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

NCT01803672 | Completed DMC

• 1 other identifier: 102009189
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Background.There is some evidence that engaging in regular moderate-intensity physical activity may help ameliorate cancer-related fatigue experienced by childhood cancer survivors, which eventually improve their quality of life. 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.

Conditions

Malignant Childhood Neoplasm

Keywords

Adventure-Based training; Health education; childhood cancer; physical activity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (29)

• change in levels of cancer-related fatigue from baseline at 3-month follow-up between intervention and control group

  3-month follow-up

• change in levels of cancer-related fatigue from baseline at 9-month follow-up between intervention and control group

  9-month follow-up

• change in levels of cancer-related fatigue from baseline at 12-month follow-up between intervention and control group

  12-months follow-up

• levels of cancer-related fatigue at Baseline

  Baseline

• change in physical activity levels from baseline at 6-month follow-up between intervention and control group

  6-month follow-up

Study Arms (2)

health talk and adventure-based training

EXPERIMENTAL

Participate will join a four-day integrated health education and adventure-based training programme, which contains education talks, workshop and adventure-based training activities. The programme will be implemented on four different days within six months in a day camp training centre. The integrated programme will be implemented in small group with maximum 15 participants in one group. Health education talks and workshop will be implemented in between adventure-based training activities in day camp centre, which will be conducted by healthcare professionals working in a local university.

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.

Behavioral: Placebo control

Interventions

health talk and adventure-based training BEHAVIORAL

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.

health talk and adventure-based training

Placebo control BEHAVIORAL

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.

Placebo Control

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• childhood cancer survivors with evidence of recurrence or second malignancies
• those with physical impairment or cognitive and learning problems identified from their medical records

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Neoplasms; Health Education; Motor Activity

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• William Ho Cheung Li, PhD

  The School of Nursing, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)