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

Terminated

• Conditions: Prostate Cancer
• Interventions: Behavioral: Walk with Ease

• Registration Number: NCT02139774
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery	Walk with Ease	Men age 65 and older who are undergoing surgery as primary treatment for their prostate cancer.
Endocrine Therapy	Walk with Ease	Men age 65 and older who are undergoing endocrine therapy as primary treatment for their prostate cancer.
Active Survelliance	Walk with Ease	Men age 65 and older who are undergoing active surveillance as primary treatment for their prostate cancer.
Radiation	Walk with Ease	Men age 65 and older who are undergoing radiation only as primary treatment for their prostate cancer.

Primary Outcome Measures

Name	Time	Method
To measure the feasibility of implementing the WWE intervention among men age >65 with a prostate cancer diagnosis	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

Name	Time	Method
Measure the rate of completion for study surveys	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)

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States