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Lung CancerNCT06003335

Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors

A study testing Regular message of health education and Chat-type motivational personalized messaging support in people with Lung Cancer and Cancer-related Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Regular message of health education and Chat-type motivational personalized messaging support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteHong Kong
Study dates
1 Feb 2024to 31 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • inadequate reading and verbal Cantonese comprehension for the study activities;
  • diagnosed with dementia;
  • unable to use mobile phone text messaging applications (e.g., WhatsApp).

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • School of Nursing, The University of Hong Kong

    Hong Kong, Hong Kong

Other trials in Hong Kong

About this study

Official title: Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors With Cancer-related Cognitive Impairment: a Randomised Controlled Trial

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.

Read more

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.

Read the detailed description
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
Being tested
Regular message of health education, Chat-type motivational personalized messaging support
Keywords
mHealth, physical activity, cancer related cognitive impairment, lung cancer
Medical subject headings
Lung Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular message of health educationBehavioural

    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-type motivational personalized messaging supportBehavioural

    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.

Study groups in NCT06003335
Study groupRoleWhat they receive
Motivational Personalized Messaging + Regular Health EducationExperimentalThe 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.
Receives: Behavioral: Regular message of health education; Behavioral: Chat-type motivational personalized messaging support
Regular Health EducationActive comparatorControl 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.
Receives: Behavioral: Regular message of health education
Self-managementNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hong Kong Montreal Cognitive Assessment

    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.

    Measured: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

  2. Functional Assessment of Cancer Therapy-Cognitive Function

    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.

    Measured: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

Secondary outcomes (4)
  1. International Physical Activity Questionnaire-Short Form

    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.

    Measured: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

  2. Exercise Self-efficacy Scale

    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.

    Measured: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

  3. Patient Health Questionnaire 4 item

    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.

    Measured: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

  4. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire

    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.

    Measured: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start1 Feb 2024
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06003335
Sponsor's protocol ID
uhongkongc9ttii37
Status last verified
Mar 2026
First submitted
15 Aug 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40071688
  • 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.

    PubMed 40711466

Questions about this trial

What is this clinical trial studying?

A study testing Regular message of health education and Chat-type motivational personalized messaging support in people with Lung Cancer and Cancer-related Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hong Kong Montreal Cognitive Assessment (time frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06003335, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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