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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- Change in health-related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor was not aware of which groups the patients belonged to.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •Inclusion criteria:
- •Aged 18 years or above
- •Family caregivers of recruited patients
- •Exclusion criteria:
- •Unable to speak and read Chinese
- •Unwilling to complete the patient-reported outcome questionnaire
结局指标
主要结局
Change in health-related quality of life
时间窗: Baseline and 8-week follow-up
Measured by a 30-item European Organization for Research and Treatment of Cancer and Lung Module. All scale scores are linearly converted to a range from 0 to 100. Higher scores indicate better functioning and quality of life.
次要结局
- Change in health-related quality of life(Baseline and 24-week follow-up)
- Change in patient activation(Baseline, 8-week and 24-week follow-up)
- Change in acceptance of illness(Baseline, 8-week and 24-week follow-up)
- Change in physical activity level(Baseline, 8-week and 24-week follow-up)
- Change in anxiety symptoms of patients(Baseline, 8-week and 24-week follow-up)
- Change in smoking and drinking habits(Baseline, 8-week and 24-week follow-up)
- Change in social and family support(Baseline, 8-week and 24-week follow-up)
- Change in diet habit(Baseline, 8-week and 24-week follow-up)
- Change in general self-efficacy(Baseline, 8-week and 24-week follow-up)
- Change in health status(Baseline, 8-week and 24-week follow-up)
- Change in symptom severity(Baseline, 8-week and 24-week follow-up)
- Change in body composition(Baseline, 8-week and 24-week follow-up)
- Change in objective physical activity level(Baseline, 8-week and 24-week follow-up)
- Change in burden of family caregivers (For FCGs)(Baseline, 8-week and 24-week follow-up)
- Change in depression symptoms of patients(Baseline, 8-week and 24-week follow-up)
- Change in adherence to agreed preset health-related goals(Baseline, 8-week and 24-week follow-up)
- Change in lower limb strength(Baseline, 8-week and 24-week follow-up)
- Change in hand grip strength(Baseline, 8-week and 24-week follow-up)
- Change in functional exercise capacity(Baseline, 8-week and 24-week follow-up)
- Change in balance(Baseline, 8-week and 24-week follow-up)
- Change in quality of life of family caregivers (For FCGs)(Baseline, 8-week and 24-week follow-up)
- Change in flexibility(Baseline, 8-week and 24-week follow-up)
- Change in anxiety symptoms of family caregivers (For FCGs)(Baseline, 8-week and 24-week follow-up)
- Change in objective sleep quality(Baseline, 8-week and 24-week follow-up)
- Change in depression symptoms of family caregivers (For FCGs)(Baseline, 8-week and 24-week follow-up)
研究者
Dr. Agnes Yuen-Kwan Lai
Honorary Assistant Professor
The University of Hong Kong