CancerNCT05050370
A Brief SMART Exercise Instant Messaging Support Intervention - a Pilot Study
A study testing Brief messaging and personalized support in people with Cancer and Lung, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Lung cancer is one of the most common cancer diseases, globally and locally. Several health benefits of increased physical activity (PA) have been reported for people with cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- Brief messaging and personalized support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Feb 2021to Dec 2021
- 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 non-small cell lung cancer or small cell lung cancer
- 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
- Either undergoing or finished oncology therapy and/or support care
Show all 11Show fewer
- Mentally, cognitively and physically fit to join the trial
- Able to speak and read Chinese;
- Willing to complete the patient-reported outcome questionnaire
- Completion of the Physical Activity Readiness Questionnaire
- 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
- Severe respiratory insufficiency
- Uncontrolled pain
- Diagnosed psychiatric illness 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, 3917-6283, agneslai@hku.hk
David Lam, PhD, 2255-4455, slnga@hku.hk
About this study
Official title: A Brief SMART Exercise With Chat-based Instant Messaging Personalised Support Intervention
Lung cancer is one of the most common cancer diseases, globally and locally. Several health benefits of increased physical activity (PA) have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Hence, the investigators propose to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise into daily activities of patients with lung cancer. The aims are to explore the feasibility of using instant messaging to enhance physical activity and improve their fatigue, emotion and quality of life, and obtain feedback from patients for intervention and study design improvement.
Read the detailed description
Lung cancer is one of the most common cancer, globally and locally. Patients with lung cancer are in a uniquely challenging situation in their disease, comorbidities, and treatment that may lead to worsened symptoms and many negative health consequences, including fatigue, irritability, and impaired daytime functioning. Physical activity (PA) is defined as 'any bodily movement produced by skeletal muscle that results in energy expenditure'. Several health benefits of increased PA have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to postdiagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Most clinicians underutilise exercise therapy, regardless of its low-cost way to improve symptoms and potential health outcomes. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Low motivation, fear to exercise, lack of knowledge about benefits are the most common barriers of engaging in physical activity for cancer patients.
Hence, the current proposal is to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise (light to moderate physical activity) into daily activities of patients with lung cancer.
The aims are to explore the feasibility of using instant messaging to enhance physical activity and improve their fatigue, emotion and quality of life, and obtain feedback from patients for intervention and study design improvement.
- Being tested
- Brief messaging and personalized support
- Keywords
- Lifestyle modification, physical activity, e-messages
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief messaging and personalized supportBehavioural
Patients will receive (i) a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise (including breathing, balance, aerobic, strength, stretching exercises), cancer-related care information and support.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle-integrated exercise and care support | Experimental | The experimental group will receive a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise and cancer-related information with personalized support. Receives: Behavioral: Brief messaging and personalized support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue level at 6 week
measured by Functional Assessment of Cancer Therapy - Fatigue subscale, the higher scores, the more fatigue.
Measured: Baseline and 6 weeks
Secondary outcomes (12)
Change in Anxiety and depressive symptoms at 6 weeks
measured by Hospital Anxiety and Depression Scale, Each item is answered on a 4-point scale (0-3). The scores for the seven questions on depression are added together to obtain a score ranged from 0 to 21. The higher score the more depressed. The scores for the seven questions on anxiety are added together to obtain a score ranged from 0 to 21. The higher score the more anxiety and depression symptoms.
Measured: Baseline and 6 weeks
Change in sleep quality at 6 weeks
measured by the Pittsburgh sleep quality index . The higher the score, the worse the quality.
Measured: Baseline and 6 weeks
Change in Health-related quality of life at 6 weeks
measured by the European Organization for Research and Treatment of Cancer and Lung Module. The higher scores the worse the quality.
Measured: Baseline and 6 weeks
Change in Subjective Happiness at 6 weeks
measured by Subjective Happiness Scale. The higher scores the more happy.
Measured: Baseline and 6 weeks
Change in Pain at 6 weeks
measured by a question with a scale from 0 to 10; a score of "0" indicates no pain at all, a score of "10" indicates severe pain. The higher score, the more pain.
Measured: Baseline and 6 weeks
Change in dyspnea at 6 weeks
measured by a question with a scale from 0 to 10; a score of "0" indicates no dyspnea at all, a score of "10" indicates severe dyspnea. The higher score, the more dyspnea.
Measured: Baseline and 6 weeks
Change in activity level at 6 weeks
measured by pedometer
Measured: Baseline and 6 weeks
Change in hand grip strength at 6 weeks
measured by a dynamometer
Measured: Baseline and 6 weeks
Change in balance at 6 weeks
measured by single leg stand test
Measured: Baseline and 6 weeks
Change in flexibility at 6 weeks
measured by chair sit and reach test
Measured: Baseline and 6 weeks
Change in sleep quality with objective measurement at 6 weeks
measured by activity monitor on duration of sleep and awake intervals
Measured: Baseline and 6 weeks
Change in physical activity level with objective measurement at 6 weeks
measured by accelerometer on the daily walking steps
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start4 Feb 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- The experimental group will receive a face-to-face group session and a package of information on lifestyle-integrated exercise and physical activity.
- Masking
- None (open label)
- Enrolment
- 16 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 Lai, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050370
- Sponsor's protocol ID
- UW20-019
- Status last verified
- Sep 2021
- First submitted
- 23 Jan 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For those who want the patients data, please contact PI directly by written email.
Publications
Gopalakrishnan S, Takemoto L; New Collective Author. Binding of actin to lens alpha crystallins. Curr Eye Res. 1992 Sep;11(9):929-33. doi: 10.3109/02713689209033490.
PubMed 1424733Peddle-McIntyre CJ, Singh F, Thomas R, Newton RU, Galvao DA, Cavalheri V. Exercise training for advanced lung cancer. Cochrane Database Syst Rev. 2019 Feb 11;2(2):CD012685. doi: 10.1002/14651858.CD012685.pub2.
PubMed 30741408
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief SMART Exercise With Chat-based Instant Messaging Personalised Support Intervention
- ClinicalTrials.gov ID
- NCT05050370
- Acronym / sponsor ID
- UW20-019
- Keywords
- Lifestyle modification, physical activity, e-messages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Sep 2021 (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 is one of the most common cancer diseases, globally and locally. Several health benefits of increased physical activity (PA) have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Hence, the investigators propose to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise into daily activities of patients with lung cancer. The aims are to explore the feasibility of using instant messaging to enhance physical activity and improve their fatigue, emotion and quality of life, and obtain feedback from patients for intervention and study design improvement.
Detailed description
Lung cancer is one of the most common cancer, globally and locally. Patients with lung cancer are in a uniquely challenging situation in their disease, comorbidities, and treatment that may lead to worsened symptoms and many negative health consequences, including fatigue, irritability, and impaired daytime functioning. Physical activity (PA) is defined as 'any bodily movement produced by skeletal muscle that results in energy expenditure'. Several health benefits of increased PA have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to postdiagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Most clinicians underutilise exercise therapy, regardless of its low-cost way to improve symptoms and potential health outcomes. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Low motivation, fear to exercise, lack of knowledge about benefits are the most common barriers of engaging in physical activity for cancer patients.
Hence, the current proposal is to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise (light to moderate physical activity) into daily activities of patients with lung cancer.
The aims are to explore the feasibility of using instant messaging to enhance physical activity and improve their fatigue, emotion and quality of life, and obtain feedback from patients for intervention and study design improvement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The experimental group will receive a face-to-face group session and a package of information on lifestyle-integrated exercise and physical activity.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle-integrated exercise and care support | Experimental | Behavioral: Brief messaging and personalized supportThe experimental group will receive a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise and cancer-related information with personalized support. |
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 non-small cell lung cancer or small cell lung cancer
- 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
Key exclusion criteria (7 listed)
- Those preparing for lung operation
- Skeletal fragility
- Serious active infection
- Inability to walk
- Severe respiratory insufficiency
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 messaging and personalized supportPatients will receive (i) a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise (including breathing, balance, aerobic, strength, stretching exercises), cancer-related care information and support. | Behavioural | Lifestyle-integrated exercise and care support |
Primary outcome
Change in fatigue level at 6 week
Time frame: Baseline and 6 weeks
measured by Functional Assessment of Cancer Therapy - Fatigue subscale, the higher scores, the more fatigue.
12 secondary outcomes
Change in Anxiety and depressive symptoms at 6 weeks
Time frame: Baseline and 6 weeks
Change in sleep quality at 6 weeks
Time frame: Baseline and 6 weeks
Change in Health-related quality of life at 6 weeks
Time frame: Baseline and 6 weeks
Change in Subjective Happiness at 6 weeks
Time frame: Baseline and 6 weeks
Change in Pain at 6 weeks
Time frame: Baseline and 6 weeks
Change in dyspnea at 6 weeks
Time frame: Baseline and 6 weeks
Change in activity level at 6 weeks
Time frame: Baseline and 6 weeks
Change in hand grip strength at 6 weeks
Time frame: Baseline and 6 weeks
Change in balance at 6 weeks
Time frame: Baseline and 6 weeks
Change in flexibility at 6 weeks
Time frame: Baseline and 6 weeks
Change in sleep quality with objective measurement at 6 weeks
Time frame: Baseline and 6 weeks
Change in physical activity level with objective measurement at 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Background: PubMed 1424733Gopalakrishnan S, Takemoto L; New Collective Author. Binding of actin to lens alpha crystallins. Curr Eye Res. 1992 Sep;11(9):929-33. doi: 10.3109/02713689209033490.
- Background: PubMed 30741408Peddle-McIntyre CJ, Singh F, Thomas R, Newton RU, Galvao DA, Cavalheri V. Exercise training for advanced lung cancer. Cochrane Database Syst Rev. 2019 Feb 11;2(2):CD012685. doi: 10.1002/14651858.CD012685.pub2.
- American Lung Association - Lung CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No. For those who want the patients 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 Lai, PhD principal investigator
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 messaging and personalized support in people with Cancer and Lung, 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 7 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 20 Sep 2021. 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. 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 at 6 week (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 NCT05050370, which also lists 2 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 20 Sep 2021.