Internet-Based Exercise and Diet Support in Prostate Cancer Survivors
- Conditions
- Cancer SurvivorProstate Carcinoma
- Interventions
- Behavioral: Written InformationBehavioral: PrescriptionBehavioral: TechnologyBehavioral: Coaching
- Registration Number
- NCT03406013
- Lead Sponsor
- OHSU Knight Cancer Institute
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 206
- 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
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group II Prescription Written Information Prescription Group I Written Information Written Information Group III Written Information Written Information Prescription Technology Group IV Technology Written Information Prescription Technology Coaching Group II Written Information Written Information Prescription Group IV Written Information Written Information Prescription Technology Coaching Group IV Prescription Written Information Prescription Technology Coaching Group III Prescription Written Information Prescription Technology Group III Technology Written Information Prescription Technology Group IV Coaching Written Information Prescription Technology Coaching
- Primary Outcome Measures
Name Time Method Retention Up to 6 months Measured as the % of men who complete post-intervention and follow-up measures out of the total # of men enrolled
Adherence to the study Up to 3 months Measured as the # of times that a man visits the portal over three months
Accrual success Up to 3 months Measured as ability to recruit target sample size within one year
- Secondary Outcome Measures
Name Time Method Self-Efficacy for Exercise Baseline, 3 months, and 6 months 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.
Harvard T.H. Chan School of Public Health Food Frequency Questionnaire for adults from 2007 Baseline, 3 months, and 6 months 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.
PROMIS 7-item Short Form - Fatigue Baseline, 3 months, and 6 months 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.
Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity survey Baseline, 3 months, and 6 months CHAMPS estimates total weekly energy expenditure (in kilocalories per week) from low to vigorous intensity physical activities for older adults.
Physical Activity Stage Assessment Baseline, 3 months, and 6 months This 5-question measure asks the person to select one description, from a choice of five, which describes his current activity behavior.
Charlson Comorbidity Index Baseline, 3 months, and 6 months The Charlson Comorbidity Index is a weighted index to predict mortality. Scores range from 0-37, with higher scores indicating more chronic medical conditions.
Self-Efficacy for Diet Baseline, 3 months, and 6 months 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.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Baseline, 3 months, and 6 months 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.
Pittsburgh Sleep Quality Index Baseline, 3 months, and 6 months 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.
Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Baseline, 3 months, and 6 months 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.
Behavioral Regulation in Exercise Questionnaire (BREQ2) Baseline, 3 months, and 6 months 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.
Trial Locations
- Locations (2)
UCSF Medical Center-Mount Zion
🇺🇸San Francisco, California, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States