Clinical trial NCT02139774: Using Walk With Ease Walking Program With Men 65 and Older Being Treated for Prostate Cancer
Official title: Feasibility of an Evidence-based Walking Program in a Sample of Men Age >65 Undergoing Treatment for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Elderly
Geriatric
Radiation
Arthritis
Exercise
Walking
Endocrine Therapy
Androgen Deprivation Therapy
Active Surveillance
Men
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 15
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men aged 65 and older with Prostate Cancer

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.

Eligibility 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)

Primary outcomes:
measure: To measure the feasibility of implementing the WWE intervention among men age >65 with a prostate cancer diagnosis
timeFrame: 24 months
Secondary outcomes:
measure: Measure the rate of completion for study surveys
timeFrame: 24 months
Other outcomes:
measure: Use primary data to design future studies
timeFrame: 36 months
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Hyman Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: