ChildNCT02754973
Integrated Experiential Training Program With Coaching by Nursing Students in Childhood Cancer Patients
A study testing an integrated experiential training program with coaching in people with Child and Neoplasms, run by The University of Hong Kong at 1 site in China.
Trial summary
Background: Despite the evidence that regular physical activity can have beneficial effects on the physical and psychological well-being of cancer patients, a review of the literature reveals that a majority of young cancer patients fail to attain the same levels of physical activity that they had before contracting… Read more about this study
- Who is it for?
- Ages 9 to 18 years
- What is being tested?
- an integrated experiential training program with coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Nov 2017
- 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged between 9 to 18
- diagnosed with cancer at some time in the previous month and currently undergoing active treatments
- able to speak Cantonese and read Chinese
Who cannot join
- evidence of recurrence or second malignancies
- physical impairment or cognitive or learning problems identified from their medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Integrated Experiential Training Program With Coaching by Nursing Students in Promoting Regular Physical Activity and Reducing Fatigue Among Childhood Cancer Patients
Background: Despite the evidence that regular physical activity can have beneficial effects on the physical and psychological well-being of cancer patients, a review of the literature reveals that a majority of young cancer patients fail to attain the same levels of physical activity that they had before contracting the disease. There is scientific evidence that physical inactivity induces muscle catabolism and atrophy and cardiovascular diseases, which may lead to a further increase in fatigue and a decrease in the functional capacity of cancer patients. Empirical evidence is needed to explore an appropriate strategy for promoting physical activity in such patients.
Purposes: To examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.
Read more
Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated post-test, within and between subjects design will be conducted. Recruitment of subjects will be carried out in a paediatric oncology ward of a Hong Kong acute care hospital.
Intervention: Participants in the experimental group will join an integrated experiential training program with coaching by nursing students, which contains 28 home visits by a designated nursing student as a coach for a 6-month period. Those in the placebo control group will receive an amount of time and attention (home visits by research assistants) that mimics that received by the experimental group.
Read the detailed description
The aim of this study is to examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.
Intervention
Experimental group
During hospitalization for cancer treatment, besides receiving usual care, a registered nurse will deliver participants a health education talk. Participants will then be taught and encouraged to practice some simple stretching and relaxing exercises. After discharged from the hospital, participants in the experimental group are scheduled to take part in an integrated experiential training program with coaching by nursing students. Each participant is allocated to a nursing student who was voluntarily trained as coaches for the program. The intervention is implemented to each participant by the designated coach during 28 home visits throughout a 6-month period (24 weeks) and each visit lasts for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach pays a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. During the individual coaching sessions with the young people, the coaches will teach and demonstrate physical activities in 4 levels to the participants according to participants' ability.
Placebo control group
Since participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The activities during the home visits over a six-month period include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.
To ensure the dosage of intervention delivered in terms of the amount, frequency, duration, and breadth would be adequate to assess physical activity levels, physical activity self-efficacy, cancer-related fatigue, depression, muscle strength, and quality of life, a research committee is crucial to assess the dosage of the intervention and to train the volunteer nursing students as coaches for the intervention. In particular, the safety and appropriateness of the intervention content were reviewed carefully by the committee before commencement. The members in the committee consist of an associate professor, an assistant professor and a research student from a local university who are equipped with extensive experience in conducting different research and particularly, psychosocial interventions for children with cancer. The committee also includes a professor in paediatric oncology and a specialist nurse with substantial experience in delivering care to children undergoing cancer treatment, and an assistant professor who is an expert specialising in sports and recreation management.
Data Collection Methods
Approval for the study was obtained from the hospital ethics committees. To identify potential subjects, the research student approach to eligible children and their parents after screening the medical records in a paediatric oncology ward of a public acute care hospital in Hong Kong. After explaining the study details, including its purpose, procedures and potential harms and benefits, parents allowing their children to take part are required to sign a consent form. In addition, the children who are going to participate are invited to write down their names on a specially designed child assent form and told that their participation is voluntary.
Data collection for the outcome variables is conducted at the time of the subject recruitment (T1), and six (T2), and nine (T3) months after the start of the intervention, except that physical activity levels of childhood cancer patients are collected at the time of the subject recruitment (T1), and nine (T2) months after the start of the intervention. Before randomisation, participants are required to complete the hand grip strength test with the hand-held dynamometers (HHD) and fill in a set of questionnaires including CUHK-PARCY, the Chinese versions of PA-SE, fatigue scale, CES-DC, and PedsQL cancer module. Semi-structured interviews will also be carried out.
Analysis
The Statistical Package for Social Sciences (SPSS) software, version 21.0 for Windows will be used to analyze quantitative data. Intention-to-treat analysis will be used and missing data will be substituted by the last-observation-carried-forward procedure. The comparability of the experimental and control groups will be assessed by using inferential statistics (independent t-test and chi-squared test). Descriptive statistics will be used to calculate the mean scores and standard deviation of different scales. Mixed between-within subjects ANOVA (split-plot ANOVA) and post-hoc analysis using the Tukey procedure will be used to determine whether the integrated experiential training program with coaching by nursing students was effective in reducing fatigue, increasing childhood cancer patients' levels of physical activity, self-efficacy and muscle strength, decreasing depressive symptoms and enhancing their quality of life. Descriptive phenomenology will be employed during the process of qualitative data analysis.
- Being tested
- an integrated experiential training program with coaching, Placebo Control
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an integrated experiential training program with coachingBehavioural
The intervention will be implemented to each participant by a designated coach who is a trained nursing student during 28 home visits throughout a 6-month period (24 weeks) and each visit will last for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach will pay a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. 4 levels of physical activity will be taught to the participants gradually according to their ability.
Placebo ControlBehavioural
When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The placebo activities during the home visits may include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | During hospitalization for cancer treatment, besides receiving usual care, participants in the experimental group will first receive a health education talk Participants will then be taught and encouraged to practice with some stretching and relaxing exercises during their hospitalization. After hospitalization, participants will receive an integrated experiential training program with coaching by nursing students through home visits. Receives: Behavioral: an integrated experiential training program with coaching |
| Placebo Control group | Placebo comparator | Since participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. Receives: Behavioral: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of cancer-related fatigue from baseline at 9 month follow-up between intervention and control group
The primary outcomes are levels of cancer-related fatigue at 9 months after starting the intervention. The Chinese version of Fatigue Scale will be used to assess the fatigue of subjects.
Measured: 9 month follow-up
Secondary outcomes (16)
Levels of cancer-related fatigue at baseline
The Chinese version of Fatigue Scale will be used to assess the fatigue of subjects.
Measured: baseline
Change in cancer-related fatigue from baseline at 6 month follow-up between intervention and control group
The Chinese version of Fatigue Scale will be used to assess the fatigue of subjects.
Measured: 6 month follow-up
Levels of physical activity at baseline
The Chinese University of Hong Kong: Physical Activity Rating for Children and Youth (CUHK-PARCY) will be used to assess the physical activity levels of the participants. It contains only one item which was derived from the Jackson Activity Coding and the Godin-Shephard Activity Questionnaire Modified for Adolescents. Participants will be asked to respond to the Chinese version of the CUHK-PARCY before randomization.
Measured: baseline
Levels of physical activity self-efficacy at baseline
The Physical Activity Self-Efficacy (PA-SE) will be used to measure the children's self-confidence in their ability to participate in various age-appropriate physical activities. The PA-SE includes five items in which children are asked if they are 'not sure', 'a little sure' or 'very sure' that they can do such things as 'keep up a steady pace without stopping for 15-20 min'. Higher scores indicate higher self-efficacy. Participants will be asked to respond to the Chinese version of the PA-SE before randomization.
Measured: baseline
Change in levels of physical activity self-efficacy from baseline at 6 month follow-up
The Physical Activity Self-Efficacy (PA-SE) will be used to measure the children's self-confidence in their ability to participate in various age-appropriate physical activities. The PA-SE includes five items in which children are asked if they are 'not sure', 'a little sure' or 'very sure' that they can do such things as 'keep up a steady pace without stopping for 15-20 min'. Higher scores indicate higher self-efficacy. Participants will be asked to respond to the Chinese version of the PA-SE at 6 months after starting the intervention.
Measured: 6 month follow-up
Change in levels of physical activity self-efficacy from baseline at 9 month follow-up
The Physical Activity Self-Efficacy (PA-SE) will be used to measure the children's self-confidence in their ability to participate in various age-appropriate physical activities. The PA-SE includes five items in which children are asked if they are 'not sure', 'a little sure' or 'very sure' that they can do such things as 'keep up a steady pace without stopping for 15-20 min'. Higher scores indicate higher self-efficacy. Participants will be asked to respond to the Chinese version of the PA-SE at 9 months after starting the intervention.
