Lung CancerNCT05331391
A Mobile SMART Exercise Support Program to Improve Fatigue in Lung Cancer Patients - A RCT
A study testing Brief mobile SMART Exercise Support Program in people with Lung Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Lung cancer (LC) is a common cancer in the world. Among all symptoms, Fatigue is considered as the most distressing medical condition of LC. Prior studies revealed that physical activity effectively relieve fatigue and related problems. 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?
- Brief mobile SMART Exercise Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 and above;
- Diagnosis of Stage III or IV non-small cell lung cancer;
- Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10
- Self-reported engagement of <150 minutes of moderate intensity PA each week,
- Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)
- Either undergoing or finished oncology therapy, biological agents and/or support care;
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- Mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
- Able to speak and read Chinese;
- Willing to complete the patient-reported outcome questionnaire;
- Completion of the Physical Activity Readiness Questionnaire; and
- Possession of a smartphone with instant messaging functions such as WhatsApp or WeChat.
Who cannot join
- Those preparing for lung operation;
- Skeletal fragility;
- Serious active infection;
- Inability to walk;
- Previously untreated symptomatic brain metastases;
- Severe respiratory insufficiency;
- Uncontrolled pain; or
- Diagnosed psychiatric illness with or without medication such as major depressive disorder.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Agnes Lai, PhD, 852-3917-6283, agneslai@hku.hk
David Lam, PhD, 852-2255-4455, slnga@hku.hk
About this study
Official title: A Brief Mobile SMART Exercise Support Program to Improve Fatigue in Patients With Advanced Lung Cancer - A Pragmatic Randomized Controlled Trial With Outcome and Process Evaluation
Lung cancer (LC) is a common cancer in the world. Among all symptoms, Fatigue is considered as the most distressing medical condition of LC. Prior studies revealed that physical activity effectively relieve fatigue and related problems. The current study attempt to explore the effectiveness of SMART Exercise Support Program (SES) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (ALC) patients.
Read the detailed description
Lung cancer (LC) is the most and second most common cancer globally and locally, respectively. Nearly half of LC patients are diagnosed in the advanced stage. Fatigue is perceived to be the most distressing symptom. Physical activity has been proposed as an alternative treatment to relieve fatigue and related problems.
Mobile instant messaging applications (e.g. WhatsApp/WeChat) are popular and inexpensive for interactive messaging. A systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (PA), smoking cessation, and medication adherence.
The proposed randomized controlled trial (RCT) aims to examine the effectiveness of SES on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in ALC patients (SES group), compared to the General Hygiene Information (GHI, control) group.
Questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. Qualitative feedback will be obtained at the completion of the trial.
- Conditions
- Lung Cancer
- Being tested
- Brief mobile SMART Exercise Support Program
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mobile SMART Exercise Support ProgramBehavioural
Patients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule. Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation. Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Brief mobile SMART Exercise Support Program | Experimental | Patients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance. Receives: Behavioral: Brief mobile SMART Exercise Support Program |
| General Hygiene Information (GHI) | Placebo comparator | Patients will receive an individual session, instant messages and telephone coaching regarding general hygiene information. Receives: Behavioral: Brief mobile SMART Exercise Support Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue level
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale. The level of fatigue is measured on a five-point Likert scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
Measured: Baseline and 6 weeks
Secondary outcomes (18)
Change in fatigue level
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale. The level of fatigue is measured on a five-point Likert scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
Measured: Baseline and 6 months
Change in anxiety symptoms
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, 6 weeks, 6 months
Change in depression symptoms
Measured by a 9-item Patient Health Questionaire. 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, 6 weeks, 6 months
Change in physical activity level
Measured the days and duration of physical activity level and sitting time in the past 7 days by the International Physical Activity Questionnaire (short version) with 4 questions.
Measured: Baseline, 6 weeks, 6 months
Change in sleep quality
Measured by 7-item Severe Insomnia Index. 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 28. The higher scores the greater severity of insomnia.
Measured: Baseline, 6 weeks, 6 months
Change in health-related quality of life
Measured by a 30-item European Organization for Research and Treatment of Cancer and Lung Module. It contains five functioning scales (physical, social, role, cognitive, and emotional functioning), and eight symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbances, appetite loss, constipation, and diarrhoea), and financial impact, and overall quality of life. All scale scores are linearly converted to a range from 0 to 100. Higher scores indicate better functioning for the functioning scales and global QOL; for the symptom scales, higher scores indicate higher symptom burden.
