NCT06003335

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

June 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

August 15, 2023

Last Update Submit

June 2, 2026

Conditions

Keywords

mHealthphysical activitycancer related cognitive impairmentlung cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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)

Secondary Outcomes (4)

  • International Physical Activity Questionnaire-Short Form

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

  • Exercise Self-efficacy Scale

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

  • Patient Health Questionnaire 4 item

    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

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

Study Arms (3)

Motivational Personalized Messaging + Regular Health Education

EXPERIMENTAL

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.

Behavioral: Regular message of health educationBehavioral: Chat-type motivational personalized messaging support

Regular Health Education

ACTIVE COMPARATOR

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.

Behavioral: Regular message of health education

Self-management

NO INTERVENTION

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.

Interventions

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.

Motivational Personalized Messaging + Regular Health EducationRegular Health Education

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.

Motivational Personalized Messaging + Regular Health Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

Related Publications (2)

  • 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.

    PMID: 40071688BACKGROUND
  • 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.

MeSH Terms

Conditions

Lung NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 21, 2023

Study Start

February 1, 2024

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

June 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations