Internet-Based Exercise and Diet Support in Prostate Cancer Survivors
NCT ID: NCT03406013
Last Updated: 2020-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
206 participants
INTERVENTIONAL
2017-08-01
2020-03-31
Brief Summary
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Detailed Description
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I. To determine the feasibility and acceptability of the Community of Wellness web portal among prostate cancer survivors by conducting a randomized controlled study comparing four levels of web-based content and interaction with participants.
SECONDARY OBJECTIVES:
I. To compare efficacy of four levels of web-based content in the Community of Wellness web portal in a pilot randomized controlled trial on exercise and dietary habits, self-efficacy for behavior change, motivation for exercise, and changes in treatment-related side effects.
OUTLINE: Patients are assigned to 1 of 4 groups.
GROUP I: Patients receive "Written Information" which includes access to the TrueNTH open access portal that provides basic written information about exercise and diet.
GROUP II: Patients receive access to "Written Information + Prescription", including written information plus additional an exercise prescription and tailored diet recommendations.
GROUP III: Patients receive access to "Written Information + Prescription + Technology", including written information, exercise prescription + diet recommendation and additional technology components. Patients complete diet and exercise behavior logs and receive educational and motivational text messages about healthy diet and exercise habits.
GROUP IV: Patients receive access to "Written Information + Prescription + Technology + Coaching" and receive written information, exercise prescription + diet recommendation, technology support and a 30-minute (each) diet and exercise consultation plus the ability to receive ongoing advice from coaches via the web portal.
After completion of intervention, patients are followed up at 3 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I
Written Information
Written Information
Receive written information on diet and exercise relevant to older men with prostate cancer
Group II
Written Information Prescription
Written Information
Receive written information on diet and exercise relevant to older men with prostate cancer
Prescription
Participants receive tailored exercise prescription and tailored diet recommendations
Group III
Written Information Prescription Technology
Written Information
Receive written information on diet and exercise relevant to older men with prostate cancer
Prescription
Participants receive tailored exercise prescription and tailored diet recommendations
Technology
Participants receive motivational text messages and can electronically log and track their exercise and diet habits
Group IV
Written Information Prescription Technology Coaching
Written Information
Receive written information on diet and exercise relevant to older men with prostate cancer
Prescription
Participants receive tailored exercise prescription and tailored diet recommendations
Technology
Participants receive motivational text messages and can electronically log and track their exercise and diet habits
Coaching
Participants receive access to an exercise and diet coach to provide advice by phone and/or email
Interventions
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Written Information
Receive written information on diet and exercise relevant to older men with prostate cancer
Prescription
Participants receive tailored exercise prescription and tailored diet recommendations
Technology
Participants receive motivational text messages and can electronically log and track their exercise and diet habits
Coaching
Participants receive access to an exercise and diet coach to provide advice by phone and/or email
Eligibility Criteria
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Inclusion Criteria
* Able to read English on a computer screen
* Able to access a computer, tablet or smartphone at home or public location
* Access to a device capable of receiving plain text messages
* A personal email address
Exclusion Criteria
* heart attack
* heart surgery, cardiac catheterization, or coronary angioplasty
* pacemaker/implantable cardiac defibrillator/rhythm disturbance
* heart valve disease
* heart failure
* heart transplantation
* congenital heart disease
* diabetes
* kidney (renal) disease
* chest discomfort with exertion
* unreasonable breathlessness
* dizziness, fainting or blackouts
* ankle swelling
* unpleasant awareness of forceful, rapid or irregular heart rate
* burning or cramping sensations in your lower legs when walking short distance
18 Years
MALE
No
Sponsors
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Movember Foundation
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Kerri Winters
Principal Investigator
Principal Investigators
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Kerri Winters-Stone
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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UCSF Medical Center-Mount Zion
San Francisco, California, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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References
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Chan JM, Van Blarigan EL, Langlais CS, Zhao S, Ramsdill JW, Daniel K, Macaire G, Wang E, Paich K, Kessler ER, Beer TM, Lyons KS, Broering JM, Carroll PR, Kenfield SA, Winters-Stone KM. Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. J Med Internet Res. 2020 Dec 31;22(12):e19238. doi: 10.2196/19238.
Winters-Stone KM, Kenfield SA, Van Blarigan EL, Moe EL, Ramsdill JW, Daniel K, Macaire G, Paich K, Kessler ER, Kucuk O, Gillespie TW, Lyons KS, Beer TM, Broering JM, Carroll PR, Chan JM. Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Nov 15;7(11):e11257. doi: 10.2196/11257.
Other Identifiers
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NCI-2017-01048
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00016703
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00016703
Identifier Type: -
Identifier Source: org_study_id
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