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

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ClinicalTrials.gov Identifier: NCT02139774
Recruitment Status : Terminated (inadequate accrual)
First Posted : May 15, 2014
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Behavioral: Walk with Ease

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 Design
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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of an Evidence-based Walking Program in a Sample of Men Age >65 Undergoing Treatment for Prostate Cancer
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men aged 65 and older with Prostate Cancer
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139774


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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Principal Investigator: Hyman Muss, MD University of North Carolina, Chapel Hill
More Information
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Additional Information:

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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02139774    
Other Study ID Numbers: LCCC1320
13-2929 ( Other Identifier: UNC IRB )
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: December 2015
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Prostate Cancer
Elderly
Geriatric
Radiation
Arthritis
Exercise
 Walking
Endocrine Therapy
Androgen Deprivation Therapy
Active Surveillance
Men
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases