이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

폐암 생존자의 인지 기능 향상을 위한 개인화된 동기 부여 메시지를 통한 신체 활동 증가

2026년 6월 2일 업데이트: The University of Hong Kong

암 관련 인지 장애가 있는 폐암 생존자의 인지 기능을 개선하기 위한 개인화된 동기 부여 메시지를 통한 신체 활동 증가: 무작위 통제 시험

목표: 폐암 생존자의 인지 기능을 개선하기 위한 개인화된 동기 부여 메시지 중재의 효과를 조사합니다.

테스트할 가설: 개인화된 동기 부여 메시지를 받는 폐암 생존자는 일반적인 치료보다 더 나은 인지 기능을 가질 것입니다.

설계 및 주제: 암 관련 인지 장애가 있는 196명의 폐암 생존자를 대상으로 한 무작위 통제 시험.

개입: 개입 그룹은 3개월 동안 웨어러블 활동 추적기를 착용하고 인스턴트 메시징 애플리케이션(예: WhatsApp)을 통해 개인화된 동기 부여 메시지를 받아 신체 운동을 촉진합니다. 개입은 1) 참가자가 제안된 신체 활동 목표를 선택할 수 있도록 원하는 시간과 빈도로 정기적으로 메시지를 전송하고 2) 목표 설정, 실시간 상담 및 실질적인 조언과 같은 채팅형 메시지를 통한 지원을 포함합니다. 대조군은 후속 조사를 위한 알림 문자 메시지가 포함된 인지 장애에 대한 전단지를 받게 됩니다.

주요 결과 측정: 데이터는 기준선(T0), 3개월(T1; 개입 제공 직후) 및 6개월(T2; 장기 후속 조치)에 수행됩니다. 1차 결과는 HK-MoCA(객관적) 및 FACT-Cog(Functional Assessment of Cancer Therapy-Cognitive Function) 척도(주관적)로 측정한 인지 기능입니다. 2차 결과는 신체 활동(IPAQ-SF), 운동 자기효능감(SEE), 심리적 웰빙(PHQ-4) 및 삶의 질(EORTC QLQ-C30)입니다.

데이터 분석: Intention-to-treat, post-trial qualitative(중재 준수) 및 비용 효율성 분석이 수행됩니다. 우리는 CONSORT-EHEALTH 체크리스트를 따를 것입니다.

예상 결과: 이 시험은 폐암 생존자의 인지 기능 개선 및 신체 활동 증가에 대한 제안된 개입의 효과에 대한 증거를 제공할 것입니다.

연구 개요

상세 설명

  1. Background of the Research Project Lung cancer is a leading cause of cancer-related mortality worldwide. In Hong Kong, it accounts for over 26% of all cancer deaths, with 80% to 85% being non-small cell lung cancers (NSCLC). While cancer-related symptoms affecting overall survival and quality of life have been extensively studied, cancer-related cognitive impairment (CRCI) remains a critical yet under-researched complication. CRCI refers to cognitive dysfunction, including impaired working or short-term memory, inattention, disorientation, and declines in executive function, language comprehension, and processing speed. More than 50% of patients with non-central nervous system (CNS) cancers present with CRCI after primary treatments. Our preliminary pilot data indicated that the prevalence of cognitive impairment in attention and memory among lung cancer patients was 35.4% and 58.4%, respectively. CRCI significantly impacts patients' functional independence and can lead to anxiety, depression, and sleep disorders, highlighting an urgent need for effective, accessible interventions.
  2. Theoretical and Clinical Background Clinically, several studies and systematic reviews have demonstrated that exercise and physical activity interventions can alleviate CRCI in cancer patients. However, traditional exercise programs often suffer from poor long-term adherence and a lack of sustained motivation once the formal intervention period ends. To address this translational gap, this study utilizes an Ecological Momentary Intervention (EMI) approach via mobile health (mHealth) technology. EMI delivers health interventions through instant messaging (IM) applications (e.g., WhatsApp) in a personalized, real-time, and in-situ format.

    Theoretically, the intervention is rigorously grounded in Social Cognitive Theory (SCT), which posits that personal and environmental factors influence health behaviors. The intervention design operationalizes key SCT constructs:

    Behavioral Capability: Providing tailored information to increase physical activity based on self-care needs.

