True NTH Community of Wellness Internet-Based Exercise and Diet Support for Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Group I
Written Information
干预措施: Written Information (Behavioral)
Group II
Written Information Prescription
干预措施: Written Information (Behavioral)
Group II
Written Information Prescription
干预措施: Prescription (Behavioral)
Group III
Written Information Prescription Technology
干预措施: Written Information (Behavioral)
Group III
Written Information Prescription Technology
干预措施: Prescription (Behavioral)
Group III
Written Information Prescription Technology
干预措施: Technology (Behavioral)
Group IV
Written Information Prescription Technology Coaching
干预措施: Written Information (Behavioral)
Group IV
Written Information Prescription Technology Coaching
干预措施: Prescription (Behavioral)
Group IV
Written Information Prescription Technology Coaching
干预措施: Technology (Behavioral)
Group IV
Written Information Prescription Technology Coaching
干预措施: Coaching (Behavioral)
结局指标
主要结局
Retention
时间窗: 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
时间窗: Up to 3 months
Measured as the # of times that a man visits the portal over three months
Accrual success
时间窗: Up to 3 months
Measured as ability to recruit target sample size within one year
次要结局
- Self-Efficacy for Exercise(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)
- PROMIS 7-item Short Form - Fatigue(Baseline, 3 months, and 6 months)
- Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity survey(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)
- Self-Efficacy for Diet(Baseline, 3 months, and 6 months)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(Baseline, 3 months, and 6 months)
- Pittsburgh Sleep Quality Index(Baseline, 3 months, and 6 months)
- Memorial Anxiety Scale for Prostate Cancer (MAX-PC)(Baseline, 3 months, and 6 months)
- Behavioral Regulation in Exercise Questionnaire (BREQ2)(Baseline, 3 months, and 6 months)
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute