School of Nursing, The University of Hong Kong
Hong Kong
NCT Number: NCT06003335
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hong Kong
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.
Reinforcement: Providing systematic feedback and positive validation on behavioral changes.
Hypotheses: We hypothesize that lung cancer survivors with CRCI receiving the personalized motivational messaging intervention will demonstrate (1) significantly greater improvements in objective and subjective cognitive function, and (2) significantly increased physical activity levels compared to those receiving standard care.
Randomization and Blinding: Participants will be randomly allocated to either the intervention or control arm. A computer-generated randomization sequence will be created by an independent statistician using block randomization with varying block sizes (blocks of 4, 6, and 8). Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Outcome assessors and the trial statistician will be blinded to group allocation.
Intervention Arm: Participants will be equipped with a wearable activity tracker for 3 months. They will receive personalized motivational messages from a comprehensive message library developed by an oncology specialist and a research nurse trained in motivational interviewing. The intervention features two components: (a) regular message delivery whose frequency and timing are tailored to participant preferences, and (b) interactive chat-type support facilitating goal setting, real-time counseling, and practical advice.
Control Arm: Participants will receive an informational leaflet containing basic CRCI education and standard text message reminders for follow-up assessments, without the personalized motivational or interactive chat components.
Data Collection & Analysis: Quantitative assessments will occur at baseline (T0), 3 months (T1), and 6 months (T2). An Intention-to-Treat (ITT) analysis will be performed. Generalized Estimating Equations (GEE) will be utilized to estimate between-group and within-group differences across time points, adjusting for baseline covariates. GEE robustly handles missing longitudinal data without manual imputation.
Economic & Qualitative Evaluation: A cost-effectiveness analysis will calculate the Incremental Cost-Effectiveness Ratio (ICER) using Quality-Adjusted Life Years (QALYs) derived from EORTC QLQ-C30 scores. Additionally, a post-trial qualitative study using purposive maximum variation sampling will conduct in-depth interviews (analyzed via 7-step thematic analysis in NVivo) to understand intervention compliance and participant experience.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Regular messages will be sent regularly to each participant over the 12-week study period. As personalisation is a core process in enabling behavioural change, the intervention content, frequency, and timing of the messages will be based on the participants' self-care needs and preferences, which will be surveyed at baseline. If no specific preferences are provided, we will plan the message delivery to decrease in frequency over time as this trend has shown the highest effectiveness in existing studies. The format of messages will be mainly texts, but other formats such as pictures and voice messages will also be considered for addition to the content library to suit a wide range of preferences.
Chat-based support will be given to the participants in addition to the regular message delivery. Instant messaging will be used to communicate directly with the participants. We plan to recruit 10 student RAs who have been trained in the delivery of interactive instant messages (IMs) to provide chat-type support to encourage increased physical activity and interaction. Participants will be invited to set physical activity goals and action plans through the chat-type support. Participants will receive a personalised summary of their physical activity weekly and will be encouraged to reflect on this through a real-time chat (around 5 minutes). They will also be encouraged to establish a plan of how they can adjust their physical activity goal going forward. When addressing the participants' queries or any ethical concerns, the student RAs will be instructed to immediately report to the Principal Applicant and supervisors who are experienced and trained research nurses.
Time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures objective cognitve function. It consists of 4 dimensions (attention, memory, language/executive function, and orientation). The total score ranges from a minimum of 0 to a maximum of 30. Higher scores indicate better cognitive function, while lower scores suggest cognitive decline or impairment. The categorization of subject scores are corrected by years of education and age.
Time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures subjective cognitve function and its impact on quality of life in cancer patients.
It has 4 dimensions. 1. Perceived Cognitive Impairments (PCI): Range 0-72. 2. Perceived Cognitive Abilities (PCA): Range 0-36. 3. Comments from Others (Oth): Range 0-16. 4. Impact on Quality of Life (QoL): Range 0-16. Because negatively worded items are reverse-scored, higher scores across all sub-dimensions mean better outcomes: fewer perceived impairments, better perceived abilities, fewer negative comments from others, and less negative impact on quality of life.
Time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures the level of physical activity undertaken by adults. It covers 4 dimensions: vigorous-intensity activities, moderate-intensity activities, walking, and sitting. The score is calculated as continuous MET-minutes/week. The minimum value is 0 MET-minutes/week, and the maximum value is theoretically unlimited. Higher scores indicate a higher volume and intensity of physical activity, meaning the individual is more physically active.
Time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures an individual's self-confidence in their ability to continue exercising despite facing various barriers (e.g., fatigue, bad weather, lack of time). It is unidimensional (1 dimension). The total score typically ranges from a minimum of 0 to a maximum of 70 (depending on the exact version used). Higher scores indicate greater self-efficacy, meaning the person has stronger confidence and belief in their ability to maintain a regular exercise routine.
Time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures the core symptoms of anxiety and depression. It consists of 2 dimensions: anxiety (2 items) and depression (2 items). The total score ranges from a minimum of 0 to a maximum of 12. Each individual dimension ranges from 0 to 6. Higher scores indicate a higher burden of psychological distress, meaning the patient is experiencing more frequent or severe symptoms of anxiety and depression.
Time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures the health-related quality of life of cancer patients. It has 15 dimensions. All scores are linearly transformed to a range of 0 to 100. 1. Global Health Status/QoL (1 dimension): Range 0-100. Higher scores mean better overall health and quality of life. 2. Functional scales (5 dimensions: physical, role, emotional, cognitive, social): Range 0-100. Higher scores mean a higher/healthier level of functioning. 3. Symptom scales/items (9 dimensions: fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties): Range 0-100. Higher scores mean worse outcomes, indicating more severe symptoms or problems.
The University of Hong Kong
Other
Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors With Cancer-related Cognitive Impairment: a Randomised Controlled Trial
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