    Outcome Expectations: Educating participants on how physical activity improves neurocognitive function.

    Observational Learning: Utilizing case vignettes of other survivors. Self-efficacy: Fostering belief in behavioral change through collaborative goal-setting and chat-based support.

    Reinforcement: Providing systematic feedback and positive validation on behavioral changes.

  3. Objectives The primary objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of an SCT-based, personalized motivational messaging intervention delivered via an instant messaging application in improving cognitive function among lung cancer survivors with CRCI. The secondary objectives are to assess the intervention's impact on physical activity levels, exercise self-efficacy, psychological well-being, and health-related quality of life, as well as to evaluate the cost-effectiveness and participants' qualitative experiences of the intervention.
  4. Main Research Questions and Hypotheses Research Question: Does a personalized motivational messaging intervention, utilizing wearable activity trackers and real-time IM support, effectively mitigate cognitive decline and promote physical activity in lung cancer survivors compared to standard care?

    Hypotheses: We hypothesize that lung cancer survivors with CRCI receiving the personalized motivational messaging intervention will demonstrate (1) significantly greater improvements in objective and subjective cognitive function, and (2) significantly increased physical activity levels compared to those receiving standard care.

  5. Study Design and Methods This study is a randomized controlled trial (RCT) comprising 124 lung cancer survivors, augmented by a post-trial qualitative process evaluation.

    Randomization and Blinding: Participants will be randomly allocated to either the intervention or control arm. A computer-generated randomization sequence will be created by an independent statistician using block randomization with varying block sizes (blocks of 4, 6, and 8). Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Outcome assessors and the trial statistician will be blinded to group allocation.

    Intervention Arm: Participants will be equipped with a wearable activity tracker for 3 months. They will receive personalized motivational messages from a comprehensive message library developed by an oncology specialist and a research nurse trained in motivational interviewing. The intervention features two components: (a) regular message delivery whose frequency and timing are tailored to participant preferences, and (b) interactive chat-type support facilitating goal setting, real-time counseling, and practical advice.

    Control Arm: Participants will receive an informational leaflet containing basic CRCI education and standard text message reminders for follow-up assessments, without the personalized motivational or interactive chat components.

    Data Collection & Analysis: Quantitative assessments will occur at baseline (T0), 3 months (T1), and 6 months (T2). An Intention-to-Treat (ITT) analysis will be performed. Generalized Estimating Equations (GEE) will be utilized to estimate between-group and within-group differences across time points, adjusting for baseline covariates. GEE robustly handles missing longitudinal data without manual imputation.

    Economic & Qualitative Evaluation: A cost-effectiveness analysis will calculate the Incremental Cost-Effectiveness Ratio (ICER) using Quality-Adjusted Life Years (QALYs) derived from EORTC QLQ-C30 scores. Additionally, a post-trial qualitative study using purposive maximum variation sampling will conduct in-depth interviews (analyzed via 7-step thematic analysis in NVivo) to understand intervention compliance and participant experience.

  6. Expected Outcomes The trial is expected to yield robust quantitative evidence that personalized EMI significantly improves cognitive domains (such as attention, verbal learning, and executive function) and sustains moderate-to-vigorous physical activity in lung cancer survivors. Furthermore, the trial is expected to demonstrate high feasibility, user acceptability, and cost-effectiveness compared to standard oncological supportive care.
  7. Significance of the Study This study addresses a critical gap in cancer survivorship by targeting CRCI-a prevalent but frequently overlooked symptom. If proven effective, this intervention provides an efficient, highly scalable, real-world, and cost-effective digital health solution. Furthermore, the chat-log data and user preference profiles generated from this study will establish a foundational database for the future development of Artificial Intelligence (AI) chatbot services for physical activity management, aligning with global smart-city healthcare blueprints and advancing the implementation science of mHealth in oncology.

