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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06377124
• Other study ID #: UW21-507
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: The University of Hong Kong
• Contact: Agnes Yuen Kwan Lai, PhD
• Phone: 852 3970 2917
• Email: ayklai[@]hkmu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 devices.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: June 30, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• 3S intervention
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
The GH information includes information related to general health, including an individual GH session at baseline, 24-week messaging, telephone coaching and hotline services.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong, The Queen Elizabeth Hospital, United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	Change in diet habit	Measured by 10-item dietary intake and practice outcome based questions	Baseline, 8-week and 24-week follow-up
Secondary	Change in smoking and drinking habits	Measured by self-reported drinking and smoking frequency	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	Change in hand grip strength	Measured by a dynamometer	Baseline, 8-week and 24-week follow-up
Secondary	Change in flexibility	Measured by a Chair sit and reach test.	Baseline, 8-week and 24-week follow-up
Secondary	Change in balance	Measured by a single-leg stance test	Baseline, 8-week and 24-week follow-up
Secondary	Change in body composition	Calculated by ratio of body weight and body height	Baseline, 8-week and 24-week follow-up
Secondary	Change in objective physical activity level	Measured by a 7-day waist-worn accelerometer	Baseline, 8-week and 24-week follow-up
Secondary	Change in objective sleep quality	Measured by a sleep-wake monitor (Motionlogger MicroWatch)	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up
Secondary	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.	Baseline, 8-week and 24-week follow-up