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

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

NCT ID: NCT06003335

Condition: Neoplasms
Lung Cancer
Physical Inactivity
Cognitive Impairment

Conditions: Official terms:
Lung Neoplasms
Cognitive Dysfunction

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: Double (Investigator, Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Regular message delivery
Description: 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.
Arm group label: CG 1
Arm group label: IG

Intervention type: Behavioral
Intervention name: Chat-type support message delivery
Description: 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.
Arm group label: IG

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.

Criteria for eligibility:
Criteria:
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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: School of Nursing, The University of Hong Kong

Address:
City: Hong Kong
Country: Hong Kong

Contact:
Last name: Mu-Hsing Ho, PhD

Phone: +852 39102787
Email: mhbho@hku.hk

Start date: March 1, 2024

Completion date: April 30, 2025

Lead sponsor:
Agency: The University of Hong Kong
Agency class: Other

Source: The University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06003335