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Recruiting NCT06377124

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

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3S intervention, GH information.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Change in health-related quality of life [Time frame: Baseline and 8-week follow-up]
Secondary outcome measures (12)
  • Change in health-related quality of life [Time frame: Baseline and 24-week follow-up]
  • Change in patient activation [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in general self-efficacy [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in acceptance of illness [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in physical activity level [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in diet habit [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in smoking and drinking habits [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in health status [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in anxiety symptoms of patients [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in depression symptoms of patients [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in social and family support [Time frame: Baseline, 8-week and 24-week follow-up]
  • Change in adherence to agreed preset health-related goals [Time frame: Baseline, 8-week and 24-week follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Hong Kong · 3 centers
  • Queen Elizabeth Hospital — Hong Kong
  • Queen Mary Hospital — Hong Kong
  • United Christian Hospital — Hong Kong

Publications

  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06377124 · UW21-507

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