Effectiveness of Community-based Football Compared With Usual Care on Quality of Life in Men With Prostate Cancer: the FC Prostate Community Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 8
- 主要终点
- Mean change in quality of life from baseline to week 12
研究概览
简要总结
Prostate cancer is the most common malignancy in men. Three million are currently living in the United States with the disease and this number is expected to rise to four million in 2024. Most live many years with the disease and experience significant morbidity both due to disease progression and treatment toxicity. Exercise has shown to improve QoL and reduce treatment toxicity. Moreover epidemiological evidence has suggested that physical activity improves survival.
Football has been shown to induce positive effects on body composition and bone markers in a subgroup of prostate cancer patients, those receiving androgen deprivation therapy.
The objective is to examine the effectiveness of football in prostate cancer survivors.
详细描述
PLAN FOR THE STATISTICAL ANALYSES
This plan has been prepared and is laid forward before any follow-ups are conducted. The plan delineates the analyses of the FC PC trial; any deviations will be laid forward and discussed in the final publication.
The primary statistical analysis targets the effect on prostate cancer (PCa) specific Quality of Life (QoL) of a treatment policy offering community based football to men with prostate cancer. In particular, patients will be analysed in the treatment group to which they were randomly allocated respecting the intention-to-treat principle (ITT). The appropriate method for addressing this effect depends on the assumptions made about missing data (drop-outs). Our main analysis is valid under the missing at random assumption but we will also present sensitivity analyses robust to non-ignorable patterns among patients with incomplete data.
Per protocol analyses will be performed to estimate the de jure effect of the treatment for compliant patients. The "per protocol" population will be defined as those trial participants from the intervention group that have attended the football intervention at least 12 times in the first 12 weeks and 24 times in 6 months intervention period.
Significance tests will be two-sided with a maximal type I error risk of 5 %. To address the problem of multiple comparisons for secondary analyses when several outcomes are tested or multiple constracts are extracted from the same statistical model p-values will be adjusted using the step-down Bonferrroni method of Holm (Holm 1979) or appropriate modern alternatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Diagnosed with prostate cancer
- •Age ≥18 years
- •Able to read and understand questionnaires in Danish
- •Signed informed consent
排除标准
- •<6 weeks after prostatectomy
- •Football training disencouraged by primary physician
- •Osteoporosis (T-score < -2,5) assessed by Dual Energy X-Ray Absorptiometry at baseline
研究组 & 干预措施
Football
Recreational football 1-hour twice weekly in a local football club on a disease specific team
干预措施: Football (Behavioral)
Control
A 15-30-minute guidance session upon group allocation to encourage engagement in the standard rehabilitation offered by the municipality
结局指标
主要结局
Mean change in quality of life from baseline to week 12
时间窗: 12 weeks
Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire
次要结局
- Mean change in quality of life from baseline to month 6(6 months)
- Whole-body bone mineral content percent change from baseline to month 6(6 months)
- Whole-body fat mass mean change from baseline to month 6(6 months)
- Self-reported physical activity from baseline to week 12 and month 6(12 weeks and 6 months)
- Self-reported functional well-being from baseline to week 12 and month 6(12 weeks and 6 months)
- Whole-body bone mineral density percent change from baseline to month 6(6 months)
- Whole-body lean body mass mean change from baseline to month 6(6 months)
- Lumbar spine bone mineral density percent change from baseline to month 6(6 months)
- Femoral neck bone mineral density percent change from baseline to month 6(6 months)
- Total hip bone mineral density percent change from baseline to month 6(6 months)
- Number of participants with any fracture from baseline to month 6(6 months)
- Number of participants with falls that resulted in seeking medical assessment from baseline to month 6(6 months)
研究者
Eik Bjerre
Msc. PhD. Student
Rigshospitalet, Denmark