Clinical trial NCT06003335: Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neoplasms
Lung Cancer
Physical Inactivity
Cognitive Impairment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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).

Primary outcomes:
measure: Hong Kong Montreal Cognitive Assessment (HK-MoCA)
timeFrame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
measure: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
timeFrame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Secondary outcomes:
measure: International Physical Activity Questionnaire-Short Form (IPAQ-SF)
timeFrame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
measure: Self-efficacy for exercise (SEE)
timeFrame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
measure: Patient Health Questionnaire 4 item (PHQ-4)
timeFrame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
References: