Internet-Based Exercise and Diet Support in Prostate Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors

Conditions
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Cancer Survivor, Prostate Carcinoma

Intervention / Treatment
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* Behavioral: Written Information
* Behavioral: Prescription
* Behavioral: Technology
* Behavioral: Coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |