A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients

NCT06377124 | Recruiting DMC

• 1 other identifier: UW21-507
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 8-week follow-up

Secondary Outcomes (25)

• 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 general self-efficacy

  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

Study Arms (2)

The 3S intervention group

EXPERIMENTAL

Receive information and support on self-management of lung cancer

Behavioral: 3S intervention

The GH information group

PLACEBO COMPARATOR

Receive general health information such as sleep hygiene, environmental hygiene, etc.

Behavioral: GH information

Interventions

3S intervention BEHAVIORAL

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 3S intervention group

GH information BEHAVIORAL

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.

The GH information group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Aged 18 years or above
• Family caregivers of recruited patients
• Unable to speak and read Chinese
• Unwilling to complete the patient-reported outcome questionnaire

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• The Queen Elizabeth Hospital: collaborator
• United Christian Hospital: collaborator

Study Sites (3)

Queen Elizabeth Hospital

Hong Kong, Ho ManTin, Hong Kong

RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong

NOT YET RECRUITING

United Christian Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

• 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.

  PMID: 31816400 BACKGROUND

• 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.

  PMID: 32916339 BACKGROUND

• 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.

  PMID: 33177734 BACKGROUND

• 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.

  PMID: 30635865 BACKGROUND

• 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.

  PMID: 31228180 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Agnes Yuen Kwan Lai, PhD

  School of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Yuen Kwan Lai, PhD

CONTACT

852 3970 2917; ayklai@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was not aware of which groups the patients belonged to.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 22, 2024
• Study Start: April 22, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)