Measured: 9 month follow-up
Depressive symptoms at baseline
The depressive symptoms will be measured by the Centre for Epidemiological Studies Depression Scale for Children (CES-DC). It consists of 20 items in which cancer patients rated their experience of the previous 7 days on a 4-point Likert scale (0 = 'not at all', 1 = 'a little', 2 = 'sometimes', 3 = 'a lot'). The scores range from 0 to 60 with 16 as the cut-off score to represent a significant level of depression in the children. Higher scores corresponds to more number of depressive symptoms. Participants will be asked to respond to the Chinese version of the CES-DC before randomization.
Measured: baseline
Change in depressive symptoms from baseline at 6 month follow-up
The depressive symptoms will be measured by the Centre for Epidemiological Studies Depression Scale for Children (CES-DC). It consists of 20 items in which cancer patients rated their experience of the previous 7 days on a 4-point Likert scale (0 = 'not at all', 1 = 'a little', 2 = 'sometimes', 3 = 'a lot'). The scores range from 0 to 60 with 16 as the cut-off score to represent a significant level of depression in the children. Higher scores corresponds to more number of depressive symptoms. Participants will be asked to respond to the Chinese version of the CES-DC at 6 months after starting the intervention.
Measured: 6 month follow-up
Change in depressive symptoms from baseline at 9 month follow-up
The depressive symptoms will be measured by the Centre for Epidemiological Studies Depression Scale for Children (CES-DC). It consists of 20 items in which cancer patients rated their experience of the previous 7 days on a 4-point Likert scale (0 = 'not at all', 1 = 'a little', 2 = 'sometimes', 3 = 'a lot'). The scores range from 0 to 60 with 16 as the cut-off score to represent a significant level of depression in the children. Higher scores corresponds to more number of depressive symptoms. Participants will be asked to respond to the Chinese version of the CES-DC at 9 months after starting the intervention.
Measured: 9 month follow-up
Muscle strength at baseline
The right- and left-hand grip strengths of the participants were assessed by a dynamometer before randomization.
Measured: basline
Change in muscle strength from baseline at 6 month follow-up between intervention and control group
The right- and left-hand grip strengths of the participants were assessed by a dynamometer 6 months after starting the intervention.
Measured: 6 month follow-up
Change in muscle strength from baseline at 9 month follow-up between intervention and control group
The right- and left-hand grip strengths of the participants were assessed by a dynamometer 9 months after starting the intervention.
Measured: 9 month follow-up
Levels of quality of life at baseline
The Quality of life of the participants will be measured by the Chinese version of the PedsQL cancer module v. 3.0. This scale consists of 27 items which are categorized into eight different subscales, namely pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (5 items), perceived physical appearance (3 items) and communication (3 items). All items are evaluated on 5-point Likert scale by which the participants will be asked how much of a problem has been experienced over the last month. Participants will be asked to respond to the Chinese version of the PedsQL cancer module v. 3.0 before randomization.
Measured: baseline
Change in levels of quality of life from baseline at 6 month follow-up between intervention and control group
The Quality of life of the participants will be measured by the Chinese version of the PedsQL cancer module v. 3.0. This scale consists of 27 items which are categorized into eight different subscales, namely pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (5 items), perceived physical appearance (3 items) and communication (3 items). All items are evaluated on 5-point Likert scale by which the participants will be asked how much of a problem has been experienced over the last month. Participants will be asked to respond to the Chinese version of the PedsQL cancer module v. 3.0 at 6 months after starting the intervention.
Measured: 6 month follow-up
Change in levels of quality of life from baseline at 9 month follow-up between intervention and control group
The Quality of life of the participants will be measured by the Chinese version of the PedsQL cancer module v. 3.0. This scale consists of 27 items which are categorized into eight different subscales, namely pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (5 items), perceived physical appearance (3 items) and communication (3 items). All items are evaluated on 5-point Likert scale by which the participants will be asked how much of a problem has been experienced over the last month. Participants will be asked to respond to the Chinese version of the PedsQL cancer module v. 3.0 at 9 months after starting the intervention.
Measured: 9 month follow-up
Change in levels of physical activity from baseline at 9 month follow-up between intervention and control group
The Chinese University of Hong Kong: Physical Activity Rating for Children and Youth (CUHK-PARCY) will be used to assess the physical activity levels of the participants. It contains only one item which was derived from the Jackson Activity Coding and the Godin-Shephard Activity Questionnaire Modified for Adolescents. Participants will be asked to respond to the Chinese version of the CUHK-PARCY at 9 months after starting the intervention.
Measured: 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754973
- Sponsor's protocol ID
- UW15-219
- Status last verified
- Jun 2018
- First submitted
- 19 Apr 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lam KKW, Li WHC, Chung OK, Ho KY, Chiu SY, Lam HS, Chan GCF. An integrated experiential training programme with coaching to promote physical activity, and reduce fatigue among children with cancer: A randomised controlled trial. Patient Educ Couns. 2018 Nov;101(11):1947-1956. doi: 10.1016/j.pec.2018.07.008. Epub 2018 Jul 7.
PubMed 30007765
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Experiential Training Program With Coaching by Nursing Students in Promoting Regular Physical Activity and Reducing Fatigue Among Childhood Cancer Patients
- ClinicalTrials.gov ID
- NCT02754973
- Acronym / sponsor ID
- UW15-219
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Apr 2016 (estimated)
- 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.
Background: Despite the evidence that regular physical activity can have beneficial effects on the physical and psychological well-being of cancer patients, a review of the literature reveals that a majority of young cancer patients fail to attain the same levels of physical activity that they had before contracting the disease. There is scientific evidence that physical inactivity induces muscle catabolism and atrophy and cardiovascular diseases, which may lead to a further increase in fatigue and a decrease in the functional capacity of cancer patients. Empirical evidence is needed to explore an appropriate strategy for promoting physical activity in such patients.
Purposes: To examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.
Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated post-test, within and between subjects design will be conducted. Recruitment of subjects will be carried out in a paediatric oncology ward of a Hong Kong acute care hospital.
Intervention: Participants in the experimental group will join an integrated experiential training program with coaching by nursing students, which contains 28 home visits by a designated nursing student as a coach for a 6-month period. Those in the placebo control group will receive an amount of time and attention (home visits by research assistants) that mimics that received by the experimental group.
Detailed description
The aim of this study is to examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.
Intervention
Experimental group
During hospitalization for cancer treatment, besides receiving usual care, a registered nurse will deliver participants a health education talk. Participants will then be taught and encouraged to practice some simple stretching and relaxing exercises. After discharged from the hospital, participants in the experimental group are scheduled to take part in an integrated experiential training program with coaching by nursing students. Each participant is allocated to a nursing student who was voluntarily trained as coaches for the program. The intervention is implemented to each participant by the designated coach during 28 home visits throughout a 6-month period (24 weeks) and each visit lasts for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach pays a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. During the individual coaching sessions with the young people, the coaches will teach and demonstrate physical activities in 4 levels to the participants according to participants' ability.
Placebo control group
Since participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The activities during the home visits over a six-month period include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.
To ensure the dosage of intervention delivered in terms of the amount, frequency, duration, and breadth would be adequate to assess physical activity levels, physical activity self-efficacy, cancer-related fatigue, depression, muscle strength, and quality of life, a research committee is crucial to assess the dosage of the intervention and to train the volunteer nursing students as coaches for the intervention. In particular, the safety and appropriateness of the intervention content were reviewed carefully by the committee before commencement. The members in the committee consist of an associate professor, an assistant professor and a research student from a local university who are equipped with extensive experience in conducting different research and particularly, psychosocial interventions for children with cancer. The committee also includes a professor in paediatric oncology and a specialist nurse with substantial experience in delivering care to children undergoing cancer treatment, and an assistant professor who is an expert specialising in sports and recreation management.
Data Collection Methods
Approval for the study was obtained from the hospital ethics committees. To identify potential subjects, the research student approach to eligible children and their parents after screening the medical records in a paediatric oncology ward of a public acute care hospital in Hong Kong. After explaining the study details, including its purpose, procedures and potential harms and benefits, parents allowing their children to take part are required to sign a consent form. In addition, the children who are going to participate are invited to write down their names on a specially designed child assent form and told that their participation is voluntary.
Data collection for the outcome variables is conducted at the time of the subject recruitment (T1), and six (T2), and nine (T3) months after the start of the intervention, except that physical activity levels of childhood cancer patients are collected at the time of the subject recruitment (T1), and nine (T2) months after the start of the intervention. Before randomisation, participants are required to complete the hand grip strength test with the hand-held dynamometers (HHD) and fill in a set of questionnaires including CUHK-PARCY, the Chinese versions of PA-SE, fatigue scale, CES-DC, and PedsQL cancer module. Semi-structured interviews will also be carried out.
