1) the blood collection source documents for each patient; and 2) copies of each subjects specimen inventory form Keep originals of these documents in the subject's chart Samples will be analyzed using a multiplexed ELISA method (Meso Scale Discovery) for IL-1beta, IL-6, IL-10 and TNF-alpha With explicit participant consent, samples will also be processed for DNA and stored for future analysis.

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Breast Neoplasms; Urogenital Neoplasms; Leukemia; Lung Neoplasms; Skin Neoplasms; Endocrine Gland Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine System Diseases

Study Officials

• Muhammad Beg, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: August 1, 2015
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)