A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients

Официальное название

A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Patients With Lung Cancer - A Pragmatic Randomized Controlled Trial With Mixed-method Evaluation

Обзор

Lung cancers patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The current study attempts to explore the efficacy of the Smart Self-Management Support Programme (3S) in improving quality of life of patients using self-management support programme with mobile devices.

Подробное описание

Lung cancer (LC) is the most and second most common cancer globally and locally respectively. LC patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The symptom burden is greater than other cancers and adversely affects quality of life. Care of LC patients has shifted from a purely disease-centered approach on survival-related outcomes to person-centered approach with emphasis on quality-of-life outcomes.

Self-management support programme (SMS) is perceived to supplement regular medical treatments and follow-up and cost-effective in cancer care. Besides, digital technologies have been used in patient empowerment digital platform to improve self-management of cancer patients. Using the self-management support programme and mobile devices, the Smart Self-Management Support Programme (3S) attempts to improve quality of life of patients.

The current study aims to examine the efficacy of 3S on improving quality of life and patient activation (knowledge, skills, and confidence for self-management) in the 3S intervention group, compared to the general health (GH) control group. It also aims to examine the changes in the burden of care, anxiety and depression symptoms, and quality of life of the family caregivers (FCGs) of the patients in the 3S group, compared to FCGs of the patients in the GH group.

We also conduct process valuations to assess the essential features of context, implementation, and impact mechanism, and cost-effectiveness evaluation to examine health care resource utilisation and cost-effectiveness analysis.

160 patients with lung cancer will be recruited, and 160 family caregivers will also be invited to join the study.

Вмешательства

• Поведенческое 3S intervention
  The 3S intervention includes information and support related to self-management of lung cancer, including 1. an individual 3S session at baseline, 2. 24-week messaging, telephone coaching and hotline services.
• Поведенческое GH information
  The GH information includes information related to general health, including 1. an individual GH session at baseline, 2. 24-week messaging, telephone coaching and hotline services.

Первичные конечные точки

• Change in health-related quality of life [Срок оценки: Baseline and 8-week follow-up]

Вторичные конечные точки (12)

• Change in health-related quality of life [Срок оценки: Baseline and 24-week follow-up]
• Change in patient activation [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in general self-efficacy [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in acceptance of illness [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in physical activity level [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in diet habit [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in smoking and drinking habits [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in health status [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in anxiety symptoms of patients [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in depression symptoms of patients [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in social and family support [Срок оценки: Baseline, 8-week and 24-week follow-up]
• Change in adherence to agreed preset health-related goals [Срок оценки: Baseline, 8-week and 24-week follow-up]

Критерии участия

Patients:

Критерии включения

• Aged 18 years or above
• Diagnosis of advanced-stage (stage III or stage IV) non-small cell lung cancer
• Ambulatory and capable of all self-care activities (ECOG ≤2)
• Either undergoing or has finished oncology therapy
• Mentally, cognitively and physically fit to join as determined by the doctor in charge and responsible clinical investigators
• Can speak and read Chinese
• Willing to complete the patient-reported outcome questionnaire
• Has a smartphone with WhatsApp or WeChat

Критерии исключения

• Preparing for lung operation
• Skeletal fragility
• Serious active infection
• Inability to walk
• Previously untreated symptomatic brain metastases
• Severe respiratory insufficiency
• Uncontrolled pain
• Diagnosed psychiatric illness with or without medication

Family Caregivers:

Критерии включения

• Aged 18 years or above
• Family caregivers of recruited patients

Критерии исключения

• Unable to speak and read Chinese
• Unwilling to complete the patient-reported outcome questionnaire

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Гонконг · 3 центра

• Queen Elizabeth Hospital — Гонконг
• Queen Mary Hospital — Гонконг
• United Christian Hospital — Гонконг

Публикации

• Kondylakis H, Bucur A, Crico C, Dong F, Graf N, Hoffman S, Koumakis L, Manenti A, Marias K, Mazzocco K, Pravettoni G, Renzi C, Schera F, Triberti S, Tsiknakis M, Kiefer S. Patient empowerment for cancer patients through a novel ICT infrastructure. J Biomed Inform. 2020 Jan;101:103342. doi: 10.1016/j.jbi.2019.103342. Epub 2019 Dec 6. PMID 31816400
• Saetan P, Chaiviboontham S, Pokpalagon P, Chansriwong P. The Effects of the Respiratory Rehabilitation Program on Perceived Self-Efficacy and Dyspnea in Patients with Lung Cancer. Asian Nurs Res (Korean Soc Nurs Sci). 2020 Dec;14(5):277-285. doi: 10.1016/j.anr.2020.08.010. Epub 2020 Sep 8. PMID 32916339
• Zhu X, Han S, Chu H, Wang M, Chen S. Influence of self-management exercise intervention on the cancer related fatigue severity and self-management efficacy of patients with non-small cell lung cancer after operation. J Pak Med Assoc. 2020 Sep;70 [Special Issue](9):88-93. PMID 33177734
• Hernandez Silva E, Lawler S, Langbecker D. The effectiveness of mHealth for self-management in improving pain, psychological distress, fatigue, and sleep in cancer survivors: a systematic review. J Cancer Surviv. 2019 Feb;13(1):97-107. doi: 10.1007/s11764-018-0730-8. Epub 2019 Jan 11. PMID 30635865
• Ji W, Kwon H, Lee S, Kim S, Hong JS, Park YR, Kim HR, Lee JC, Jung EJ, Kim D, Choi CM. Mobile Health Management Platform-Based Pulmonary Rehabilitation for Patients With Non-Small Cell Lung Cancer: Prospective Clinical Trial. JMIR Mhealth Uhealth. 2019 Jun 21;7(6):e12645. doi: 10.2196/12645. PMID 31228180

Идентификаторы

NCT: NCT06377124 · UW21-507

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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