A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients
NCT ID: NCT06377124
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
320 participants
INTERVENTIONAL
2024-04-22
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT
NCT05331391
A Brief SMART Exercise Instant Messaging Support Intervention - a Pilot Study
NCT05050370
Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study
NCT04105647
Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
NCT05292521
the Quality of Life Assessment of Lung Cancer Patients in China
NCT01914120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
The general health information includes an individual session, messaging and phone contact related to general health information, and hotline services.
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The 3S intervention group
Receive information and support on self-management of lung cancer
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.
The GH information group
Receive general health information such as sleep hygiene, environmental hygiene, etc.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Aged 18 years or above
* Family caregivers of recruited patients
Exclusion Criteria
* 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:
* Unable to speak and read Chinese
* Unwilling to complete the patient-reported outcome questionnaire
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Queen Mary Hospital, Hong Kong
OTHER
The Queen Elizabeth Hospital
OTHER
United Christian Hospital
OTHER
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Agnes Yuen-Kwan Lai
Honorary Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Agnes Yuen Kwan Lai, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Nursing and Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Elizabeth Hospital
Hong Kong, Ho ManTin, Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
United Christian Hospital
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UW21-507
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.