A Technology-based Intervention for Promoting Physical Activity Among Post-treatment Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change in aerobic exercise behaviour (subjective measure)
研究概览
简要总结
Cancer survivors generally have low physical activity (PA) levels. While literature shows some evidence of improvement in PA following technology-based PA promotion interventions among cancer survivors, high-quality randomised control trials (RCTs), with objective measures of PA and longer-term follow-up, are lacking. Using a theoretical framework that addresses action control in addition to intention formation may enhance intervention effect. The Multi-process action control (M-PAC) framework is an extension of the traditional intention-formation theories, incorporating constructs that address the translation of intention into behaviour and continual action control. After comprehensively searching, no previous or ongoing RCTs have investigated the efficacy of a technology-based PA promotion intervention in cancer survivors that is designed based on the M-PAC framework. Investigators therefore propose a RCT to evaluate a technology-based intervention (WExercise) to support the promotion of PA in cancer survivors.
详细描述
Objective: To develop a technology-based physical activity promotion intervention (WExercise) for cancer survivors based on the Multi-process Action Control (M-PAC) Framework and examine its usability and efficacy.
Main hypothesis: The WExercise group will have a significantly greater increase in aerobic exercise than the self-directed exercise group at post-intervention.
Design: Phase 1- Application development; Phase 2- Usability testing (n=10); Phase 3- Assessor-blind two-arm randomized controlled trial (n=98; WExercise or self-directed exercise group).
Subjects: Physically inactive cancer survivors who have completed curative treatment.
Study instruments: Accelerometry, Godin Leisure Time Exercise Questionnaire, 6-minute walk test, EORTC QLQ-C30, M-PAC questionniare; administered at baseline, post-intervention, and 3 months post-intervention.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •completion of primary treatment (surgery/chemo-/radiation therapy) of curative intent for at least 12 months,
- •no metastasis, no recurrence
- •not meeting the recommended PA guideline (<150 min of moderate intensity aerobic exercise and <75 min of vigorous aerobic exercise per week)
- •access to Internet
- •able to read Chinese and communicate in Cantonese or Putonghua
- •screened by a nurse as no contraindications for engaging in unsupervised exercise using a risk screening tool
排除标准
- •have a psychiatric disorder
- •significant cognitive impairment
- •a history of more than one cancer
结局指标
主要结局
Change in aerobic exercise behaviour (subjective measure)
时间窗: Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23). Self-reported minutes of moderate-to-vigorous aerobic exercise will be recorded.
Measured by the Godin Leisure Time Exercise Questionnaire (Min and Max NA; higher scores represent higher aerobic exercise level)
Change in aerobic exercise behaviour (objective measure)
时间窗: Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23). Each time point will measure 7 full consecutive days and average time (minutes) per day spent in moderate-to-vigorous aerobic exercise will be reported.
Measured as time spent in moderate-to-vigorous aerobic exercise using accelerometer
次要结局
- Change in exercise capacity(Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).)
- Change in key components of M-PAC framework(Measure at Baseline (Week 0), Mid-intervention (Week 5), Post-intervention (Week 11), 3 months post-intervention (Week 23).)
- Change in cancer-specific Quality of life(Measure at Baseline (Week 0), Post-intervention (Week 11), 3 months post-intervention (Week 23).)
- Application usage(Measure at post-intervention (Week 11))
研究者
Cheung Shuk-Ting
Assistant Professor
The University of Hong Kong