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Lung CancerNCT06377124

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

A study testing 3S intervention and GH information in people with Lung Cancer, run by The University of Hong Kong at 3 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Lung Cancer
What is being tested?
3S intervention and GH information
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
3 sitesHong Kong
Study dates
22 Apr 2024to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • Preparing for lung operation
  • Skeletal fragility
  • Serious active infection
  • Inability to walk
  • Previously untreated symptomatic brain metastases
  • Severe respiratory insufficiency
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Agnes Yuen Kwan Lai, PhD contact

852 3970 2917

ayklai@hkmu.edu.hk

Hong Kong3 sites, 3 recruiting

  • Queen Elizabeth Hospital

    Hong Kong, Ho ManTin

    Maggie Lit, MN, (852) 39702917, blpkm01@ha.org.hk

    ayklai@hkmu.edu.hk

    Recruiting

  • Queen Mary Hospital

    Hong Kong

    Agnes YK Lai, PhD, 3970-2903, ayklai@hkmu.edu.hk

    Agnes Yuen Kwan Lai, PhD

    Not yet recruiting

  • United Christian Hospital

    Hong Kong

    Shu wah Ng, MSc, 39702917, ngsw1@ha.org.hk

    Recruiting

Other trials in Hong Kong

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
3S intervention, GH information
Keywords
Lung Cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3S interventionBehavioural

    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 informationBehavioural

    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.
Study groups in NCT06377124
Study groupRoleWhat they receive
The 3S intervention groupExperimentalReceive information and support on self-management of lung cancer
Receives: Behavioral: 3S intervention
The GH information groupPlacebo comparatorReceive general health information such as sleep hygiene, environmental hygiene, etc.
Receives: Behavioral: GH information

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 8-week follow-up

Secondary outcomes (25)

  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.

    Measured: Baseline and 24-week follow-up

  2. Change in patient activation

    Measured by a 13-item Patient Activation Measure with a 5-point Likert response scale from 0 to 4. Raw scores are transformed to a scale of 0-100 with higher scores indicating a higher activation in self-management.

    Measured: Baseline, 8-week and 24-week follow-up

  3. Change in general self-efficacy

    Measured by a 10-item General Self-efficacy Scale with a 4-point Likert response scale from 1 to 4, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

    Measured: Baseline, 8-week and 24-week follow-up

  4. Change in acceptance of illness

    This is measured by a 12-item Peaceful Acceptance subscale of the Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire. Each item ranges between 1 and 4. A higher score indicates a greater extent of acceptance of the cancer diagnosis.

    Measured: Baseline, 8-week and 24-week follow-up

  5. Change in physical activity level

    Measured the days and duration of physical activity level (light, moderate and vigorous) and sitting time in the past 7 days by the International Physical Activity Questionnaire (short version) with 4 questions.

    Measured: Baseline, 8-week and 24-week follow-up

  6. Change in diet habit

    Measured by 10-item dietary intake and practice outcome based questions

    Measured: Baseline, 8-week and 24-week follow-up

  7. Change in smoking and drinking habits

    Measured by self-reported drinking and smoking frequency

    Measured: Baseline, 8-week and 24-week follow-up

  8. Change in health status

    Measured by 5-item EuroQol-5D Questionnaire. Each item is a different dimension that ranges from level 1-5, a higher level indicates a more severe level of perceived problem of that dimension.

    Measured: Baseline, 8-week and 24-week follow-up

  9. Change in anxiety symptoms of patients

    Measured by a 7-item Generalised Anxiety Disorder Assessment. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 21. The higher scores the greater severity of anxiety symptoms.

    Measured: Baseline, 8-week and 24-week follow-up

  10. Change in depression symptoms of patients

    Measured by a 9-item Patient Health Questionnaire. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 27. The higher scores the greater severity of depression symptoms.