Measured: Baseline, 6 weeks, 6 months
Change in happiness level
Measured by 4-item Subjective Happiness Scale with a 7-point Likert scale. Total scores range from 4 to 28. The highest scores reflect greater happiness.
Measured: Baseline, 6 weeks, 6 months
Change in cancer-related symptoms
Measured by 3 items of the Edmonton Symptom Assessment System Scale. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity.
Measured: Baseline, 6 weeks and 6 months
Change in acceptance of illness
Measured by a 5-item subscale of Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire
Measured: Baseline, 6 weeks and 6 months
Change in exercise self-efficacy
Measured by a question with a scale from 0 to 10; "0" indicates no exercise self-efficacy, while "10" indicates highest level of exercise self-efficacy.
Measured: Baseline, 6 weeks and 6 months
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, 6 weeks and 6 months
Change in grip strength
Measured by a dynamometer
Measured: Baseline, 6 weeks and 6 months
Change in lower limb strength
Measured by 30-second chair stand test.
Measured: Baseline, 6 weeks, and 6 months
Change in balance
Measured by single-leg-stance test
Measured: Baseline, 6 weeks and 6 months
Change in flexibility
Measured by chair sit and reach test
Measured: Baseline, 6 weeks, and 6 months
Change in objective physical activity levels, including duration, frequency and intensity
Measured by a waist-worn accelerometer
Measured: Baseline, 6 weeks, and 6 months
Change in sleep and wake intervals
Measured by watch-like activity monitor
Measured: Baseline, 6 weeks , and 6 months
Change in exercise capacity
Measured by a 6-min walk test
Measured: Baseline, 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 May 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 Experimental group will receive a brief SMART Exercise individual face-to-face session, and a package of information on lifestyle-integrated exercise and physical activity delivered through instant messaging and telephone calls. The Control group will receive a face-to-face individual session on general hygiene (GH) information, and a package of information on GH delivered through instant messaging and telephone calls.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Agnes Yuen-Kwan Lai, The University of Hong Kong
- Investigators
- Agnes YK Lai, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331391
- Sponsor's protocol ID
- UW21-148
- Status last verified
- May 2022
- First submitted
- 11 Apr 2022
- Last updated
- 1 Jun 2022
- 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
Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
PubMed 9095563Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Ho RT, Fong TC. Factor structure of the Chinese version of the Pittsburgh sleep quality index in breast cancer patients. Sleep Med. 2014 May;15(5):565-9. doi: 10.1016/j.sleep.2013.10.019. Epub 2014 Feb 18.
PubMed 24759325Koller M, Hjermstad MJ, Tomaszewski KA, Tomaszewska IM, Hornslien K, Harle A, Arraras JI, Morag O, Pompili C, Ioannidis G, Georgiou M, Navarra C, Chie WC, Johnson CD, Himpel A, Schulz C, Bohrer T, Janssens A, Kulis D, Bottomley A. An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients. Ann Oncol. 2017 Nov 1;28(11):2874-2881. doi: 10.1093/annonc/mdx453.
PubMed 28945875Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004 Feb;13(1):257-62. doi: 10.1023/B:QURE.0000015295.74812.06.
PubMed 15058806Nan H, Ni MY, Lee PH, Tam WW, Lam TH, Leung GM, McDowell I. Psychometric evaluation of the Chinese version of the Subjective Happiness Scale: evidence from the Hong Kong FAMILY Cohort. Int J Behav Med. 2014 Aug;21(4):646-52. doi: 10.1007/s12529-014-9389-3.
PubMed 24515396Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
PubMed 21624928Jones CJ, Rikli RE, Max J, Noffal G. The reliability and validity of a chair sit-and-reach test as a measure of hamstring flexibility in older adults. Res Q Exerc Sport. 1998 Dec;69(4):338-43. doi: 10.1080/02701367.1998.10607708.
PubMed 9864752Newton R. Review of tests of standing balance abilities. Brain Inj. 1989 Oct-Dec;3(4):335-43. doi: 10.3109/02699058909004558.
PubMed 2684312Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22.
PubMed 23700330Bonomi AG, Westerterp KR. Advances in physical activity monitoring and lifestyle interventions in obesity: a review. Int J Obes (Lond). 2012 Feb;36(2):167-77. doi: 10.1038/ijo.2011.99. Epub 2011 May 17.
