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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02139774
• Other study ID #: LCCC1320
• Secondary ID: 13-2929
• Status: Terminated
• Phase: N/A
• First received: February 26, 2014
• Last updated: December 2, 2015
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Walk with Ease
A six week walking program by the Arthritis Foundation

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use primary data to design future studies	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	No
Primary	To measure the feasibility of implementing the WWE intervention among men age >65 with a prostate cancer diagnosis	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	No
Secondary	Measure the rate of completion for study surveys	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	No

External Links

•   Website for the Geriatric Oncology program at UNC Chapel Hill