Повышение физической активности с помощью персонализированных мотивационных сообщений для улучшения когнитивных функций у выживших после рака легких
Повышение физической активности с помощью персонализированных мотивационных сообщений для улучшения когнитивных функций у выживших после рака легких с когнитивными нарушениями, связанными с раком: рандомизированное контролируемое исследование
Цели: изучить эффективность персонализированного вмешательства по обмену мотивационными сообщениями для улучшения когнитивных функций у выживших после рака легких.
Гипотеза для проверки: выжившие после рака легких, получающие персонализированные мотивационные сообщения, будут иметь лучшие когнитивные функции, чем обычное лечение.
Дизайн и субъекты: рандомизированное контролируемое исследование с участием 196 выживших после рака легких с когнитивными нарушениями, связанными с раком.
Вмешательство: группа вмешательства будет оснащена носимым трекером активности на 3 месяца и будет получать персонализированные мотивационные сообщения через приложения для обмена мгновенными сообщениями (например, WhatsApp) для пропаганды физических упражнений. Вмешательство будет включать 1) регулярные сообщения, отправляемые в предпочтительное время и с определенной частотой, позволяющие участникам выбирать предлагаемые цели физической активности, и 2) поддержку посредством сообщений в чате, таких как постановка целей, консультирование в режиме реального времени и практические советы. Контрольная группа получит листовку о когнитивных нарушениях с текстовыми сообщениями-напоминаниями для последующих обследований.
Основные показатели результатов: данные будут собираться на исходном уровне (T0), через 3 месяца (T1; сразу после проведения вмешательства) и через 6 месяцев (T2; долгосрочное наблюдение). Первичным результатом будет когнитивная функция, измеренная по шкале HK-MoCA (объективная) и по шкале функциональной оценки когнитивной функции терапии рака (FACT-Cog) (субъективная). Вторичными результатами являются физическая активность (IPAQ-SF), самоэффективность при выполнении упражнений (SEE), психологическое благополучие (PHQ-4) и качество жизни (EORTC QLQ-C30).
Анализ данных: Будут проведены анализ намерения лечить, качественный анализ после исследования (соблюдение режима вмешательства) и анализ экономической эффективности. Мы будем следовать контрольному списку CONSORT-EHEALTH.
Ожидаемые результаты: Это исследование предоставит доказательства эффективности предлагаемого вмешательства в улучшении когнитивных функций и увеличении физической активности среди выживших после рака легких.
Обзор исследования
Статус
Подробное описание
- 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.
Reinforcement: Providing systematic feedback and positive validation on behavioral changes.
- Objectives The primary objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of an SCT-based, personalized motivational messaging intervention delivered via an instant messaging application in improving cognitive function among lung cancer survivors with CRCI. The secondary objectives are to assess the intervention's impact on physical activity levels, exercise self-efficacy, psychological well-being, and health-related quality of life, as well as to evaluate the cost-effectiveness and participants' qualitative experiences of the intervention.
Main Research Questions and Hypotheses Research Question: Does a personalized motivational messaging intervention, utilizing wearable activity trackers and real-time IM support, effectively mitigate cognitive decline and promote physical activity in lung cancer survivors compared to standard care?
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.
Study Design and Methods This study is a randomized controlled trial (RCT) comprising 124 lung cancer survivors, augmented by a post-trial qualitative process evaluation.
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.
- Expected Outcomes The trial is expected to yield robust quantitative evidence that personalized EMI significantly improves cognitive domains (such as attention, verbal learning, and executive function) and sustains moderate-to-vigorous physical activity in lung cancer survivors. Furthermore, the trial is expected to demonstrate high feasibility, user acceptability, and cost-effectiveness compared to standard oncological supportive care.
- Significance of the Study This study addresses a critical gap in cancer survivorship by targeting CRCI-a prevalent but frequently overlooked symptom. If proven effective, this intervention provides an efficient, highly scalable, real-world, and cost-effective digital health solution. Furthermore, the chat-log data and user preference profiles generated from this study will establish a foundational database for the future development of Artificial Intelligence (AI) chatbot services for physical activity management, aligning with global smart-city healthcare blueprints and advancing the implementation science of mHealth in oncology.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Hong Kong
-
Hong Kong, Hong Kong, Гонконг
- School of Nursing, The University of Hong Kong
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Критерии включения:
- в возрасте ≥ 18 лет;
- диагностирован неметастатический рак I-III стадии НМРЛ;
- завершено первичное лечение с целью излечения (хирургическое вмешательство, химиотерапия и/или лучевая терапия) за период от 6 месяцев до 5 лет до исходной оценки без рецидива или появления дополнительных раковых заболеваний;
- согласно 5-минутному протоколу HK-MoCA (≤ 7-го процентиля с поправкой на возраст и образование);
- не занимается регулярными физическими упражнениями (определяется как < 150 минут упражнений средней интенсивности в неделю).
Критерий исключения:
- недостаточное чтение и устное понимание кантонского диалекта для учебной деятельности;
- диагностирована деменция;
- не может использовать приложения для обмена текстовыми сообщениями на мобильном телефоне (например, WhatsApp).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Motivational Personalized Messaging + Regular Health Education
The intervention group will receive personalised motivational messages (according to their physical activity levels and preferences screened during the baseline measurement) using instant messaging applications (e.g., WhatsApp).
They will be equipped with a wearable activity tracker for 3 months to monitor their physical activity level.
In accordance with the guidelines for mobile instant messageing development, we will develop a message content library and protocol for intervention delivery.
|
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.
|
|
Активный компаратор: Regular Health Education
Control group 1 will receive regular message delivery (as mentioned in the intervention) without personalised motivational messaging for better evaluation of the effect of personalized motivational messaging.
|
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.
|
|
Без вмешательства: Self-management
Control group 2 (self-management) will only receive a leaflet containing basic information about CRCI distributed during the recruitment process and text message reminders for follow-up surveys.
Regular and real-time support (i.e., chat-type) messages will not be made available to the control group.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Hong Kong Montreal Cognitive Assessment
Временное ограничение: 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.
|
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
|
|
Functional Assessment of Cancer Therapy-Cognitive Function
Временное ограничение: 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. |
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
International Physical Activity Questionnaire-Short Form
Временное ограничение: 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.
|
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
|
|
Exercise Self-efficacy Scale
Временное ограничение: 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.
|
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
|
|
Patient Health Questionnaire 4 item
Временное ограничение: 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.
|
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
Временное ограничение: 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.
|
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Ho MH, Wang L, Wong JWH, Xin G, Zhang Q, Lin YK, Cheung DST, Vardy JL, Lin CC. Comparative effectiveness of various nonpharmacological interventions, including traditional Chinese medicine-based interventions for cancer-related cognitive impairment: a comprehensive network meta-analysis. J Natl Cancer Inst. 2025 Sep 1;117(9):1784-1796. doi: 10.1093/jnci/djaf059.
- Ho MH, Cheung DST, Tan JB, Lin CC. Ecological Momentary Mobile Cognitive Screening for Cancer-Related Cognitive Impairment Among Patients With Lung Cancer. Cancer Nurs. 2025 Jul 24. doi: 10.1097/NCC.0000000000001530. Online ahead of print.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- uhongkongc9ttii37
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .