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

NCT02139774 | Terminated DMC

• 2 other identifiers: LCCC132013-2929
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Elderly; Geriatric; Radiation; Arthritis; Exercise; Walking; Endocrine Therapy; Androgen Deprivation Therapy; Active Surveillance; Men

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure the rate of completion for study surveys

  24 months

Other Outcomes (1)

• Use primary data to design future studies

  36 months

Study Arms (4)

Active Survelliance

Men age 65 and older who are undergoing active surveillance as primary treatment for their prostate cancer.

Behavioral: Walk with Ease

Radiation

Men age 65 and older who are undergoing radiation only as primary treatment for their prostate cancer.

Behavioral: Walk with Ease

Endocrine Therapy

Men age 65 and older who are undergoing endocrine therapy as primary treatment for their prostate cancer.

Behavioral: Walk with Ease

Surgery

Men age 65 and older who are undergoing surgery as primary treatment for their prostate cancer.

Behavioral: Walk with Ease

Interventions

Walk with Ease BEHAVIORAL

A six week walking program by the Arthritis Foundation

Active Survelliance; Endocrine Therapy; Radiation; Surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men aged 65 and older with Prostate Cancer

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Website for the Geriatric Oncology program at UNC Chapel Hill

MeSH Terms

Conditions

Prostatic Neoplasms; Arthritis; Motor Activity; Multiple Endocrine Neoplasia Type 1

Interventions

Walking; methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Joint Diseases; Musculoskeletal Diseases; Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Hyman Muss, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: May 15, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

US (1)