Effectiveness of an Integrated Programme in Promoting the Regular Physical Activity Among Childhood Cancer Survivors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01803672
First received: February 26, 2013
Last updated: April 25, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention
Malignant Childhood Neoplasm
Behavioral: health talk and adventure-based training
Behavioral: Placebo control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • levels of cancer-related fatigue at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • change in physical activity levels from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    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.

  • change in physical activity levels from baseline at 3-month follow-up between intervention and control group [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
    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.

  • change in physical activity levels from baseline at 9-month follow-up between intervention and control group [ Time Frame: 9-month follow-up ] [ Designated as safety issue: No ]
    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.

  • change in physical activity levels from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
    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.

  • Physical activity levels activity at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Stages of Change at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • change in stages of change from baseline at 3-month follow-up between intervention and control group [ Time Frame: 3-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in stages of change from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in stages of change from baseline at 9-month follow-up between intervention and control group [ Time Frame: 9-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in stages of change from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow up ] [ Designated as safety issue: No ]
    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.

  • physical activity self-efficacy at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • change in physical activity self-efficacy from baseline at 3-month follow-up between intervention and control group [ Time Frame: 3-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in physical activity self-efficacy from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in physical activity self-efficacy from baseline at 9-month follow-up between intervention and control group [ Time Frame: 9-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in physical activity self-efficacy from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow up ] [ Designated as safety issue: No ]
    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.

  • quality of life at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • change in quality of life from baseline at 3-month follow-up between intervention and control group [ Time Frame: 3-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in quality of life from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in quality of life from baseline at 9-month follow-up between intervention and control group [ Time Frame: 9-month follow up ] [ Designated as safety issue: No ]
    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.

  • change in quality of life from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow up ] [ Designated as safety issue: No ]
    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.

  • muscle strength at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    the isokinetic strength of muscles will be measured by a dynamometer using a break and make technique before randomization.

  • change in muscle strength from baseline at 3-month follow-up between intervention and control group [ Time Frame: 3-month follow up ] [ Designated as safety issue: No ]
    The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 3 months after starting the intervention.

  • change in muscle strength from baseline at 6-month follow-up between intervention and control group [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 6 months after starting the intervention.

  • change in muscle strength from baseline at 9-month follow-up between intervention and control group [ Time Frame: 9-month follow up ] [ Designated as safety issue: No ]
    The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 9 months after starting the intervention.

  • change in muscle strength from baseline at 12-month follow-up between intervention and control group [ Time Frame: 12-month follow up ] [ Designated as safety issue: No ]
    The isokinetic strength of muscles will be measured by a dynamometer using a break and make technique 12 months after starting the intervention.


Enrollment: 71
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: health talk and adventure-based training
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.
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 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 Comparator: Placebo Control
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.
Behavioral: 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 museum and theme park.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • childhood cancer survivors with evidence of recurrence or second malignancies
  • those with physical impairment or cognitive and learning problems identified from their medical records
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803672

Locations
China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: William Ho Cheung Li, PhD The School of Nursing, The University of Hong Kong
  More Information

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01803672     History of Changes
Other Study ID Numbers: 102009189 
Study First Received: February 26, 2013
Last Updated: April 25, 2016
Health Authority: Hong Kong: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The University of Hong Kong:
Adventure-Based training
Health education
childhood cancer
physical activity

ClinicalTrials.gov processed this record on July 28, 2016