    Measured: Baseline, 8-week and 24-week follow-up

  11. Change in social and family support

    Measured by 8-item Family and Friend Subscales of Multidimensional Scale of Perceived Social Support with a 7-point Likert scale. Each scale ranges from 4 to 28. A higher score equates with higher social support.

    Measured: Baseline, 8-week and 24-week follow-up

  12. Change in adherence to agreed preset health-related goals

    Measured by web-based platform (WhatsApp) in which patients will be asked to self-report whether they have completed their previously agreed health-related or general hygiene goals with nurses on a weekly basis. Adherence will be assessed by the frequency of self-reported goal completion by patients.

    Measured: Baseline, 8-week and 24-week follow-up

  13. Change in symptom severity

    Measured by 13-item European Organization for Research and Treatment of Cancer on symptom severity with a 4-point Likert scale. A higher score indicates a higher level of symptom severity.

    Measured: Baseline, 8-week and 24-week follow-up

  14. Change in functional exercise capacity

    Measured by a 6-minute walk test. The distance of participant walked with the instructions to walk back and forth at their own pace to a designated spot for 6 minutes.

    Measured: Baseline, 8-week and 24-week follow-up

  15. Change in lower limb strength

    Measured by a 30-second chair stand test. The number of participant stood up repeatedly from a chair for 30 seconds.

    Measured: Baseline, 8-week and 24-week follow-up

  16. Change in hand grip strength

    Measured by a dynamometer

    Measured: Baseline, 8-week and 24-week follow-up

  17. Change in flexibility

    Measured by a Chair sit and reach test.

    Measured: Baseline, 8-week and 24-week follow-up

  18. Change in balance

    Measured by a single-leg stance test

    Measured: Baseline, 8-week and 24-week follow-up

  19. Change in body composition

    Calculated by ratio of body weight and body height

    Measured: Baseline, 8-week and 24-week follow-up

  20. Change in objective physical activity level

    Measured by a 7-day waist-worn accelerometer

    Measured: Baseline, 8-week and 24-week follow-up

  21. Change in objective sleep quality

    Measured by a sleep-wake monitor (Motionlogger MicroWatch)

    Measured: Baseline, 8-week and 24-week follow-up

  22. Change in burden of family caregivers (For FCGs)

    Measured by the 24-item Caregiver Burden Inventory with a 5-point Likert scale from 0 to 4. Total score ranges from 0 to 96 with higher score indicating a higher caregiver burden.

    Measured: Baseline, 8-week and 24-week follow-up

  23. Change in quality of life of family caregivers (For FCGs)

    Measured by the 35-item Caregiver Quality of Life Index-Cancer scale with a 5-point Likert scale from 0 to 4. Total score ranges from 0 to 140. Higher score indicates a higher quality of life.

    Measured: Baseline, 8-week and 24-week follow-up

  24. Change in anxiety symptoms of family caregivers (For FCGs)

    Measured by a 7-item Generalised Anxiety Disorder Assessment. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 21. The higher scores the greater severity of anxiety symptoms.

    Measured: Baseline, 8-week and 24-week follow-up

  25. Change in depression symptoms of family caregivers (For FCGs)

    Measured by a 9-item Patient Health Questionnaire. Each item asks the individual to rate the severity of his or her symptoms with a 4-point Likert scale. The total score ranges from 0 to 27. The higher scores the greater severity of depression symptoms.

    Measured: Baseline, 8-week and 24-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start22 Apr 2024
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06377124
Sponsor's protocol ID
UW21-507
Status last verified
Mar 2025
First submitted
9 Apr 2024
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For those who want the patient data, please contact PI directly by written email.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31228180

Questions about this trial

What is this clinical trial studying?

A study testing 3S intervention and GH information in people with Lung Cancer, run by The University of Hong Kong at 3 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Agnes Yuen Kwan Lai, PhD (852 3970 2917, ayklai@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in health-related quality of life (time frame: Baseline and 8-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06377124, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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Clinical Trial NCT06377124 | AzTrials