Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Completion Rate
研究概览
简要总结
The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.
详细描述
The investigators aim to conduct a trial examining the feasibility and the effects of a combined pelvic health rehabilitation and exercise program that can be delivered both in-person and virtually in individuals who have been treated with prostatectomy for prostate cancer. This hybrid format will support equitable program delivery regardless of location of residence. To address issues faced by men with prostate cancer, the investigators propose an intervention (offered virtually and in-person) that includes: 1) online education to support continence, sexual and overall health; 2) a group exercise fitness program that considers the needs and restrictions specific to the early post-prostatectomy surgical period, and 3) functional and intensive pelvic floor muscle exercise retraining to promote continence and sexual recovery.
Main objectives of this study
- Determine the feasibility, defined as the acceptability and appropriateness, of a combined pelvic health rehabilitation and exercise fitness program that can be delivered both in-person and virtually.
- Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care.
Secondary objectives of this study
- To determine the effects of the program on cardiometabolic indicators in comparison with usual care.
- To determine the effects of the program on general fitness, secondary outcomes of urinary continence, sexual function, self-efficacy, and cancer symptom burden, in comparison with usual care.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants will be randomized after the baseline assessment and will have the option to take part in an additional exercise intervention component.
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
- •have a diagnosis of prostate cancer (stage I to IV);
- •be scheduled for a prostatectomy surgery (any surgical approach);
- •have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+);
- •speak and understand English.
- •adult: 18 years of age or older
- •optional exercise component: willing and able to commit to the 12-week intervention
排除标准
- •have any medical conditions that may interfere with continence (i.e. neurological diseases);
- •have any contraindications to exercise testing or training;
- •have recent (>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric);
- •do not have regular access to the internet and a smart device or a computer at home/ at their community center;
- •are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.
研究组 & 干预措施
Intervention
Pelvic floor exercise program and general exercise programming
干预措施: Pelvic floor exercise program (Behavioral)
Intervention
Pelvic floor exercise program and general exercise programming
干预措施: General exercise (Behavioral)
Control
Pelvic floor exercises and standard care (physical activity counseling)
干预措施: Pelvic floor exercise program (Behavioral)
Control
Pelvic floor exercises and standard care (physical activity counseling)
干预措施: Physical Activity Counseling (Behavioral)
结局指标
主要结局
Completion Rate
时间窗: Final assessment at one year
The number of participants completing the study including all planned outcomes
次要结局
- Lower body strength(12-weeks)
- Balance(12-weeks)
- Flexibility(12-weeks)
- Lipid profile(12-weeks)
- Walking endurance(12-weeks)
- Upper limb mobility(12 weeks)
- Self-efficacy Questionnaire: Incontinence(One year)
- Adherence rate(Post-intervention: 12 weeks)
- International Consultation on Incontinence Questionnaire(One-year)
- Edmonton Symptom Assessment Scale(One year)
- Expanded Prostate Cancer Index Composite for Clinical Practice(One-year)
- Glucose(12-weeks)
- Recruitment rate(One year)
- 24-hour pad test(24 hours at two time points: immediate post surgery and 12 weeks)
- 36-Item Short Form Survey(One-year)
- Grip Strength(12 weeks)
- Body Mass Index(12-weeks)
- Insulin level(12-weeks)
- Hemoglobin A1c(12-weeks)