Using Walk With Ease Walking Program With Men 65 and Older Being Treated for Prostate Cancer

December 2, 2015 updated by: UNC Lineberger Comprehensive Cancer Center

Feasibility of an Evidence-based Walking Program in a Sample of Men Age >65 Undergoing Treatment for Prostate Cancer

This study is testing a walking program called Walk with Ease by the Arthritis Foundation with men undergoing treatment for prostate cancer. The researchers are interested in how easy or difficult it is for these men to participate in this program and whether or not is is helpful to them during their care.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Purpose: This pilot study evaluates the feasibility of implementing a moderate-intensity physical activity (PA) program in a sample of men age 65 or older with a prostate cancer diagnosis undergoing various forms of treatment or active surveillance.

Participants: Men, 65 and older, with a prostate cancer diagnosis.

Procedures (methods): This study will enroll subjects in a 6 week walking program called Walk with Ease (WWE) and see if walking can be sustained for up to three months. In addition, the study will perform a Geriatric Assessment and gather preliminary data on self-reported quality of life outcomes and self-reported physical activity as captured in a daily walking log.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men aged 65 and older with Prostate Cancer

Description

Inclusion Criteria:

  • ≥65 years of age
  • Histologically confirmed Stage I, II or III prostate cancer (endocrine (± radiation) patients may be Stage IV)
  • Undergoing prostate cancer treatment (post-surgery only, radiation only, endocrine therapy (± radiation), or active surveillance)
  • 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
  • Major surgery scheduled within the study period
  • Unable to walk or engage in moderate-intensity physical activity
  • Already actively walking (150 minutes per week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active Survelliance
Men age 65 and older who are undergoing active surveillance as primary treatment for their prostate cancer.
Behavioral: Walk with Ease
A six week walking program by the Arthritis Foundation
Radiation
Men age 65 and older who are undergoing radiation only as primary treatment for their prostate cancer.
Behavioral: Walk with Ease
A six week walking program by the Arthritis Foundation
Endocrine Therapy
Men age 65 and older who are undergoing endocrine therapy as primary treatment for their prostate cancer.
Behavioral: Walk with Ease
A six week walking program by the Arthritis Foundation
Surgery
Men age 65 and older who are undergoing surgery as primary treatment for their prostate cancer.
Behavioral: Walk with Ease
A six week walking program by the Arthritis Foundation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the feasibility of implementing the WWE intervention among men age >65 with a prostate cancer diagnosis
Time Frame: 24 months
Exploring the evaluate the feasibility of implementing the WWE intervention among men age >65 with a prostate cancer diagnosis. The study will measure those who were able to complete the program and increased their self-reported level of walking. The study will also measure the percent of patients who reach the goal of walking 30 minutes a day for 5 days a week in order to determine feasibility.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the rate of completion for study surveys
Time Frame: 24 months

To evaluate the rate of completion of each of the following measures/assessments at 3 different time points -- baseline, 6 weeks (end of WWE intervention), and 3 months (follow-up):

  • Self-reported walking log
  • Functional Assessment of Cancer Therapy-General (FACT-G)25
  • Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue26
  • Outcome Expectations for Exercise (OEE) scale27
  • Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)28,29
  • Visual Analog Scales (VAS) for Pain, Fatigue and Stiffness30-32
  • PROMIS Pain Interference Short Form 6b33-35
  • BRFSS Questionnaire 2011 -Health Behaviors Questionnaire (HBQ)36
  • Geriatric Assessment (GA) (Version 5)
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use primary data to design future studies
Time Frame: 36 months
To explore data from the measures/assessments (summary measures at each time point and mean changes at 6 weeks and 3 months) to inform future studies designed to evaluate associations between the WWE program and these variables.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Hyman Muss, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC1320
  • 13-2929 (Other Identifier: UNC IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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