Malignant Childhood NeoplasmNCT01803672
Effectiveness of an Integrated Programme in Promoting the Regular Physical Activity Among Childhood Cancer Survivors
A study testing health talk and adventure-based training in people with Malignant Childhood Neoplasm, run by The University of Hong Kong at 1 site in China.
Trial summary
Background.There is some evidence that engaging in regular moderate-intensity physical activity may help ameliorate cancer-related fatigue experienced by childhood cancer survivors, which eventually improve their quality of life. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Childhood Neoplasm
- What is being tested?
- health talk and adventure-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jan 2013
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Hong Kong Chinese childhood cancer survivors defined here as having completed treatment at least six months previously
- between 7 and 18 years of age
- able to speak Cantonese and read Chinese
- did not engage in regular physical activity for the past 6 months
Who cannot join
- childhood cancer survivors with evidence of recurrence or second malignancies
- those with physical impairment or cognitive and 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 Adventure-Based Training and Health Education Programme in Promoting the Adoption and Maintenance of Regular Physical Activity Among Childhood Cancer Survivors
Background.There is some evidence that engaging in regular moderate-intensity physical activity may help ameliorate cancer-related fatigue experienced by childhood cancer survivors, which eventually improve their quality of life. Nevertheless, there is growing concern about declining levels of physical activity in childhood cancer survivors.
Purposes. To examine the effectiveness of an integrated adventure-based training and health education programme in promoting the adoption and maintenance of regular physical activity, reducing fatigue and improving the quality of life among Hong Kong Chinese childhood cancer survivors.
Read more
Design and Subjects. A randomised controlled trial (RCT), two-group pre-test and repeated post-test, between subjects design was conducted. Recruitment of subjects was carried out through the Sunshine Parents Club, which is a non-profit voluntary organization with the aim to provide education and psychological support to parents of Hong Kong Chinese childhood cancer survivors.
Intervention. Participants in the placebo control group received an amount of time and attention (leisure activities organized by a community centre) that mimicked that received by the experimental group. Participants in the experimental group joined a four-day integrated adventure-based training and health education programme, which contained education talks, a workshop and adventure-based training activities.
Read the detailed description
The aim of this study was to examine the effectiveness of an integrated adventure-based training and health education programme in promoting the exercise behavior changes, enhancing the physical activity levels, self-efficacy, reducing fatigue and improving the quality of life of Hong Kong Chinese childhood cancer survivors.
Intervention
Placebo control group
Participants received medical follow-up according to the schedule of the oncology units. Besides, participants received an amount of time and attention that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. They were invited to attend leisure activities organized by a community centre in four different days during the study period. Activities included cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park.
Experimental group
Besides receiving medical follow-up, participants joined a four-day integrated adventure-based training and health education programme, which contains education talks, a workshop to work out a feasible individual action plan for regular physical activity and adventure-based training activities. Previous research showed that working out individual action plan is important, which can increase the possibility for people to turn their intentions into health promotion action. The content of the education talks were tailor-made for participants in which they did not engage in regular physical activity.
To ensure the dosage of intervention delivered in terms of the amount, frequency, duration, and breadth would be adequate to assess the quality and to manage outcomes, such as physical activity levels, self-efficacy, stages of change and quality of life, the following measures were taken. An advisory committee was set up with the purpose to develop an appropriate integrated programme for Hong Kong Chinese childhood cancer survivors. The committee included the researcher, an assistant professor at a local university with considerable experience of conducting psychological interventions among children, a paediatric oncologist and a oncology nurse specialist with rich experience in taking care of children with cancer, two professional adventure-based trainers and one assistant professor of Sports and Recreation Management with extensive experience and professional knowledge in conducting adventure-based training for children. In addition, the content of the programme that related to adventure-based training activities was sent to a professional adventure-based training centre for content validation. The programme was implemented on four different days within six months in a day camp training centre, such as at 2-week, 2-month, 4-month and 6-month after the day of recruitment. The programme was implemented in small group with maximum 12 participants in one group. Health education talks and workshop were implemented in between adventure-based training activities in day camp centre, which were conducted by healthcare professionals working in a local university. Adventure-based training activities were led by two qualified adventure-based training instructors with extensive experience and professional knowledge in conducting such training for children. Additionally, at least two healthcare professionals joined the adventure-based training to monitor the physical condition of the survivors and their fitness to join the adventure-based training activities.
Data Collection Methods
Data Collection Methods Approval for the study was obtained from the hospital ethics committees. To identify potential subjects, a leaflet containing details of the study and a demographic sheet have been mailed to all parents of childhood cancer survivors in the Sunshine Parents Club. If children and their parents are interested in the research, they can return the demographic sheet by using the enclosed return-envelop to convey their willingness to participate in the study. A briefing session will then be conducted in the out-patient clinic to those eligible children and parents. Written consent has been obtained from the parents after they were told the purposes of the study, although they were of course given the option of allowing or refusing the involvement of their child. The children has also been invited to put their names on a special children's assent form and told that their participation is voluntary.
After obtaining demographic data of participants, they have been asked to respond to the Chinese version of the FS-C/FS-A, PA-SE, CUHK-PARCY, PASCQ and PedsQL. They have also been assessed for muscle strength using a hand-held dynamometer. Participants have been randomly assigned to the experimental and control groups. All participants received a telephone call inviting them to join the interventions according to their group assignment at an appointed time. Data collection has been conducted again at 3, 6, 9 and 12 months after starting the intervention. All participants has been informed that there would be home visits for data collection.
Analysis
The Statistical Package for Social Sciences (SPSS) software, version 19.0 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) will be used to determine whether the adventure-based training programme was effective in reducing fatigue, increasing childhood cancer survivors' levels of physical activity, self-efficacy and muscle strength and enhancing their quality of life. In addition, Friedman Test will be used to determine any changes in stages of change between the experimental and control groups.
- Conditions
- Malignant Childhood Neoplasm
- Being tested
- health talk and adventure-based training, Placebo control
- Keywords
- Adventure-Based training, Health education, childhood cancer, physical activity
- Medical subject headings
- Neoplasms, Health Education, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health talk and adventure-based trainingBehavioural
To develop an integrated programme for Hong Kong Chinese childhood cancer survivors, an advisory committee was set up which included the three healthcare professionals (researchers), two school principals, two professional adventure-based trainers and one assistant professor of Sports and Recreation Management, ensuring the adequate 'dosage' of the intervention and the feasibility of implementing such programme for Hong Kong childhood cancer surviviors.
Placebo controlBehavioural
They will be invited to attend leisure activities organized by a community centre in four different days during the study period. Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park.
| Study group | Role | What they receive |
|---|---|---|
| health talk and adventure-based training | Experimental | Participate will join a four-day integrated health education and adventure-based training programme, which contains education talks, workshop and adventure-based training activities. The programme will be implemented on four different days within six months in a day camp training centre. The integrated programme will be implemented in small group with maximum 15 participants in one group. Health education talks and workshop will be implemented in between adventure-based training activities in day camp centre, which will be conducted by healthcare professionals working in a local university. Receives: Behavioral: health talk and adventure-based training |
| Placebo Control | Placebo comparator | Participants will receive an amount of time and attention that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. They will be invited to attend leisure activities organized by a community centre in four different days during the study period. Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park. 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 6-month follow-up between intervention and control group
The primary outcomes are levels of cancer-related fatigue at 6 months after starting the intervention among the two groups. The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old. For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
Measured: 6-month follow-up
Secondary outcomes (29)
change in levels of cancer-related fatigue from baseline at 3-month follow-up between intervention and control group
The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old. For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
Measured: 3-month follow-up
change in levels of cancer-related fatigue from baseline at 9-month follow-up between intervention and control group
The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old. For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
Measured: 9-month follow-up
change in levels of cancer-related fatigue from baseline at 12-month follow-up between intervention and control group
The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old. For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
Measured: 12-months follow-up
levels of cancer-related fatigue at Baseline
The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old. For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
Measured: Baseline
change in physical activity levels from baseline at 6-month follow-up between intervention and control group
The physical activity levels of participants will be assessed using the CUHK-PARCY, which is an 11-item activity rating modified from the Jackson Activity Coding and the Godin-Shephard Activity Questionnaire Modified for Adolescents. Participant will be asked to respond to the Chinese version of the CUHK-PARCY at 6 months after starting the intervention.
