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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Walk with Ease


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Elderly, Geriatric, Radiation, Arthritis, Exercise, Walking, Endocrine Therapy, Androgen Deprivation Therapy, Active Surveillance, Men