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: February 28, 2013
Last verified: February 2013
  Purpose

Background.There is also some evidence that engaging in regular moderate-intensity physical activity may help ameliorate some of the treatment-related adverse effects 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 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

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 from baseline Physical activity levels activity at 3 months [ Time Frame: 3 months after the intervention ] [ Designated as safety issue: No ]
    The physical activity levels of participants were 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 were asked to respond to the Chinese version of the CUHK-PARCY at 3 months after the intervention.


Secondary Outcome Measures:
  • Stages of Change at baseline [ Time Frame: Baseline (just after randomization) ] [ Designated as safety issue: No ]
    The current stages of exercising patterns for participants were evaluated by an adapted version of PASCQ.It is a binary type (yes/no) questionnaire, and contains four items.Participants answer each question about their physical activity practices with a 'yes' or a 'no', and according to these responses they are classified into five different stages by means of a scoring algorithm.Participant were asked to respond to the Chinese version of the PASCQ before the randomization.

  • Change from Baseline Stages of Change at 3 months [ Time Frame: 3 months after the intervention ] [ Designated as safety issue: No ]
    The current stages of exercising patterns for participants were evaluated by an adapted version of PASCQ.It is a binary type (yes/no) questionnaire, and contains four items.Participants answer each question about their physical activity practices with a 'yes' or a 'no', and according to these responses they are classified into five different stages by means of a scoring algorithm.Participant were asked to respond to the Chinese version of the PASCQ at 3 months after the intervention.

  • Change from Baseline Stages of Change at 6 months [ Time Frame: 6 months after the intervention ] [ Designated as safety issue: No ]
    The current stages of exercising patterns for participants were evaluated by an adapted version of PASCQ.It is a binary type (yes/no) questionnaire, and contains four items.Participants answer each question about their physical activity practices with a 'yes' or a 'no', and according to these responses they are classified into five different stages by means of a scoring algorithm.Participant were asked to respond to the Chinese version of the PASCQ at 6 months after the intervention.

  • Change from Baseline Stages of Change at 9 months [ Time Frame: 9 months after the intervention ] [ Designated as safety issue: No ]
    The current stages of exercising patterns for participants were evaluated by an adapted version of PASCQ.It is a binary type (yes/no) questionnaire, and contains four items.Participants answer each question about their physical activity practices with a 'yes' or a 'no', and according to these responses they are classified into five different stages by means of a scoring algorithm.Participant were asked to respond to the Chinese version of the PASCQ at 9 months after the intervention.

  • Physical activity levels activity at Baseline [ Time Frame: Baseline (just after randomization) ] [ Designated as safety issue: No ]
    The physical activity levels of participants were 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 were asked to respond to the Chinese version of the CUHK-PARCY before randomization.

  • Change from baseline Physical activity levels activity at 6 months [ Time Frame: 6 months after the intervention ] [ Designated as safety issue: No ]
    The physical activity levels of participants were 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 were asked to respond to the Chinese version of the CUHK-PARCY at 6 months after the intervention.

  • Change from baseline Physical activity levels activity at 9 months [ Time Frame: 9 months after the intervention ] [ Designated as safety issue: No ]
    The physical activity levels of participants were 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 were asked to respond to the Chinese version of the CUHK-PARCY at 9 months after the intervention.

  • Physical Activity Self-Efficacy at Baseline [ Time Frame: Baseline (just after randomization) ] [ Designated as safety issue: No ]
    The PA-SE was used to measure the children's self-confidence in their ability to participate in various age-appropriate physical activities. The PA-SE includes five items in which children are asked if they are 'not sure', 'a little sure'or 'very sure' that they can do such things as 'keep up a steady pace without stopping for 15-20 min'. Higher scores indicate higher self-efficacy. Participants were asked to respond to the Chinese version of the PA-SE after the randomization.

  • Change from Baseline Physical Activity Self-Efficacy at 3 months [ Time Frame: 3 months after intervnetion ] [ Designated as safety issue: No ]
    The PA-SE was used to measure the children's self-confidence in their ability to participate in various age-appropriate physical activities. The PA-SE includes five items in which children are asked if they are 'not sure', 'a little sure'or 'very sure' that they can do such things as 'keep up a steady pace without stopping for 15-20 min'. Higher scores indicate higher self-efficacy. Participants were asked to respond to the Chinese version of the PA-SE after 3 months of intervention.

  • Change from Baseline Physical Activity Self-Efficacy at 6 months [ Time Frame: 6 months after the intervention ] [ Designated as safety issue: No ]
    The PA-SE was used to measure the children's self-confidence in their ability to participate in various age-appropriate physical activities. The PA-SE includes five items in which children are asked if they are 'not sure', 'a little sure'or 'very sure' that they can do such things as 'keep up a steady pace without stopping for 15-20 min'. Higher scores indicate higher self-efficacy. Participants were asked to respond to the Chinese version of the PA-SE after 6 months of intervention.

  • Change from Baseline Physical Activity Self-Efficacy at 9 months [ Time Frame: 9 months after the intervention ] [ Designated as safety issue: No ]
    The PA-SE was used to measure the children's self-confidence in their ability to participate in various age-appropriate physical activities. The PA-SE includes five items in which children are asked if they are 'not sure', 'a little sure'or 'very sure' that they can do such things as 'keep up a steady pace without stopping for 15-20 min'. Higher scores indicate higher self-efficacy. Participants were asked to respond to the Chinese version of the PA-SE after 9 months of intervention.

  • Quality of Life at baseline [ Time Frame: Baseline (just after randomization) ] [ Designated as safety issue: No ]
    The PedsQL was 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 were 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 were asked to respond to the Chinese version of the PedsQL before the randomization.

  • Change from Baseline Quality of Life at 3 months [ Time Frame: 3 months after intervnetion ] [ Designated as safety issue: No ]
    The PedsQL was 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 were 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. Participants were asked to respond to the Chinese version of the PedsQL after 3 months of intervention.

  • Change from Baseline Quality of Life at 6 months [ Time Frame: 6 months after intervnetion ] [ Designated as safety issue: No ]
    The PedsQL was 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 were 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. Participants were asked to respond to the Chinese version of the PedsQL after 6 months of intervention.

  • Change from Baseline Quality of Life at 9 months [ Time Frame: 9 months after intervnetion ] [ Designated as safety issue: No ]
    The PedsQL was 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 were 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. Participants were asked to respond to the Chinese version of the PedsQL after 9 months of 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
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 9 and 16 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

No publications provided

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: February 28, 2013
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014