Childhood CancerNCT02703935
Effectiveness of an Adventure-based Training Programme to Reduce Fatigue for Childhood Cancer Survivors
A study testing health talk and adventure-based training in people with Childhood Cancer, run by The University of Hong Kong at 1 site in China.
Trial summary
Background: Cancer-related fatigue is the most common concern reported by Childhood cancer survivors. Empirical evidence is needed to find out an appropriate strategy for ameliorating its impact. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Childhood Cancer
- 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
- 222 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jun 2016
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- The investigators will exclude childhood cancer survivors with evidence of recurrence or second malignancies, and 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 Adventure-based Training Programme in Promoting Regular Physical Activity, Reducing Fatigue and Enhancing Quality of Life Among Hong Kong Chinese Childhood Cancer Survivors
Background: Cancer-related fatigue is the most common concern reported by Childhood cancer survivors. Empirical evidence is needed to find out an appropriate strategy for ameliorating its impact.
Purposes: To examine the effectiveness of an adventure-based training programme in promoting regular physical activity, reducing fatigue and enhancing 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 has been conducted. Recruitment of subjects has been carried out in an outpatient clinic, and through the Children's Cancer Foundation and Sunshine Group, which are non-profit voluntary organizations with the aim to provide education and supportive services to parents of Hong Kong Chinese childhood cancer survivors.
Intervention: Participants in the experimental group have joined a four-day adventure-based training programme, which contains education talks, a workshop and adventure-based training activities. Those in the placebo control group has received an amount of time and attention (leisure activities organized by a community centre) that mimick that received by the experimental group.
Read the detailed description
The aim of this study is to examine the effectiveness of an adventure-based training programme in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer survivors.
Intervention
Experimental group
Besides receiving medical follow-up, participants have joined a four-day adventure-based training 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 is tailor-made for participants in which they do not engage in regular physical activity.
Placebo control group
Participants will receive medical follow-up according to the schedule of the oncology units. Besides, participants will receive an amount of time and attention that mimic 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 include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museums and theme parks and galleries.
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 has been taken. An advisory committee has been set up with the purpose to develop an appropriate programme for Hong Kong Chinese childhood cancer survivors. The committee includes an associate professor, a lecturer and a research student 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 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 has been sent to a professional adventure-based training centre for content validation. The programme has been 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 has been implemented in small group with maximum 12 participants in one group. Health education talks and workshop have been implemented in between adventure-based training activities in day camp centre, conducted by healthcare professionals working in a local university. Adventure-based training activities have been 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 join 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
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 Group and Children's Cancer Foundation. 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 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) 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
- Childhood Cancer
- Being tested
- health talk and adventure-based training, 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.
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 an associate professor, an assistant professor and a research student at a local university, a pediatric oncologist and oncology nurse 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 survivors.
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 museums and theme parks and galleries
| Study group | Role | What they receive |
|---|---|---|
| health talk and adventure-based training | Experimental | Participate will join a four-day 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 12 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 3 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 posted9 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703935
- Sponsor's protocol ID
- PhD_1
- Status last verified
- Jan 2017
- First submitted
- 4 Mar 2016
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Adventure-based Training Programme in Promoting Regular Physical Activity, Reducing Fatigue and Enhancing Quality of Life Among Hong Kong Chinese Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT02703935
- Acronym / sponsor ID
- PhD_1
- Conditions
- Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Mar 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: Cancer-related fatigue is the most common concern reported by Childhood cancer survivors. Empirical evidence is needed to find out an appropriate strategy for ameliorating its impact.
Purposes: To examine the effectiveness of an adventure-based training programme in promoting regular physical activity, reducing fatigue and enhancing 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 has been conducted. Recruitment of subjects has been carried out in an outpatient clinic, and through the Children's Cancer Foundation and Sunshine Group, which are non-profit voluntary organizations with the aim to provide education and supportive services to parents of Hong Kong Chinese childhood cancer survivors.
Intervention: Participants in the experimental group have joined a four-day adventure-based training programme, which contains education talks, a workshop and adventure-based training activities. Those in the placebo control group has received an amount of time and attention (leisure activities organized by a community centre) that mimick that received by the experimental group.
Detailed description
The aim of this study is to examine the effectiveness of an adventure-based training programme in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer survivors.
Intervention
Experimental group
Besides receiving medical follow-up, participants have joined a four-day adventure-based training 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 is tailor-made for participants in which they do not engage in regular physical activity.
Placebo control group
Participants will receive medical follow-up according to the schedule of the oncology units. Besides, participants will receive an amount of time and attention that mimic 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 include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museums and theme parks and galleries.
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 has been taken. An advisory committee has been set up with the purpose to develop an appropriate programme for Hong Kong Chinese childhood cancer survivors. The committee includes an associate professor, a lecturer and a research student 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 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 has been sent to a professional adventure-based training centre for content validation. The programme has been 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 has been implemented in small group with maximum 12 participants in one group. Health education talks and workshop have been implemented in between adventure-based training activities in day camp centre, conducted by healthcare professionals working in a local university. Adventure-based training activities have been 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 join 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
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 Group and Children's Cancer Foundation. 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 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) 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
- Single blind (outcomes assessor)
- 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 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 12 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
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- The investigators will exclude childhood cancer survivors with evidence of recurrence or second malignancies, and 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 an associate professor, an assistant professor and a research student at a local university, a pediatric oncologist and oncology nurse 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 survivors. | 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 museums and theme parks and galleries | 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 13 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Childhood Cancer, 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 0 inclusion and 1 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 13 Jan 2017. 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 13 Jan 2017.