Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy (WWE)

This study is currently recruiting participants.
Verified February 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01789983
First received: February 8, 2013
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.


Condition Intervention
Breast Cancer
Colon Cancer
Lung Cancer
Behavioral: Walk With Ease Program
Other: Collect Blood, GA and Other Survey Tools

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Feasibility will be defined as the proportion of recruited subjects who complete the 6-week WWE program.


Secondary Outcome Measures:
  • To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The rate of completion of assessments will be measured at baseline, 6 weeks and end of chemotherapy treatment.

  • To measure relationships between physical activity levels and p16 levels. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To measure the association between number of minutes walked per day and number of times per week with p16 levels.


Biospecimen Retention:   Samples Without DNA

Whole Blood Sample


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast Cancer Patients 60+
Breast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease.
Behavioral: Walk With Ease Program

The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them.

The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program.

Other Name: WWE
Other: Collect Blood, GA and Other Survey Tools
  • Geriatric Assessment (GA) (Version 5)
  • Functional Assessment of Cancer Therapy-General (FACT)
  • Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36
  • Outcome Expectations for Exercise (OEE) scale29
  • Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy)
  • Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35
  • Visual Analog Scales (VAS)

Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis.

Lung Cancer Patients 60+
Lung Cancer Patients age 60 and above who have stage I, II or III disease
Behavioral: Walk With Ease Program

The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them.

The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program.

Other Name: WWE
Other: Collect Blood, GA and Other Survey Tools
  • Geriatric Assessment (GA) (Version 5)
  • Functional Assessment of Cancer Therapy-General (FACT)
  • Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36
  • Outcome Expectations for Exercise (OEE) scale29
  • Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy)
  • Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35
  • Visual Analog Scales (VAS)

Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis.

Colon Cancer Patients 60+
Colon cancer patients age 60 and above who have stage II or III disease.
Behavioral: Walk With Ease Program

The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them.

The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program.

Other Name: WWE
Other: Collect Blood, GA and Other Survey Tools
  • Geriatric Assessment (GA) (Version 5)
  • Functional Assessment of Cancer Therapy-General (FACT)
  • Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36
  • Outcome Expectations for Exercise (OEE) scale29
  • Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy)
  • Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35
  • Visual Analog Scales (VAS)

Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis.


Detailed Description:

The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program.

We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Colon, lung and breast cancer patients age 60 and above who are beginning chemotherapy or chemoradiation treatment.

Criteria

Inclusion Criteria:

  • ≥60 years of age, male or female
  • Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis); Stage I, II or III lung cancer, or Stage II or III colon cancer
  • Scheduled to begin a chemotherapy (or concomitant chemoradiotherapy) regimen that will last at least 6 weeks in duration
  • English speaking
  • IRB approved, signed written informed consent
  • Approval from their treating physician to engage in moderate-intensity physical activity
  • Patient-assessed ability to walk and engage in moderate physical activity
  • Willing and able to meet all study requirements.

Exclusion Criteria:

  • One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
  • Cancer surgery scheduled within the study period
  • Unable to walk or engage in moderate-intensity physical activity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789983

Contacts
Contact: Shani M Alston, MPH 919-843-1906 shani_alston@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Cancer Hospital Recruiting
Chapell Hill, North Carolina, United States, 27514
Sub-Investigator: Bert O'Neil, MD         
Sub-Investigator: Norman E Sharpless, MD         
Sub-Investigator: Jared Weiss, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Hyman Muss, MD University of North Carolina Lineberger Comprehensive Cancer Center
Principal Investigator: Kirsten A Nyrop, PhD University of North Carolina Thurston Arthritis Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01789983     History of Changes
Other Study ID Numbers: LCCC1226, 12-1975
Study First Received: February 8, 2013
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Physical Activity
Chemotherapy
Elderly
Geriatric
Walking
Geriatric Assessment
Geriatric Oncology

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014