Measured: 6-month follow-up
change in physical activity levels from baseline at 3-month follow-up between intervention and control group
The physical activity levels of participants will be assessed using the CUHK-PARCY, which is an 11-item activity rating modified from the Jackson Activity Coding and the Godin-Shephard Activity Questionnaire Modified for Adolescents. Participant will be asked to respond to the Chinese version of the CUHK-PARCY at 6 months after starting the intervention.
Measured: 3-month follow-up
change in physical activity levels from baseline at 9-month follow-up between intervention and control group
The physical activity levels of participants will be assessed using the CUHK-PARCY, which is an 11-item activity rating modified from the Jackson Activity Coding and the Godin-Shephard Activity Questionnaire Modified for Adolescents. Participant 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
change in physical activity levels from baseline at 12-month follow-up between intervention and control group
The physical activity levels of participants will be assessed using the CUHK-PARCY, which is an 11-item activity rating modified from the Jackson Activity Coding and the Godin-Shephard Activity Questionnaire Modified for Adolescents. Participant will be asked to respond to the Chinese version of the CUHK-PARCY at 12 months after starting the intervention.
Measured: 12-month follow-up
Physical activity levels activity at Baseline
The physical activity levels of participants will be assessed using the CUHK-PARCY, which is an 11-item activity rating modified 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
Stages of Change at baseline
The current stages of exercising patterns for participants will be evaluated by an adapted version of PASCQ. It is a binary type (yes/no) questionnaire, and contains four items. Participants will answer each question about their physical activity practices with a 'yes' or a 'no'. According to these responses, they will be classified into five different stages by means of a scoring algorithm. Participant will be asked to respond to the Chinese version of the PASCQ before the randomization.
Measured: Baseline
change in stages of change from baseline at 3-month follow-up between intervention and control group
The current stages of exercising patterns for participants will be evaluated by an adapted version of PASCQ. It is a binary type (yes/no) questionnaire, and contains four items. Participants will answer each question about their physical activity practices with a 'yes' or a 'no'. According to these responses, they will be classified into five different stages by means of a scoring algorithm. Participant will be asked to respond to the Chinese version of the PASCQ 3 months after starting the intervention.
Measured: 3-month follow up
change in stages of change from baseline at 6-month follow-up between intervention and control group
The current stages of exercising patterns for participants will be evaluated by an adapted version of PASCQ. It is a binary type (yes/no) questionnaire, and contains four items. Participants will answer each question about their physical activity practices with a 'yes' or a 'no'. According to these responses, they will be classified into five different stages by means of a scoring algorithm. Participant will be asked to respond to the Chinese version of the PASCQ 6 months after starting the intervention.
Measured: 6-month follow up
change in stages of change from baseline at 9-month follow-up between intervention and control group
The current stages of exercising patterns for participants will be evaluated by an adapted version of PASCQ. It is a binary type (yes/no) questionnaire, and contains four items. Participants will answer each question about their physical activity practices with a 'yes' or a 'no'. According to these responses, they will be classified into five different stages by means of a scoring algorithm. Participant will be asked to respond to the Chinese version of the PASCQ 9 months after starting the intervention.
Measured: 9-month follow up
change in stages of change from baseline at 12-month follow-up between intervention and control group
The current stages of exercising patterns for participants will be evaluated by an adapted version of PASCQ. It is a binary type (yes/no) questionnaire, and contains four items. Participants will answer each question about their physical activity practices with a 'yes' or a 'no'. According to these responses, they will be classified into five different stages by means of a scoring algorithm. Participant will be asked to respond to the Chinese version of the PASCQ 12 months after starting the intervention.
Measured: 12-month follow up
physical activity self-efficacy at baseline
The 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 such 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 the randomization.
Measured: baseline
change in physical activity self-efficacy from baseline at 3-month follow-up between intervention and control group
The 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 such 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 3 months after starting the intervention.
Measured: 3-month follow up
change in physical activity self-efficacy from baseline at 6-month follow-up between intervention and control group
The 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 such 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 6 months after starting the intervention.
Measured: 6-month follow up
change in physical activity self-efficacy from baseline at 9-month follow-up between intervention and control group
The 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 such 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 9 months after starting the intervention.
Measured: 9-month follow up
change in physical activity self-efficacy from baseline at 12-month follow-up between intervention and control group
The 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 such 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 12 months after starting the intervention.
