Clinical trial NCT06377124: A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: The Queen Elizabeth Hospital
name: United Christian Hospital
First posted: 2024-04-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 3S intervention includes an individual session, messaging and phone contact related to lung cancer self-management, and hotline services.

The general health information includes an individual session, messaging and phone contact related to general health information, and hotline services.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Patients:

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in health-related quality of life
timeFrame: Baseline and 8-week follow-up
Secondary outcomes:
measure: Change in health-related quality of life
timeFrame: Baseline and 24-week follow-up
measure: Change in patient activation
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in general self-efficacy
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in acceptance of illness
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in physical activity level
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in diet habit
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in smoking and drinking habits
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in health status
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in anxiety symptoms of patients
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in depression symptoms of patients
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in social and family support
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in adherence to agreed preset health-related goals
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in symptom severity
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in functional exercise capacity
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in lower limb strength
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in hand grip strength
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in flexibility
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in balance
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in body composition
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in objective physical activity level
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in objective sleep quality
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in burden of family caregivers (For FCGs)
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in quality of life of family caregivers (For FCGs)
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in anxiety symptoms of family caregivers (For FCGs)
timeFrame: Baseline, 8-week and 24-week follow-up
measure: Change in depression symptoms of family caregivers (For FCGs)
timeFrame: Baseline, 8-week and 24-week follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
state: Ho ManTin
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: United Christian Hospital
Study officials:
affiliation: School of Nursing and Health Sciences
name: Agnes Yuen Kwan Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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