Improving Quality of Life in Hematologic Cancer Survivors by Closing the Exercise Intention-Behavior Gap: a Phase II Randomized Controlled Trial of a Theory-based, Telephone-delivered Exercise Counselling Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change from baseline in Exercise Levels
研究概览
简要总结
This study evaluates the impact of a 12-week theory-based exercise telephone counselling program (versus a self-directed exercise group) on closing the exercise intention-behavior gap in a sample of hematologic cancer survivors.
详细描述
Problem: Regular exercise participation improves quality of life and physical function for cancer survivors. Unfortunately, the most effective way of promoting exercise to cancer survivors has yet to be determined, and as a result, many survivors are inactive. Theory-based efforts have typically focused on promoting intentions to exercise, though we are now discovering that only about half of those who intend to exercise actually follow through on their intentions. This is known as the exercise intention-behavior gap. It also appears that survivors are more likely to follow-through on their intention to exercise when they report employing key behavioral and motivational strategies (i.e., creating detailed exercise plans, feeling capable and obligated to exercise, perceiving it to be beneficial and fun, and avoiding the temptation to participate in alternative activities) which may be promoted via telephone counselling.
Objective
To determine whether a theory-based telephone counselling intervention focused on closing the exercise intention-behavior gap is feasible and can improve exercise levels, motivation, quality of life, and fatigue in hematologic cancer survivors.
Methods: A two-armed randomized controlled trial will compare the efficacy of telephone counselling versus a control condition (self-directed with Canada's Physical Activity Guide). All participants will be asked to increase their exercise by at least 60 minutes per week. Hematologic cancer survivors who previously participated in an exercise survey study and indicated interest in participating in future exercise related research (N=407) will be contacted to participate in the current trial. Eligible participants will be randomized in a 1:1 ratio to either the telephone counseling group or a self-directed exercise group. Participants in the intervention arm will receive 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention. A sample of approximately N=66 hematologic cancer survivors will be recruited for this 12-week trial. Data will be collected via online surveys assessing changes in exercise levels, motivation, quality of life, and fatigue. Feasibility will be determined by eligibility percentage, recruitment percentage, adherence rate, assessment completion rate, adverse events, and ratings of program acceptability.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for this study will be survivors who have had a histologically confirmed hematologic cancer, and who are between 18-80 years of age, living in Alberta, can speak and comprehend English, and willing to participate in a 12-week exercise telephone counseling intervention.
排除标准
- •Survivors reporting greater or equal to 150 minutes of moderate-to-vigorous exercise will be excluded because they will already be meeting the public health guidelines for exercise. Survivors planning to be away for more than 2 weeks during the intervention, or with major exercise contraindications will also be excluded.
研究组 & 干预措施
Telephone Counselling
Participants will be asked to increase their exercise by at least 60 minutes per week and will receive a copy of Canada's Physical Activity Guideline plus 12 weekly telephone counseling sessions aimed at helping survivors follow-through on their exercise intention.
干预措施: Telephone counselling (Behavioral)
Control
Participants will be asked to increase their exercise by at least 60 minutes per week and will be self-directed, only receiving a copy of Canada's Physical Activity Guideline as standard of care.
结局指标
主要结局
Change from baseline in Exercise Levels
时间窗: Baseline and within 7 days of completing the 12-week intervention
Exercise levels assessed using the Godin Leisure-Time Exercise Questionnaire
次要结局
- Change from baseline in Quality of life(Baseline and within 7 days of completing the 12-week intervention)
- Change from baseline in Fatigue(Baseline and within 7 days of completing the 12-week intervention)
- Change from baseline in Exercise Motivation(Baseline and within 7 days of completing the 12-week intervention)
研究者
Kerry Courneya
Principal Investigator
University of Alberta