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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06003335
• Other study ID #: uhongkongc9ttii37
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: August 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives: To examine the effectiveness of a personalised motivational messaging intervention for improving cognitive function in lung cancer survivors. Hypothesis to be tested: Lung cancer survivors receiving personalised motivational messaging will have better cognitive function than usual care. Design and subjects: A randomised controlled trial in 196 lung cancer survivors with cancer-related cognitive impairment. Intervention: The intervention group will be equipped with a wearable activity tracker for 3 months and receive personalised motivational messages via instant messaging applications (e.g., WhatsApp) to promote physical exercise. The intervention will include 1) regular messages sent at preferred times and frequencies allowing participants to choose suggested physical activity goals, and 2) support via chat-type messaging such as goal setting, real-time counselling, and practical advice. The control group will receive a leaflet on cognitive impairment with reminder text messages for follow-up surveys. Main outcome measures: Data will be conducted at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up). Primary outcome will be cognitive function measured by HK-MoCA (objective) and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale (subjective). Secondary outcomes are physical activity (IPAQ-SF), self-efficacy for exercise (SEE), psychological well-being (PHQ-4), and quality of life (EORTC QLQ-C30). Data analysis: Intention-to-treat, post-trial qualitative (compliance with the intervention), and cost-effectiveness analyses will be conducted. We will follow the CONSORT-EHEALTH checklist. Expected results: This trial will provide evidence on the effectiveness of the proposed intervention on improving cognitive function and increasing physical activity among lung cancer survivors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged = 18 years;

2. diagnosed with stage I-III non-metastatic NSCLC cancer;

3. 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;

4. identified as having mild cognitive impairment by the HK-MoCA 5-Min Protocol (= 7th age- and education-corrected percentile cut-off score);

5. not engaged in regular exercise (defined as < 150 min of moderate-intensity exercise per week).

Exclusion Criteria:

1. inadequate reading and verbal Cantonese comprehension for the study activities;

2. diagnosed with dementia;

3. unable to use mobile phone text messaging applications (e.g., WhatsApp).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Lung Cancer
• Lung Neoplasms
• Neoplasms
• Physical Inactivity

Intervention

Behavioral:
• Regular message 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-type support message delivery
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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hong Kong Montreal Cognitive Assessment (HK-MoCA)	Primary outcome: objective cognitve function	at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Primary	Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)	Primary outcome: subjective cognitve function	at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Secondary	International Physical Activity Questionnaire-Short Form (IPAQ-SF)	Physical activity	at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Secondary	Self-efficacy for exercise (SEE)	Self-efficacy for exercise	at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Secondary	Patient Health Questionnaire 4 item (PHQ-4)	Psychological well-being	at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Secondary	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	Quality of life	at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)