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| ID | Type | Description | Link |
|---|---|---|---|
| 13-2929 | Other Identifier | UNC IRB |
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inadequate accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Survelliance | Men age 65 and older who are undergoing active surveillance as primary treatment for their prostate cancer. |
| |
| Radiation | Men age 65 and older who are undergoing radiation only as primary treatment for their prostate cancer. |
| |
| Endocrine Therapy | Men age 65 and older who are undergoing endocrine therapy as primary treatment for their prostate cancer. |
| |
| Surgery | Men age 65 and older who are undergoing surgery as primary treatment for their prostate cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk with Ease | Behavioral | A six week walking program by the Arthritis Foundation |
|
| 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 |
| 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):
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Men aged 65 and older with Prostate Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Hyman Muss, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| Website for the Geriatric Oncology program at UNC Chapel Hill | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001168 | Arthritis |
| D009043 | Motor Activity |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016138 | Walking |
| C034430 | methyl hydroxyethyl cellulose |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 24 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001519 | Behavior |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D015444 | Exercise |
| D009043 | Motor Activity |