Measured: 12-month follow up
quality of life at baseline
The PedsQL will be used to measure quality of life among childhood cancer survivors. The instrument comprises 23 items grouped into four subscales: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). Participants will be asked how much of a problem has been experienced over the last month, with rating from 0 to 4. Higher scores indicate better quality of life. Participant will be asked to respond to the Chinese version of the PedsQL before the randomization.
Measured: baseline
change in quality of life from baseline at 3-month follow-up between intervention and control group
The PedsQL will be used to measure quality of life among childhood cancer survivors. The instrument comprises 23 items grouped into four subscales: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). Participants will be asked how much of a problem has been experienced over the last month, with rating from 0 to 4. Higher scores indicate better quality of life. Participant will be asked to respond to the Chinese version of the PedsQL 3 months after starting the intervention.
Measured: 3-month follow up
change in quality of life from baseline at 6-month follow-up between intervention and control group
The PedsQL will be used to measure quality of life among childhood cancer survivors. The instrument comprises 23 items grouped into four subscales: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). Participants will be asked how much of a problem has been experienced over the last month, with rating from 0 to 4. Higher scores indicate better quality of life. Participant will be asked to respond to the Chinese version of the PedsQL 6 months after starting the intervention.
Measured: 6-month follow up
change in quality of life from baseline at 9-month follow-up between intervention and control group
The PedsQL will be used to measure quality of life among childhood cancer survivors. The instrument comprises 23 items grouped into four subscales: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). Participants will be asked how much of a problem has been experienced over the last month, with rating from 0 to 4. Higher scores indicate better quality of life. Participant will be asked to respond to the Chinese version of the PedsQL 9 months after starting the intervention.
Measured: 9-month follow up
change in quality of life from baseline at 12-month follow-up between intervention and control group
The PedsQL will be used to measure quality of life among childhood cancer survivors. The instrument comprises 23 items grouped into four subscales: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and school functioning (5 items). Participants will be asked how much of a problem has been experienced over the last month, with rating from 0 to 4. Higher scores indicate better quality of life. Participant will be asked to respond to the Chinese version of the PedsQL 12 months after starting the intervention.
Measured: 12-month follow up
muscle strength at baseline
the isokinetic strength of muscles will be measured by a dynamometer using a break and make technique before randomization.
Measured: baseline
change in muscle strength from baseline at 3-month follow-up between intervention and control group
The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 3 months after starting the intervention.
Measured: 3-month follow up
change in muscle strength from baseline at 6-month follow-up between intervention and control group
The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 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 isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 9 months after starting the intervention.
Measured: 9-month follow up
change in muscle strength from baseline at 12-month follow-up between intervention and control group
The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 12 months after starting the intervention.
Measured: 12-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 posted4 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Childhood NeoplasmStudies 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
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Ho Cheung Li, PhD, Principal investigator, The School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803672
- Sponsor's protocol ID
- 102009189
- Status last verified
- Apr 2016
- First submitted
- 26 Feb 2013
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Adventure-Based Training and Health Education Programme in Promoting the Adoption and Maintenance of Regular Physical Activity Among Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT01803672
- Acronym / sponsor ID
- 102009189
- Conditions
- Malignant Childhood Neoplasm
- Keywords
- Adventure-Based training, Health education, childhood cancer, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Mar 2013 (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.There is some evidence that engaging in regular moderate-intensity physical activity may help ameliorate cancer-related fatigue experienced by childhood cancer survivors, which eventually improve their quality of life. Nevertheless, there is growing concern about declining levels of physical activity in childhood cancer survivors.
Purposes. To examine the effectiveness of an integrated adventure-based training and health education programme in promoting the adoption and maintenance of regular physical activity, reducing fatigue and improving the quality of life among Hong Kong Chinese childhood cancer survivors.
Design and Subjects. A randomised controlled trial (RCT), two-group pre-test and repeated post-test, between subjects design was conducted. Recruitment of subjects was carried out through the Sunshine Parents Club, which is a non-profit voluntary organization with the aim to provide education and psychological support to parents of Hong Kong Chinese childhood cancer survivors.
Intervention. Participants in the placebo control group received an amount of time and attention (leisure activities organized by a community centre) that mimicked that received by the experimental group. Participants in the experimental group joined a four-day integrated adventure-based training and health education programme, which contained education talks, a workshop and adventure-based training activities.
Detailed description
The aim of this study was to examine the effectiveness of an integrated adventure-based training and health education programme in promoting the exercise behavior changes, enhancing the physical activity levels, self-efficacy, reducing fatigue and improving the quality of life of Hong Kong Chinese childhood cancer survivors.
Intervention
Placebo control group
Participants received medical follow-up according to the schedule of the oncology units. Besides, participants received an amount of time and attention that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. They were invited to attend leisure activities organized by a community centre in four different days during the study period. Activities included cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park.
Experimental group
Besides receiving medical follow-up, participants joined a four-day integrated adventure-based training and health education programme, which contains education talks, a workshop to work out a feasible individual action plan for regular physical activity and adventure-based training activities. Previous research showed that working out individual action plan is important, which can increase the possibility for people to turn their intentions into health promotion action. The content of the education talks were tailor-made for participants in which they did not engage in regular physical activity.
To ensure the dosage of intervention delivered in terms of the amount, frequency, duration, and breadth would be adequate to assess the quality and to manage outcomes, such as physical activity levels, self-efficacy, stages of change and quality of life, the following measures were taken. An advisory committee was set up with the purpose to develop an appropriate integrated programme for Hong Kong Chinese childhood cancer survivors. The committee included the researcher, an assistant professor at a local university with considerable experience of conducting psychological interventions among children, a paediatric oncologist and a oncology nurse specialist with rich experience in taking care of children with cancer, two professional adventure-based trainers and one assistant professor of Sports and Recreation Management with extensive experience and professional knowledge in conducting adventure-based training for children. In addition, the content of the programme that related to adventure-based training activities was sent to a professional adventure-based training centre for content validation. The programme was implemented on four different days within six months in a day camp training centre, such as at 2-week, 2-month, 4-month and 6-month after the day of recruitment. The programme was implemented in small group with maximum 12 participants in one group. Health education talks and workshop were implemented in between adventure-based training activities in day camp centre, which were conducted by healthcare professionals working in a local university. Adventure-based training activities were led by two qualified adventure-based training instructors with extensive experience and professional knowledge in conducting such training for children. Additionally, at least two healthcare professionals joined the adventure-based training to monitor the physical condition of the survivors and their fitness to join the adventure-based training activities.
Data Collection Methods
Data Collection Methods Approval for the study was obtained from the hospital ethics committees. To identify potential subjects, a leaflet containing details of the study and a demographic sheet have been mailed to all parents of childhood cancer survivors in the Sunshine Parents Club. If children and their parents are interested in the research, they can return the demographic sheet by using the enclosed return-envelop to convey their willingness to participate in the study. A briefing session will then be conducted in the out-patient clinic to those eligible children and parents. Written consent has been obtained from the parents after they were told the purposes of the study, although they were of course given the option of allowing or refusing the involvement of their child. The children has also been invited to put their names on a special children's assent form and told that their participation is voluntary.
After obtaining demographic data of participants, they have been asked to respond to the Chinese version of the FS-C/FS-A, PA-SE, CUHK-PARCY, PASCQ and PedsQL. They have also been assessed for muscle strength using a hand-held dynamometer. Participants have been randomly assigned to the experimental and control groups. All participants received a telephone call inviting them to join the interventions according to their group assignment at an appointed time. Data collection has been conducted again at 3, 6, 9 and 12 months after starting the intervention. All participants has been informed that there would be home visits for data collection.
Analysis
The Statistical Package for Social Sciences (SPSS) software, version 19.0 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) will be used to determine whether the adventure-based training programme was effective in reducing fatigue, increasing childhood cancer survivors' levels of physical activity, self-efficacy and muscle strength and enhancing their quality of life. In addition, Friedman Test will be used to determine any changes in stages of change between the experimental and control groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health talk and adventure-based training | Experimental | Behavioral: health talk and adventure-based trainingParticipate will join a four-day integrated health education and adventure-based training programme, which contains education talks, workshop and adventure-based training activities. The programme will be implemented on four different days within six months in a day camp training centre. The integrated programme will be implemented in small group with maximum 15 participants in one group. Health education talks and workshop will be implemented in between adventure-based training activities in day camp centre, which will be conducted by healthcare professionals working in a local university. |
| Placebo Control | Placebo comparator | Behavioral: Placebo controlParticipants will receive an amount of time and attention that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. They will be invited to attend leisure activities organized by a community centre in four different days during the study period. Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Hong Kong Chinese childhood cancer survivors defined here as having completed treatment at least six months previously
- between 7 and 18 years of age
- able to speak Cantonese and read Chinese
- did not engage in regular physical activity for the past 6 months
Key exclusion criteria (2 listed)
- childhood cancer survivors with evidence of recurrence or second malignancies
- those with physical impairment or cognitive and 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 |
|---|---|---|
| health talk and adventure-based trainingTo develop an integrated programme for Hong Kong Chinese childhood cancer survivors, an advisory committee was set up which included the three healthcare professionals (researchers), two school principals, two professional adventure-based trainers and one assistant professor of Sports and Recreation Management, ensuring the adequate 'dosage' of the intervention and the feasibility of implementing such programme for Hong Kong childhood cancer surviviors. | Behavioural | health talk and adventure-based training |
| Placebo controlThey will be invited to attend leisure activities organized by a community centre in four different days during the study period. Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park. | Behavioural | Placebo Control |
Primary outcome
change in levels of cancer-related fatigue from baseline at 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
The primary outcomes are levels of cancer-related fatigue at 6 months after starting the intervention among the two groups. The Fatigue Scale - Child will be used to assess the fatigue of subjects who are 7 to 12 years old. For those aged 13 to 18, their fatigue levels will be measured by the Fatigue Scale - Adolescent.
29 secondary outcomes
change in levels of cancer-related fatigue from baseline at 3-month follow-up between intervention and control group
Time frame: 3-month follow-up
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
change in levels of cancer-related fatigue from baseline at 12-month follow-up between intervention and control group
Time frame: 12-months follow-up
levels of cancer-related fatigue at Baseline
Time frame: Baseline
change in physical activity levels from baseline at 6-month follow-up between intervention and control group
Time frame: 6-month follow-up
change in physical activity levels from baseline at 3-month follow-up between intervention and control group
Time frame: 3-month follow-up
change in physical activity levels from baseline at 9-month follow-up between intervention and control group
Time frame: 9-month follow-up
change in physical activity levels from baseline at 12-month follow-up between intervention and control group
Time frame: 12-month follow-up
Physical activity levels activity at Baseline
Time frame: Baseline
Stages of Change at baseline
Time frame: Baseline
change in stages of change from baseline at 3-month follow-up between intervention and control group
Time frame: 3-month follow up
change in stages of change from baseline at 6-month follow-up between intervention and control group
Time frame: 6-month follow up
change in stages of change from baseline at 9-month follow-up between intervention and control group
Time frame: 9-month follow up
change in stages of change from baseline at 12-month follow-up between intervention and control group
Time frame: 12-month follow up
physical activity self-efficacy at baseline
Time frame: baseline
change in physical activity self-efficacy from baseline at 3-month follow-up between intervention and control group
Time frame: 3-month follow up
change in physical activity self-efficacy from baseline at 6-month follow-up between intervention and control group
Time frame: 6-month follow up
change in physical activity self-efficacy from baseline at 9-month follow-up between intervention and control group
Time frame: 9-month follow up
change in physical activity self-efficacy from baseline at 12-month follow-up between intervention and control group
Time frame: 12-month follow up
quality of life at baseline
Time frame: baseline
change in quality of life from baseline at 3-month follow-up between intervention and control group
Time frame: 3-month follow up
change in quality of life from baseline at 6-month follow-up between intervention and control group
Time frame: 6-month follow up
change in quality of life from baseline at 9-month follow-up between intervention and control group
Time frame: 9-month follow up
change in quality of life from baseline at 12-month follow-up between intervention and control group
Time frame: 12-month follow up
muscle strength at baseline
Time frame: baseline
change in muscle strength from baseline at 3-month follow-up between intervention and control group
Time frame: 3-month follow up
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
change in muscle strength from baseline at 12-month follow-up between intervention and control group
Time frame: 12-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 26 Apr 2016.
- 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.
William Ho Cheung Li, PhD principal investigator
The 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 health talk and adventure-based training in people with Malignant Childhood Neoplasm, 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 4 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 26 Apr 2016. 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 6-month follow-up between intervention and control group (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2016.