Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors With Cancer-related Cognitive Impairment: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- The University of Hong Kong
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •inadequate reading and verbal Cantonese comprehension for the study activities;
- •diagnosed with dementia;
- •unable to use mobile phone text messaging applications (e.g., WhatsApp).
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Time Frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Primary outcome: subjective cognitve function
Hong Kong Montreal Cognitive Assessment (HK-MoCA)
Time Frame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Primary outcome: objective cognitve function
Secondary Outcomes
- Self-efficacy for exercise (SEE)(at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up))
- Patient Health Questionnaire 4 item (PHQ-4)(at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up))
- International Physical Activity Questionnaire-Short Form (IPAQ-SF)(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 (EORTC QLQ-C30)(at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up))