PubMed 21587199Kushida CA, Chang A, Gadkary C, Guilleminault C, Carrillo O, Dement WC. Comparison of actigraphic, polysomnographic, and subjective assessment of sleep parameters in sleep-disordered patients. Sleep Med. 2001 Sep;2(5):389-96. doi: 10.1016/s1389-9457(00)00098-8.
PubMed 14592388
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Mobile SMART Exercise Support Program to Improve Fatigue in Patients With Advanced Lung Cancer - A Pragmatic Randomized Controlled Trial With Outcome and Process Evaluation
- ClinicalTrials.gov ID
- NCT05331391
- Acronym / sponsor ID
- UW21-148
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer (LC) is a common cancer in the world. Among all symptoms, Fatigue is considered as the most distressing medical condition of LC. Prior studies revealed that physical activity effectively relieve fatigue and related problems. The current study attempt to explore the effectiveness of SMART Exercise Support Program (SES) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (ALC) patients.
Detailed description
Lung cancer (LC) is the most and second most common cancer globally and locally, respectively. Nearly half of LC patients are diagnosed in the advanced stage. Fatigue is perceived to be the most distressing symptom. Physical activity has been proposed as an alternative treatment to relieve fatigue and related problems.
Mobile instant messaging applications (e.g. WhatsApp/WeChat) are popular and inexpensive for interactive messaging. A systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (PA), smoking cessation, and medication adherence.
The proposed randomized controlled trial (RCT) aims to examine the effectiveness of SES on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in ALC patients (SES group), compared to the General Hygiene Information (GHI, control) group.
Questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. Qualitative feedback will be obtained at the completion of the trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The Experimental group will receive a brief SMART Exercise individual face-to-face session, and a package of information on lifestyle-integrated exercise and physical activity delivered through instant messaging and telephone calls. The Control group will receive a face-to-face individual session on general hygiene (GH) information, and a package of information on GH delivered through instant messaging and telephone calls.
| Arm | Type | Receives |
|---|---|---|
| Brief mobile SMART Exercise Support Program | Experimental | Behavioral: Brief mobile SMART Exercise Support ProgramPatients will receive a brief SMART Exercise individual session with instant messages and telephone coaching for exercise habit formation and maintenance. |
| General Hygiene Information (GHI) | Placebo comparator | Behavioral: Brief mobile SMART Exercise Support ProgramPatients will receive an individual session, instant messages and telephone coaching regarding general hygiene information. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 years and above;
- Diagnosis of Stage III or IV non-small cell lung cancer;
- Edmonton Symptom Assessment System Scale fatigue symptom score ≥4 out of 10
- Self-reported engagement of <150 minutes of moderate intensity PA each week,
- Ambulatory and capable of all self-care activities (European Co-operative Oncology Group (ECOG) Performance Status of ≤2)
Key exclusion criteria (8 listed)
- Those preparing for lung operation;
- Skeletal fragility;
- Serious active infection;
- Inability to walk;
- Previously untreated symptomatic brain metastases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief mobile SMART Exercise Support ProgramPatients will receive 1) a brief SMART Exercise individual face-to-face session; 2) a theory-based instant messaging (WhatsApp/WeChat) and telephone-delivered health coaching on a 2-stage tapering schedule. Stage 1 (week 1 to 6): daily messages and two biweekly phone calls for exercise habit formation. Stage 2 (week 7 to 12): messages twice a week and monthly phone calls for exercise habit maintenance. | Behavioural | Brief mobile SMART Exercise Support Program, General Hygiene Information (GHI) |
Primary outcome
Change in fatigue level
Time frame: Baseline and 6 weeks
Measured by a 13-item Functional Assessment of Cancer Therapy - Fatigue subscale. The level of fatigue is measured on a five-point Likert scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue.
