A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Proportion of patients with detectable levels of Prostate-specific antigen (PSA)
研究概览
简要总结
The Prostate 8-II study is a randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To examine the effects of 2-year exercise and/or diet interventions on time to prostate-specific antigen (PSA) recurrence after RP.
SECONDARY OBJECTIVES:
I. Assess the proportion of participants with PSA recurrence at 6-, 12-and 24-months post-surgery.
II. To examine quality of life (QOL) across intervention groups over time. Outcomes will include sexual and urinary function, anxiety, depression, and overall QOL assessed at all timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age >=18 years
- •Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
- •Able to speak and read English
- •Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
- •Ability to understand a written informed consent document, and the willingness to sign it
排除标准
- •Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling >4 weeks prior to RP).
- •Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria (https://www.ncbi.nlm.nih.gov/pubmed/26473759), and who do not receive a physician clearance to participate in the moderate to vigorous 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
- •Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session
- •Men who are already meeting all of the 7 prostate-specific dietary recommendations
研究组 & 干预措施
Arm A: Reference Group
Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 10-week text messaging program focused on recovery after radical prostatectomy surgery.
干预措施: Exercise and Diet (Behavioral)
Arm B (Arm A + Exercise)
Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.
干预措施: Exercise and Diet (Behavioral)
Arm C (Arm A + Diet)
Arm C receives the following: Arm A material plus access to an online portal with additional educational materials to help improve diet habits and various tools, such as the ability to track diet; additional educational print materials on diet; additional text messages over 2 years that supports healthy diet habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
干预措施: Exercise and Diet (Behavioral)
Arm D (Arm A + Exercise + Diet)
Arm D receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise and diet habits and various tools, such as the ability to track exercise and diet; additional educational print materials on exercise and diet; additional text messages over 2 years that supports healthy exercise and diet habits; a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
干预措施: Exercise and Diet (Behavioral)
结局指标
主要结局
Proportion of patients with detectable levels of Prostate-specific antigen (PSA)
时间窗: 6 months and 24 months post-surgery
Detectable PSA will be defined based on current practice at the time of analysis. Point estimate and 95% confidence interval of the proportion of detectable PSA at 6 months and 2 years post-surgery for each group will be reported. In addition, Pearson's Chi-square test will be used to test if there are differences in the proportion of detectable PSA at least 6 weeks post-surgery among the groups. If there is a significant difference observed, a 2-sample proportion test to compare Groups B, C, and D, separately, with Group A and one another for each post-intervention time point will be performed. Point estimates and 95% confidence intervals of the recurrence proportion will be obtained for each group
Annual PSA recurrence rate
时间窗: Up to 5 years
Risk of cancer recurrence (based on current practice) measured using standard criteria using a log- rank test to evaluate the time to recurrence among groups, and multivariate Cox proportional hazards regression to obtain a hazard ratio for the time to recurrence
Median Time to prostate-specific antigen recurrence
时间窗: Up to 5 years post-surgery
The median time in months to PSA recurrence after surgery will be evaluated using prespecified biochemical recurrence (2x PSA ≥ 0.2) and detectable (2x PSA ≥ 0.03) PSA thresholds, at the time of analysis. A log-rank test to evaluate the time to recurrence among groups and multivariate Cox proportional hazards regression will be used to obtain a hazard ratio for the time to recurrence.
次要结局
- Change in scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Change in urinary function as measured by the EPIC-26(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Change in scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS)(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Change in scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Change in scores on the SF-12(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Change in physical activity over time(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Change in Harvard Food Frequency Questionnaire (FFQ) over time(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Intervention feasibility and acceptability (intervention arms)(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Self/efficacy confidence in adopting healthy behaviors over time(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Changes in Messenger Ribonucleic Acid (mRNA) expression patterns (focusing on change between biopsy and RP)(From baseline to up to 8 weeks)
- Decipher score (focusing on change between biopsy and RP)(From baseline to up to 8 weeks)
- Change in scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Change in sexual function as measured by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26)(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Diet recall(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Changes in perceived social support(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Changes in scores on the Pittsburgh Sleep Quality Index (PSQI)(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Proportion of participants with PSA recurrence over time(Up to 24 months post-surgery)
- Mean scores on the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores on the urinary function domain of the EPIC-26 over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores on the 12-Item Short Form Health Survey (SF-12) over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Changes in recorded physical activity over time(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores in Harvard Food Frequency Questionnaire (FFQ) over time(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Frequency of responses on the Intervention feasibility (intervention arms)(Baseline, and 6 months, 12 months, and 24 months post-surgery)
- Mean scores on the Pittsburgh Sleep Quality Index (PSQI) over time.(Baseline, and 6 months, 12 months, and 24 months post-surgery)