Analysis
The Statistical Package for Social Sciences (SPSS) software, version 21.0 for Windows will be used to analyze quantitative data. Intention-to-treat analysis will be used and missing data will be substituted by the last-observation-carried-forward procedure. The comparability of the experimental and control groups will be assessed by using inferential statistics (independent t-test and chi-squared test). Descriptive statistics will be used to calculate the mean scores and standard deviation of different scales. Mixed between-within subjects ANOVA (split-plot ANOVA) and post-hoc analysis using the Tukey procedure will be used to determine whether the integrated experiential training program with coaching by nursing students was effective in reducing fatigue, increasing childhood cancer patients' levels of physical activity, self-efficacy and muscle strength, decreasing depressive symptoms and enhancing their quality of life. Descriptive phenomenology will be employed during the process of qualitative data analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: an integrated experiential training program with coachingDuring hospitalization for cancer treatment, besides receiving usual care, participants in the experimental group will first receive a health education talk Participants will then be taught and encouraged to practice with some stretching and relaxing exercises during their hospitalization. After hospitalization, participants will receive an integrated experiential training program with coaching by nursing students through home visits. |
| Placebo Control group | Placebo comparator | Behavioral: Placebo ControlSince participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- aged between 9 to 18
- diagnosed with cancer at some time in the previous month and currently undergoing active treatments
- able to speak Cantonese and read Chinese
Key exclusion criteria (2 listed)
- evidence of recurrence or second malignancies
- physical impairment or cognitive or learning problems identified from their medical records
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 |
|---|---|---|
| an integrated experiential training program with coachingThe intervention will be implemented to each participant by a designated coach who is a trained nursing student during 28 home visits throughout a 6-month period (24 weeks) and each visit will last for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach will pay a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. 4 levels of physical activity will be taught to the participants gradually according to their ability. | Behavioural | Experimental group |
| Placebo ControlWhen discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The placebo activities during the home visits may include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit. | Behavioural | Placebo Control group |
Primary outcome
Change in levels of cancer-related fatigue from baseline at 9 month follow-up between intervention and control group
Time frame: 9 month follow-up
The primary outcomes are levels of cancer-related fatigue at 9 months after starting the intervention. The Chinese version of Fatigue Scale will be used to assess the fatigue of subjects.
16 secondary outcomes
Levels of cancer-related fatigue at baseline
Time frame: baseline
Change in cancer-related fatigue from baseline at 6 month follow-up between intervention and control group
Time frame: 6 month follow-up
Levels of physical activity at baseline
Time frame: baseline
Levels of physical activity self-efficacy at baseline
Time frame: baseline
Change in levels of physical activity self-efficacy from baseline at 6 month follow-up
Time frame: 6 month follow-up
Change in levels of physical activity self-efficacy from baseline at 9 month follow-up
Time frame: 9 month follow-up
Depressive symptoms at baseline
Time frame: baseline
Change in depressive symptoms from baseline at 6 month follow-up
Time frame: 6 month follow-up
Change in depressive symptoms from baseline at 9 month follow-up
Time frame: 9 month follow-up
Muscle strength at baseline
Time frame: basline
Change in muscle strength from baseline at 6 month follow-up between intervention and control group
Time frame: 6 month follow-up
Change in muscle strength from baseline at 9 month follow-up between intervention and control group
Time frame: 9 month follow-up
Levels of quality of life at baseline
Time frame: baseline
Change in levels of quality of life from baseline at 6 month follow-up between intervention and control group
Time frame: 6 month follow-up
Change in levels of quality of life from baseline at 9 month follow-up between intervention and control group
Time frame: 9 month follow-up
Change in levels of physical activity from baseline at 9 month follow-up between intervention and control group
Time frame: 9 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Derived from this study: PubMed 30007765Lam KKW, Li WHC, Chung OK, Ho KY, Chiu SY, Lam HS, Chan GCF. An integrated experiential training programme with coaching to promote physical activity, and reduce fatigue among children with cancer: A randomised controlled trial. Patient Educ Couns. 2018 Nov;101(11):1947-1956. doi: 10.1016/j.pec.2018.07.008. Epub 2018 Jul 7.
- Individual participant dataSharing planned: No
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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.
Ho Cheung William Li 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 an integrated experiential training program with coaching in people with Child and Neoplasms, run by The University of Hong Kong at 1 site in China.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 Jun 2018. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of cancer-related fatigue from baseline at 9 month follow-up between intervention and control group (time frame: 9 month 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 NCT02754973, which also lists 1 linked publication.
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 11 Jun 2018.