MedDataX Logo

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

NCT ID: NCT02139774

Last Updated: 2015-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Survelliance

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

Walk with Ease

Intervention Type BEHAVIORAL

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.

Walk with Ease

Intervention Type BEHAVIORAL

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.

Walk with Ease

Intervention Type BEHAVIORAL

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.

Walk with Ease

Intervention Type BEHAVIORAL

A six week walking program by the Arthritis Foundation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Walk with Ease

A six week walking program by the Arthritis Foundation

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyman Muss, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://unclineberger.org/geriatric

Website for the Geriatric Oncology program at UNC Chapel Hill

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-2929

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC1320

Identifier Type: -

Identifier Source: org_study_id