Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-01 @ 1:12 PM
Study NCT ID:
NCT06003335
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2023-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': 'Primary outcome: objective cognitve function'}, {'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)', 'description': 'Primary outcome: subjective cognitve function'}], 'secondaryOutcomes': [{'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)', 'description': 'Physical activity'}, {'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)', 'description': 'Self-efficacy for exercise'}, {'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)', 'description': 'Psychological well-being'}, {'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)', 'description': 'Quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms', 'Lung Cancer', 'Physical Inactivity', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '40711466', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: To examine the effectiveness of a personalised motivational messaging intervention for improving cognitive function in lung cancer survivors.\n\nHypothesis to be tested: Lung cancer survivors receiving personalised motivational messaging will have better cognitive function than usual care.\n\nDesign and subjects: A randomised controlled trial in 196 lung cancer survivors with cancer-related cognitive impairment.\n\nIntervention: 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.\n\nMain 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).\n\nData 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.\n\nExpected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged ≥ 18 years;\n2. diagnosed with stage I-III non-metastatic NSCLC cancer;\n3. 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;\n4. identified as having mild cognitive impairment by the HK-MoCA 5-Min Protocol (≤ 7th age- and education-corrected percentile cut-off score);\n5. not engaged in regular exercise (defined as \\< 150 min of moderate-intensity exercise per week).\n\nExclusion Criteria:\n\n1. inadequate reading and verbal Cantonese comprehension for the study activities;\n2. diagnosed with dementia;\n3. unable to use mobile phone text messaging applications (e.g., WhatsApp).'}, 'identificationModule': {'nctId': 'NCT06003335', 'briefTitle': 'Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Increasing Physical Activity Through Personalised Motivational Messaging to Improve Cognitive Function in Lung Cancer Survivors With Cancer-related Cognitive Impairment: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'uhongkongc9ttii37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IG', 'description': '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.', 'interventionNames': ['Behavioral: Regular message delivery', 'Behavioral: Chat-type support message delivery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CG 1', 'description': '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.', 'interventionNames': ['Behavioral: Regular message delivery']}, {'type': 'NO_INTERVENTION', 'label': 'CG 2', 'description': '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': [{'name': 'Regular message delivery', 'type': 'BEHAVIORAL', '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.", 'armGroupLabels': ['CG 1', 'IG']}, {'name': 'Chat-type support message delivery', 'type': 'BEHAVIORAL', '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.", 'armGroupLabels': ['IG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Mu-Hsing Ho, PhD', 'role': 'CONTACT', 'email': 'mhbho@hku.hk', 'phone': '+852 39102787'}], 'facility': 'School of Nursing, The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}