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NCT Number: NCT06377124

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital, Hong Kong, Ho ManTin

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3S intervention

Behavioral

The 3S intervention includes information and support related to self-management of lung cancer, including

  • an individual 3S session at baseline,
  • 24-week messaging, telephone coaching and hotline services.

GH information

Behavioral

The GH information includes information related to general health, including

  • an individual GH session at baseline,
  • 24-week messaging, telephone coaching and hotline services.

Primary outcomes

  1. Change in health-related quality of life

    Time frame: Baseline and 8-week follow-up

    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.

Secondary outcomes

  1. Change in health-related quality of life

    Time frame: Baseline and 24-week follow-up

    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.

  2. Change in patient activation

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  3. Change in general self-efficacy

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  4. Change in acceptance of illness

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  5. Change in physical activity level

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  6. Change in diet habit

    Time frame: Baseline, 8-week and 24-week follow-up

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

  7. Change in smoking and drinking habits

    Time frame: Baseline, 8-week and 24-week follow-up

    Measured by self-reported drinking and smoking frequency

  8. Change in health status

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  9. Change in anxiety symptoms of patients

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  10. Change in depression symptoms of patients

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  11. Change in social and family support

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

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

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  13. Change in symptom severity

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  14. Change in functional exercise capacity

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

  15. Change in lower limb strength

    Time frame: Baseline, 8-week and 24-week follow-up

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

  16. Change in hand grip strength

    Time frame: Baseline, 8-week and 24-week follow-up

    Measured by a dynamometer

  17. Change in flexibility

    Time frame: Baseline, 8-week and 24-week follow-up

    Measured by a Chair sit and reach test.

  18. Change in balance

    Time frame: Baseline, 8-week and 24-week follow-up

    Measured by a single-leg stance test

  19. Change in body composition

    Time frame: Baseline, 8-week and 24-week follow-up

    Calculated by ratio of body weight and body height

  20. Change in objective physical activity level

    Time frame: Baseline, 8-week and 24-week follow-up

    Measured by a 7-day waist-worn accelerometer

  21. Change in objective sleep quality

    Time frame: Baseline, 8-week and 24-week follow-up

    Measured by a sleep-wake monitor (Motionlogger MicroWatch)

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

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

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

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

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

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

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

    Time frame: Baseline, 8-week and 24-week follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Agnes Yuen Kwan Lai, PhD

CONTACT

[email protected]

852 3970 2917

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Queen Mary Hospital, Hong Kong
  • The Queen Elizabeth Hospital
  • United Christian Hospital

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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