Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors With Cancer-related Cognitive Impairment: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
研究概览
简要总结
Objective: To evaluate the effectiveness of a personalized motivational messaging intervention designed to improve cognitive function in lung cancer survivors.
Hypothesis: Lung cancer survivors who receive personalized motivational messaging will demonstrate significantly greater improvements in cognitive function compared to those receiving standard care.
Design and Participants: A randomized controlled trial (RCT) comprising 196 lung cancer survivors experiencing cancer-related cognitive impairment.
Intervention: Participants in the intervention arm will be provided with a wearable activity tracker for three months and will receive personalized motivational messages via instant messaging applications (e.g., WhatsApp) to promote physical activity. The intervention comprises: (1) regular messages delivered at participant-preferred times and frequencies, enabling individuals to select from suggested physical activity goals; and (2) interactive, chat-based support facilitating goal setting, real-time counseling, and practical advice. The control group will receive an informational leaflet on cognitive impairment, along with text message reminders for follow-up assessments.
Main Outcome Measures: Data collection will occur at baseline (T0), three months (T1; immediately post-intervention), and six months (T2; long-term follow-up). The primary outcome is cognitive function, assessed objectively via the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) and subjectively via the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale. Secondary outcomes include physical activity levels (IPAQ-SF), exercise self-efficacy (SEE), psychological well-being (PHQ-4), and health-related quality of life (EORTC QLQ-C30).
Data Analysis: Quantitative data will be analyzed using an intention-to-treat approach. Additionally, post-trial qualitative evaluations (to assess intervention compliance) and cost-effectiveness analyses will be performed. The study will strictly adhere to the CONSORT-EHEALTH reporting guidelines.
Expected Outcomes: This trial will provide robust evidence regarding the effectiveness of the proposed intervention in mitigating cognitive impairment and increasing physical activity levels among lung cancer survivors.
详细描述
- Background of the Research Project Lung cancer is a leading cause of cancer-related mortality worldwide. In Hong Kong, it accounts for over 26% of all cancer deaths, with 80% to 85% being non-small cell lung cancers (NSCLC). While cancer-related symptoms affecting overall survival and quality of life have been extensively studied, cancer-related cognitive impairment (CRCI) remains a critical yet under-researched complication. CRCI refers to cognitive dysfunction, including impaired working or short-term memory, inattention, disorientation, and declines in executive function, language comprehension, and processing speed. More than 50% of patients with non-central nervous system (CNS) cancers present with CRCI after primary treatments. Our preliminary pilot data indicated that the prevalence of cognitive impairment in attention and memory among lung cancer patients was 35.4% and 58.4%, respectively. CRCI significantly impacts patients' functional independence and can lead to anxiety, depression, and sleep disorders, highlighting an urgent need for effective, accessible interventions.
- Theoretical and Clinical Background Clinically, several studies and systematic reviews have demonstrated that exercise and physical activity interventions can alleviate CRCI in cancer patients. However, traditional exercise programs often suffer from poor long-term adherence and a lack of sustained motivation once the formal intervention period ends. To address this translational gap, this study utilizes an Ecological Momentary Intervention (EMI) approach via mobile health (mHealth) technology. EMI delivers health interventions through instant messaging (IM) applications (e.g., WhatsApp) in a personalized, real-time, and in-situ format.
Theoretically, the intervention is rigorously grounded in Social Cognitive Theory (SCT), which posits that personal and environmental factors influence health behaviors. The intervention design operationalizes key SCT constructs:
Behavioral Capability: Providing tailored information to increase physical activity based on self-care needs.
Outcome Expectations: Educating participants on how physical activity improves neurocognitive function.
Observational Learning: Utilizing case vignettes of other survivors. Self-efficacy: Fostering belief in behavioral change through collaborative goal-setting and chat-based support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, 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
- •aged ≥ 18 years;
- •diagnosed with stage I-III non-metastatic NSCLC cancer;
- •completed primary treatment with curative intent (surgery, chemotherapy and/or radiation therapy) 6 months to 5 years prior to the baseline assessment with no recurrence or occurrence of additional cancers;
- •identified as having mild cognitive impairment by the HK-MoCA 5-Min Protocol (≤ 7th age- and education-corrected percentile cut-off score);
- •not engaged in regular exercise (defined as < 150 min of moderate-intensity exercise per week).
排除标准
- •inadequate reading and verbal Cantonese comprehension for the study activities;
- •diagnosed with dementia;
- •unable to use mobile phone text messaging applications (e.g., WhatsApp).
结局指标
主要结局
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
时间窗: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Primary outcome: subjective cognitve function
Hong Kong Montreal Cognitive Assessment (HK-MoCA)
时间窗: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Primary outcome: objective cognitve function
次要结局
- Self-efficacy for exercise (SEE)(at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up))
- Patient Health Questionnaire 4 item (PHQ-4)(at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up))
- International Physical Activity Questionnaire-Short Form (IPAQ-SF)(at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up))
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up))