18 secondary outcomes
Change in fatigue level
Time frame: Baseline and 6 months
Change in anxiety symptoms
Time frame: Baseline, 6 weeks, 6 months
Change in depression symptoms
Time frame: Baseline, 6 weeks, 6 months
Change in physical activity level
Time frame: Baseline, 6 weeks, 6 months
Change in sleep quality
Time frame: Baseline, 6 weeks, 6 months
Change in health-related quality of life
Time frame: Baseline, 6 weeks, 6 months
Change in happiness level
Time frame: Baseline, 6 weeks, 6 months
Change in cancer-related symptoms
Time frame: Baseline, 6 weeks and 6 months
Change in acceptance of illness
Time frame: Baseline, 6 weeks and 6 months
Change in exercise self-efficacy
Time frame: Baseline, 6 weeks and 6 months
Change in social and family support
Time frame: Baseline, 6 weeks and 6 months
Change in grip strength
Time frame: Baseline, 6 weeks and 6 months
Change in lower limb strength
Time frame: Baseline, 6 weeks, and 6 months
Change in balance
Time frame: Baseline, 6 weeks and 6 months
Change in flexibility
Time frame: Baseline, 6 weeks, and 6 months
Change in objective physical activity levels, including duration, frequency and intensity
Time frame: Baseline, 6 weeks, and 6 months
Change in sleep and wake intervals
Time frame: Baseline, 6 weeks , and 6 months
Change in exercise capacity
Time frame: Baseline, 6 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Background: PubMed 9095563Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 24759325Ho RT, Fong TC. Factor structure of the Chinese version of the Pittsburgh sleep quality index in breast cancer patients. Sleep Med. 2014 May;15(5):565-9. doi: 10.1016/j.sleep.2013.10.019. Epub 2014 Feb 18.
- Background: PubMed 28945875Koller M, Hjermstad MJ, Tomaszewski KA, Tomaszewska IM, Hornslien K, Harle A, Arraras JI, Morag O, Pompili C, Ioannidis G, Georgiou M, Navarra C, Chie WC, Johnson CD, Himpel A, Schulz C, Bohrer T, Janssens A, Kulis D, Bottomley A. An international study to revise the EORTC questionnaire for assessing quality of life in lung cancer patients. Ann Oncol. 2017 Nov 1;28(11):2874-2881. doi: 10.1093/annonc/mdx453.
- Background: PubMed 15058806Chie WC, Yang CH, Hsu C, Yang PC. Quality of life of lung cancer patients: validation of the Taiwan Chinese version of the EORTC QLQ-C30 and QLQ-LC13. Qual Life Res. 2004 Feb;13(1):257-62. doi: 10.1023/B:QURE.0000015295.74812.06.
- Background: PubMed 24515396Nan H, Ni MY, Lee PH, Tam WW, Lam TH, Leung GM, McDowell I. Psychometric evaluation of the Chinese version of the Subjective Happiness Scale: evidence from the Hong Kong FAMILY Cohort. Int J Behav Med. 2014 Aug;21(4):646-52. doi: 10.1007/s12529-014-9389-3.
- Background: PubMed 21624928Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.
- Background: PubMed 9864752Jones CJ, Rikli RE, Max J, Noffal G. The reliability and validity of a chair sit-and-reach test as a measure of hamstring flexibility in older adults. Res Q Exerc Sport. 1998 Dec;69(4):338-43. doi: 10.1080/02701367.1998.10607708.
- Background: PubMed 2684312Newton R. Review of tests of standing balance abilities. Brain Inj. 1989 Oct-Dec;3(4):335-43. doi: 10.3109/02699058909004558.
- Background: PubMed 23700330Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22.
- Background: PubMed 21587199Bonomi AG, Westerterp KR. Advances in physical activity monitoring and lifestyle interventions in obesity: a review. Int J Obes (Lond). 2012 Feb;36(2):167-77. doi: 10.1038/ijo.2011.99. Epub 2011 May 17.
- Background: PubMed 14592388Kushida CA, Chang A, Gadkary C, Guilleminault C, Carrillo O, Dement WC. Comparison of actigraphic, polysomnographic, and subjective assessment of sleep parameters in sleep-disordered patients. Sleep Med. 2001 Sep;2(5):389-96. doi: 10.1016/s1389-9457(00)00098-8.
- Individual participant dataSharing planned: No. For those who want the patient data, please contact PI directly by written email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes YK Lai, PhD principal investigator
School of Nursing, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mobile SMART Exercise Support Program in people with Lung Cancer, run by The University of Hong Kong at 1 site 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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnes Lai, PhD (852-3917-6328, agneslai@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue level (time frame: Baseline and 6 weeks). 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 NCT05331391, which also lists 12 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 1 Jun 2022.