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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
320
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.
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.
Queen Elizabeth Hospital
Hong Kong, Ho ManTin, Hong Kong
RECRUITINGQueen Mary Hospital
Hong Kong, Hong Kong
NOT_YET_RECRUITINGUnited Christian Hospital
Hong Kong, Hong Kong
RECRUITINGChange in health-related quality of life
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.
Time frame: Baseline and 8-week follow-up
Change in health-related quality of life
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.
Time frame: Baseline and 24-week follow-up
Change in patient activation
Measured by a 13-item Patient Activation Measure with a 5-point Likert response scale from 0 to 4. Raw scores are transformed to a scale of 0-100 with higher scores indicating a higher activation in self-management.
Time frame: Baseline, 8-week and 24-week follow-up
Change in general self-efficacy
Measured by a 10-item General Self-efficacy Scale with a 4-point Likert response scale from 1 to 4, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Time frame: Baseline, 8-week and 24-week follow-up
Change in acceptance of illness
This is measured by a 12-item Peaceful Acceptance subscale of the Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire. Each item ranges between 1 and 4. A higher score indicates a greater extent of acceptance of the cancer diagnosis.
Time frame: Baseline, 8-week and 24-week follow-up
Change in physical activity level
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Measured the days and duration of physical activity level (light, moderate and vigorous) and sitting time in the past 7 days by the International Physical Activity Questionnaire (short version) with 4 questions.
Time frame: Baseline, 8-week and 24-week follow-up
Change in diet habit
Measured by 10-item dietary intake and practice outcome based questions
Time frame: Baseline, 8-week and 24-week follow-up
Change in smoking and drinking habits
Measured by self-reported drinking and smoking frequency
Time frame: Baseline, 8-week and 24-week follow-up
Change in health status
Measured by 5-item EuroQol-5D Questionnaire. Each item is a different dimension that ranges from level 1-5, a higher level indicates a more severe level of perceived problem of that dimension.
Time frame: Baseline, 8-week and 24-week follow-up
Change in anxiety symptoms of patients
Measured by a 7-item Generalised Anxiety Disorder Assessment. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 21. The higher scores the greater severity of anxiety symptoms.
Time frame: Baseline, 8-week and 24-week follow-up
Change in depression symptoms of patients
Measured by a 9-item Patient Health Questionnaire. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 27. The higher scores the greater severity of depression symptoms.
Time frame: Baseline, 8-week and 24-week follow-up
Change in social and family support
Measured by 8-item Family and Friend Subscales of Multidimensional Scale of Perceived Social Support with a 7-point Likert scale. Each scale ranges from 4 to 28. A higher score equates with higher social support.
Time frame: Baseline, 8-week and 24-week follow-up
Change in adherence to agreed preset health-related goals
Measured by web-based platform (WhatsApp) in which patients will be asked to self-report whether they have completed their previously agreed health-related or general hygiene goals with nurses on a weekly basis. Adherence will be assessed by the frequency of self-reported goal completion by patients.
Time frame: Baseline, 8-week and 24-week follow-up
Change in symptom severity
Measured by 13-item European Organization for Research and Treatment of Cancer on symptom severity with a 4-point Likert scale. A higher score indicates a higher level of symptom severity.
Time frame: Baseline, 8-week and 24-week follow-up
Change in functional exercise capacity
Measured by a 6-minute walk test. The distance of participant walked with the instructions to walk back and forth at their own pace to a designated spot for 6 minutes.
Time frame: Baseline, 8-week and 24-week follow-up
Change in lower limb strength
Measured by a 30-second chair stand test. The number of participant stood up repeatedly from a chair for 30 seconds.
Time frame: Baseline, 8-week and 24-week follow-up
Change in hand grip strength
Measured by a dynamometer
Time frame: Baseline, 8-week and 24-week follow-up
Change in flexibility
Measured by a Chair sit and reach test.
Time frame: Baseline, 8-week and 24-week follow-up
Change in balance
Measured by a single-leg stance test
Time frame: Baseline, 8-week and 24-week follow-up
Change in body composition
Calculated by ratio of body weight and body height
Time frame: Baseline, 8-week and 24-week follow-up
Change in objective physical activity level
Measured by a 7-day waist-worn accelerometer
Time frame: Baseline, 8-week and 24-week follow-up
Change in objective sleep quality
Measured by a sleep-wake monitor (Motionlogger MicroWatch)
Time frame: Baseline, 8-week and 24-week follow-up
Change in burden of family caregivers (For FCGs)
Measured by the 24-item Caregiver Burden Inventory with a 5-point Likert scale from 0 to 4. Total score ranges from 0 to 96 with higher score indicating a higher caregiver burden.
Time frame: Baseline, 8-week and 24-week follow-up
Change in quality of life of family caregivers (For FCGs)
Measured by the 35-item Caregiver Quality of Life Index-Cancer scale with a 5-point Likert scale from 0 to 4. Total score ranges from 0 to 140. Higher score indicates a higher quality of life.
Time frame: Baseline, 8-week and 24-week follow-up
Change in anxiety symptoms of family caregivers (For FCGs)
Measured by a 7-item Generalised Anxiety Disorder Assessment. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 21. The higher scores the greater severity of anxiety symptoms.
Time frame: Baseline, 8-week and 24-week follow-up
Change in depression symptoms of family caregivers (For FCGs)
Measured by a 9-item Patient Health Questionnaire. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 27. The higher scores the greater severity of depression symptoms.
Time frame: Baseline, 8-week and 24-week follow-up