Prostate Cancer
Conditions
Keywords
Prostate Cancer, Elderly, Geriatric, Radiation, Arthritis, Exercise, Walking, Endocrine Therapy, Androgen Deprivation Therapy, Active Surveillance, Men
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.
Interventions
BEHAVIORALWalk with Ease
A six week walking program by the Arthritis Foundation
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed