Prostate CancerNCT02139774
Using Walk With Ease Walking Program With Men 65 and Older Being Treated for Prostate Cancer
An observational study of Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Walk with Ease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: Men aged 65 and older with Prostate Cancer
Who may be able to join
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Feasibility of an Evidence-based Walking Program in a Sample of Men Age >65 Undergoing Treatment for Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Walk with Ease
- Keywords
- Prostate Cancer, Elderly, Geriatric, Radiation, Arthritis, Exercise, Walking, Endocrine Therapy, Androgen Deprivation Therapy, Active Surveillance, Men
- Medical subject headings
- Prostatic Neoplasms, Arthritis, Motor Activity, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk with EaseBehavioural
A six week walking program by the Arthritis Foundation
| Study group | Role | What they receive |
|---|---|---|
| Active Survelliance | Men age 65 and older who are undergoing active surveillance as primary treatment for their prostate cancer. Receives: Behavioral: Walk with Ease | |
| Radiation | Men age 65 and older who are undergoing radiation only as primary treatment for their prostate cancer. Receives: Behavioral: Walk with Ease | |
| Endocrine Therapy | Men age 65 and older who are undergoing endocrine therapy as primary treatment for their prostate cancer. Receives: Behavioral: Walk with Ease | |
| Surgery | Men age 65 and older who are undergoing surgery as primary treatment for their prostate cancer. Receives: Behavioral: Walk with Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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):
- 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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: inadequate accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139774
- Sponsor's protocol ID
- LCCC1320
- Other IDs
- 13-2929
- Status last verified
- Dec 2015
- First submitted
- 26 Feb 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Evidence-based Walking Program in a Sample of Men Age >65 Undergoing Treatment for Prostate Cancer
- ClinicalTrials.gov ID
- NCT02139774
- Acronym / sponsor ID
- LCCC1320
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Elderly, Geriatric, Radiation, Arthritis, Exercise, Walking, Endocrine Therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inadequate accrual
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Survelliance | – | Behavioral: Walk with EaseMen age 65 and older who are undergoing active surveillance as primary treatment for their prostate cancer. |
| Radiation | – | Behavioral: Walk with EaseMen age 65 and older who are undergoing radiation only as primary treatment for their prostate cancer. |
| Endocrine Therapy | – | Behavioral: Walk with EaseMen age 65 and older who are undergoing endocrine therapy as primary treatment for their prostate cancer. |
| Surgery | – | Behavioral: Walk with EaseMen age 65 and older who are undergoing surgery as primary treatment for their prostate cancer. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Men aged 65 and older with Prostate Cancer
Key inclusion criteria (8 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk with EaseA six week walking program by the Arthritis Foundation | Behavioural | Active Survelliance, Endocrine Therapy, Radiation, Surgery |
Primary outcome
To measure the feasibility of implementing the WWE intervention among men age >65 with a prostate cancer diagnosis
Time frame: 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.
1 secondary outcome
Measure the rate of completion for study surveys
Time frame: 24 months
Results and safety
The study was stopped early (reason given: inadequate accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Website for the Geriatric Oncology program at UNC Chapel HillLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyman Muss, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inadequate accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the feasibility of implementing the WWE intervention among men age >65 with a prostate cancer diagnosis (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015; AzTrials last refreshed its copy on 28 Oct 2026.