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

Sponsor

UNC Lineberger Comprehensive Cancer Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02139774

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Oct 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	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

Primary Outcome Measures

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

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)

Other Outcome Measures

Use primary data to design future studies [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

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)