연구 유형

중재적

등록 (실제)

124

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Hong Kong
      • Hong Kong, Hong Kong, 홍콩
        • School of Nursing, The University of Hong Kong

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  1. 18세 이상
  2. 병기 I-III 비전이성 NSCLC 암으로 진단됨;
  3. 추가 암의 재발 또는 발생 없이 기준선 평가 6개월 내지 5년 전에 치료 목적으로 1차 치료(수술, 화학요법 및/또는 방사선 요법)를 완료함;
  4. HK-MoCA 5분 프로토콜에 의해 경미한 인지 장애가 있는 것으로 식별됨(≤ 7세 및 교육 보정 백분위수 컷오프 점수)
  5. 규칙적인 운동을 하지 않음(주당 중강도 운동 150분 미만으로 정의됨).

제외 기준:

  1. 연구 활동에 대한 부적절한 읽기 및 구두 광동어 이해;
  2. 치매 진단;
  3. 휴대폰 문자 메시지 애플리케이션(예: WhatsApp)을 사용할 수 없습니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Motivational Personalized Messaging + Regular Health Education
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.
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-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.
활성 비교기: Regular Health Education
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.
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.
간섭 없음: Self-management
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Hong Kong Montreal Cognitive Assessment
기간: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures objective cognitve function. It consists of 4 dimensions (attention, memory, language/executive function, and orientation). The total score ranges from a minimum of 0 to a maximum of 30. Higher scores indicate better cognitive function, while lower scores suggest cognitive decline or impairment. The categorization of subject scores are corrected by years of education and age.
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Functional Assessment of Cancer Therapy-Cognitive Function
기간: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

It measures subjective cognitve function and its impact on quality of life in cancer patients.

It has 4 dimensions. 1. Perceived Cognitive Impairments (PCI): Range 0-72. 2. Perceived Cognitive Abilities (PCA): Range 0-36. 3. Comments from Others (Oth): Range 0-16. 4. Impact on Quality of Life (QoL): Range 0-16. Because negatively worded items are reverse-scored, higher scores across all sub-dimensions mean better outcomes: fewer perceived impairments, better perceived abilities, fewer negative comments from others, and less negative impact on quality of life.

at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

2차 결과 측정

결과 측정
측정값 설명
기간
International Physical Activity Questionnaire-Short Form
기간: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures the level of physical activity undertaken by adults. It covers 4 dimensions: vigorous-intensity activities, moderate-intensity activities, walking, and sitting. The score is calculated as continuous MET-minutes/week. The minimum value is 0 MET-minutes/week, and the maximum value is theoretically unlimited. Higher scores indicate a higher volume and intensity of physical activity, meaning the individual is more physically active.
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Exercise Self-efficacy Scale
기간: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures an individual's self-confidence in their ability to continue exercising despite facing various barriers (e.g., fatigue, bad weather, lack of time). It is unidimensional (1 dimension). The total score typically ranges from a minimum of 0 to a maximum of 70 (depending on the exact version used). Higher scores indicate greater self-efficacy, meaning the person has stronger confidence and belief in their ability to maintain a regular exercise routine.
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
Patient Health Questionnaire 4 item
기간: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures the core symptoms of anxiety and depression. It consists of 2 dimensions: anxiety (2 items) and depression (2 items). The total score ranges from a minimum of 0 to a maximum of 12. Each individual dimension ranges from 0 to 6. Higher scores indicate a higher burden of psychological distress, meaning the patient is experiencing more frequent or severe symptoms of anxiety and depression.
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
기간: at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)
It measures the health-related quality of life of cancer patients. It has 15 dimensions. All scores are linearly transformed to a range of 0 to 100. 1. Global Health Status/QoL (1 dimension): Range 0-100. Higher scores mean better overall health and quality of life. 2. Functional scales (5 dimensions: physical, role, emotional, cognitive, social): Range 0-100. Higher scores mean a higher/healthier level of functioning. 3. Symptom scales/items (9 dimensions: fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties): Range 0-100. Higher scores mean worse outcomes, indicating more severe symptoms or problems.
at baseline (T0), 3 months (T1; immediately after intervention delivery), and 6 months (T2; long-term follow up)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 2월 1일

기본 완료 (실제)

2026년 1월 31일

연구 완료 (실제)

2026년 1월 31일

연구 등록 날짜

최초 제출

2023년 8월 15일

QC 기준을 충족하는 최초 제출

2023년 8월 15일

처음 게시됨 (실제)

2023년 8월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 3월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

폐암에 대한 임상 시험

Regular message of health education에 대한 임상 시험

구독하다