Effectiveness of an Adventure-based Training Programme to Reduce Fatigue for Childhood Cancer Survivors

Childhood Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703935
• Other study ID #: PhD_1
• Status: Completed
• Phase: N/A
• First received: March 4, 2016
• Last updated: January 11, 2017
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

The Inclusion Criteria for eligible Hong Kong Chinese childhood cancer survivals are as follows:

• Aged 9 to 16 years;

• Able to speak Cantonese and read Chinese;

• Had completed cancer treatment at least six months previously; and

• Did not engage in regular physical activity for the past 6 months.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Childhood Cancer
• Fatigue

Intervention

Behavioral:
• health talk and adventure-based training
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 Control
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

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6-month follow-up	No
Secondary	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.	3-month follow-up	No
Secondary	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.	9-month follow-up	No
Secondary	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.	12-months follow-up	No
Secondary	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.	Baseline	No
Secondary	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.	6-month follow-up	No
Secondary	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.	3-month follow-up	No
Secondary	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.	9-month follow-up	No
Secondary	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.	12-month follow-up	No
Secondary	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.	Baseline	No
Secondary	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.	Baseline	No
Secondary	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.	3-month follow up	No
Secondary	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.	6-month follow up	No
Secondary	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.	9-month follow up	No
Secondary	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.	12-month follow up	No
Secondary	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.	baseline	No
Secondary	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.	3-month follow up	No
Secondary	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.	6-month follow up	No
Secondary	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.	9-month follow up	No
Secondary	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.	12-month follow up	No
Secondary	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.	baseline	No
Secondary	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.	3-month follow up	No
Secondary	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.	6-month follow up	No
Secondary	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.	9-month follow up	No
Secondary	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.	12-month follow up	No
Secondary	muscle strength at baseline	The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique before randomization.	baseline	No
Secondary	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.	3-month follow up	No
Secondary	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.	6-month follow up	No
Secondary	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.	9-month follow up	No
Secondary	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.	12-month follow up	No