Internet-Based Exercise and Diet Support in Prostate Cancer Survivors
True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors
2 other identifiers
interventional
206
1 country
2
Brief Summary
This pilot clinical trial studies how well the True NTH Community of Wellness internet-based exercise and diet support works in improving diet and exercise habits in prostate cancer survivors. Internet-based exercise and diet support may help better control treatment-related side effects and symptoms, better overall quality of life, and lower risk factors associated with cancer progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedJuly 29, 2020
July 1, 2020
2 years
July 22, 2017
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Accrual success
Measured as ability to recruit target sample size within one year
Up to 3 months
Retention
Measured as the % of men who complete post-intervention and follow-up measures out of the total # of men enrolled
Up to 6 months
Adherence to the study
Measured as the # of times that a man visits the portal over three months
Up to 3 months
Secondary Outcomes (11)
Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity survey
Baseline, 3 months, and 6 months
Harvard T.H. Chan School of Public Health Food Frequency Questionnaire for adults from 2007
Baseline, 3 months, and 6 months
Self-Efficacy for Exercise
Baseline, 3 months, and 6 months
Physical Activity Stage Assessment
Baseline, 3 months, and 6 months
Charlson Comorbidity Index
Baseline, 3 months, and 6 months
- +6 more secondary outcomes
Study Arms (4)
Group I
ACTIVE COMPARATORWritten Information
Group II
EXPERIMENTALWritten Information Prescription
Group III
EXPERIMENTALWritten Information Prescription Technology
Group IV
EXPERIMENTALWritten Information Prescription Technology Coaching
Interventions
Receive written information on diet and exercise relevant to older men with prostate cancer
Participants receive tailored exercise prescription and tailored diet recommendations
Participants receive motivational text messages and can electronically log and track their exercise and diet habits
Participants receive access to an exercise and diet coach to provide advice by phone and/or email
Eligibility Criteria
You may qualify if:
- Self-reported prostate cancer diagnosis
- 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
You may not qualify if:
- Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria and who do not receive a physician clearance to participate in the moderate intensity physical activity with one or more of the following self-reported conditions:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- Movember Foundationcollaborator
Study Sites (2)
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (2)
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.
PMID: 33382378DERIVEDWinters-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.
PMID: 30442638DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerri Winters-Stone
OHSU Knight Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 22, 2017
First Posted
January 23, 2018
Study Start
August 1, 2017
Primary Completion
July 31, 2019
Study Completion
March 31, 2020
Last Updated
July 29, 2020
Record last verified: 2020-07