Randomized Controlled Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors: The OutPACE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Objectively Measured Physical Activity
研究概览
简要总结
This trial is a three-armed randomized controlled trial which will explore the utility of an implementation intention intervention on aerobic and resistance exercise in older (60+) prostate and breast cancer survivors and improving quality of life. It is expected that those in the experimental groups will report greater increases in their physical activity, resulting in greater improvements in their quality of life.
详细描述
Recruitment
Potential participants will be contacted by the Newfoundland and Labrador Cancer registry. They will be given a brief explanation of the study will be asked to consent to a mail-out questionnaire from the registry. The questionnaire will contain a cover letter explaining the study in more detail along with informed consent. If the participant wishes to continue in the study, they will return the questionnaire to the research team, who will contact them from this point.
Participants will also be recruited through presentations at local support groups as well as advertisements in local papers and posters at local hospitals and recreation centers.
Power Analysis
According to G*Power a sample of 40 prostate and breast cancer survivors per group (n=120) is needed to detect a medium effect size (d= .50) on our primary outcome (i.e., PA) with a power of 0.80, at a p-level of 0.05. We expect a 20% attrition rate, based on previous research (McGowan, North, & Courneya, 2013; Vallance, Courneya, Plotnikoff, Yasui, & Mackey, 2007) therefore we will attempt to recruit a sample of 150 breast and prostate cancer survivors, which would allow for 50 participants per group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60 years old or older
- •Breast or prostate cancer survivor
- •Completed surgery, radiation and/or chemotherapy
- •Proficient in English
- •Living in the greater St. John's, NL area; participants are asked to meet researchers at the university
- •Have an interest in becoming more active or learning about physical activity
排除标准
- •Those with contraindications to exercise
- •Participants will be asked about other existing diseases and if they have been told by their doctor to avoid certain activities. Some may be asked to consult with physician before taking part
研究组 & 干预措施
Two-time implementation intention
Group will receive physical activity materials along with the implementation intention intervention and a booster again six weeks following.
干预措施: Two-time implementation intention (Behavioral)
Two-time implementation intention
Group will receive physical activity materials along with the implementation intention intervention and a booster again six weeks following.
干预措施: Physical Activity Materials (Behavioral)
One-time implementation intention
Group will receive physical activity materials along with the implementation intention intervention.
干预措施: One-time implementation intention (Behavioral)
One-time implementation intention
Group will receive physical activity materials along with the implementation intention intervention.
干预措施: Physical Activity Materials (Behavioral)
Sham Comparator Group
Group will receive Canada's Food Guide which contains a small amount of physical activity information.
干预措施: Sham Comparator (Behavioral)
结局指标
主要结局
Change in Objectively Measured Physical Activity
时间窗: Baseline, one month follow-up, three month follow-up
Participants will wear an accelerometer (ActiGraph GT3X) for seven days to assess their activity. Data from each time point will be analyzed and compared to determine change.
Change in Self-Reported Physical Activity
时间窗: Baseline, one month follow-up, three month follow-up
Using Godin's Leisure Score Index, participants will be asked how much physical activity they took part in over the past seven days. Data from each time point will be analyzed and compared to determine change.
次要结局
- Change in Fatigue(Baseline, one month follow-up, three month follow-up)
- Change in Quality of Life(Baseline, one month follow-up, three month follow-up)
研究者
Erin McGowan
Assistant Professor
Memorial University of Newfoundland