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Trial Title:
A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients
NCT ID:
NCT06377124
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Outcomes Assessor)
Masking description:
The outcome assessor was not aware of which groups the patients belonged to.
Intervention:
Intervention type:
Behavioral
Intervention name:
3S intervention
Description:
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.
Arm group label:
The 3S intervention group
Intervention type:
Behavioral
Intervention name:
GH information
Description:
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.
Arm group label:
The GH information group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Mary Hospital
Address:
City:
Hong Kong
Country:
Hong Kong
Contact:
Last name:
Agnes YK Lai, PhD
Phone:
3970-2903
Email:
ayklai@hkmu.edu.hk
Investigator:
Last name:
Agnes Yuen Kwan Lai, PhD
Email:
Principal Investigator
Start date:
April 22, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Queen Mary Hospital, Hong Kong
Agency class:
Other
Collaborator:
Agency:
The Queen Elizabeth Hospital
Agency class:
Other
Collaborator:
Agency:
United Christian Hospital
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06377124
