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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Survivor; Prostate Carcinoma
• Intervention / Treatment: Behavioral: Written Information; Behavioral: Prescription; Behavioral: Technology; Behavioral: Coaching

Detailed Description

PRIMARY OBJECTIVES:

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • UCSF Medical Center-Mount Zion
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
  • burning or cramping sensations in your lower legs when walking short distance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Written Information	Behavioral: Written Information; Receive written information on diet and exercise relevant to older men with prostate cancer
Experimental: Group II; Written Information Prescription	Behavioral: Written Information; Receive written information on diet and exercise relevant to older men with prostate cancer; Behavioral: Prescription; Participants receive tailored exercise prescription and tailored diet recommendations
Experimental: Group III; Written Information Prescription Technology	Behavioral: Written Information; Receive written information on diet and exercise relevant to older men with prostate cancer; Behavioral: Prescription; Participants receive tailored exercise prescription and tailored diet recommendations; Behavioral: Technology; Participants receive motivational text messages and can electronically log and track their exercise and diet habits
Experimental: Group IV; Written Information Prescription Technology Coaching	Behavioral: Written Information; Receive written information on diet and exercise relevant to older men with prostate cancer; Behavioral: Prescription; Participants receive tailored exercise prescription and tailored diet recommendations; Behavioral: Technology; Participants receive motivational text messages and can electronically log and track their exercise and diet habits; Behavioral: Coaching; Participants receive access to an exercise and diet coach to provide advice by phone and/or email

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity survey	CHAMPS estimates total weekly energy expenditure (in kilocalories per week) from low to vigorous intensity physical activities for older adults.	Baseline, 3 months, and 6 months
Harvard T.H. Chan School of Public Health Food Frequency Questionnaire for adults from 2007	This 132-item survey assesses dietary intake over the past month in categories from "never or less than once per month" to "6 or more times per day" and supports examining major food and nutrient categories of the U.S. diet.	Baseline, 3 months, and 6 months
Self-Efficacy for Exercise	A 6-item measure of Self-efficacy for Exercise will be used. Summed scores range from 6-30, and higher scores indicate higher self-efficacy.	Baseline, 3 months, and 6 months
Physical Activity Stage Assessment	This 5-question measure asks the person to select one description, from a choice of five, which describes his current activity behavior.	Baseline, 3 months, and 6 months
Charlson Comorbidity Index	The Charlson Comorbidity Index is a weighted index to predict mortality. Scores range from 0-37, with higher scores indicating more chronic medical conditions.	Baseline, 3 months, and 6 months
Self-Efficacy for Diet	Diet self-efficacy will be measured by having participants rate their confidence in performing each recommended task (e.g., two more servings of cooked tomatoes per week) using a Likert scale.	Baseline, 3 months, and 6 months
Pittsburgh Sleep Quality Index	This self-report questionnaire assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.	Baseline, 3 months, and 6 months
Memorial Anxiety Scale for Prostate Cancer (MAX-PC)	MAX-PC is an 18 item scale to facilitate the identification and assessment of men with prostate cancer-related anxiety. This scale consists of three subscales that measure general prostate cancer anxiety, anxiety related to prostate specific antigen (PSA) levels in particular, and fear of recurrence.	Baseline, 3 months, and 6 months
PROMIS 7-item Short Form - Fatigue	PROMIS - Fatigue evaluates self-reported symptoms of fatigue, from mild subjective feelings of tiredness to an overwhelming sense of exhaustion over the past seven days.	Baseline, 3 months, and 6 months
Behavioral Regulation in Exercise Questionnaire (BREQ2)	BREQ2 measures the continuum of behavioral regulation in exercise psychology research. This questionnaire concerns the reasons why a person exercises regularly, works out, or engages in other such physical activities. It is structured so that it asks one question and provides responses that represent external regulation, introjected regulation, identified regulation, and intrinsic motivation.	Baseline, 3 months, and 6 months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	EORTC QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients and has five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. Scores range from 0-100, with higher functional scale scores indicating a higher level of healthy functioning while a higher score for a symptom scale represents a higher level of symptomatology or problems.	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Movember Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: July 22, 2017
• First Submitted That Met QC Criteria: January 13, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STUDY00016703 (Other Identifier: OHSU Knight Cancer Institute); NCI-2017-01048 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No