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

NCT02703935 | Completed

• 1 other identifier: PhD_1
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Cancer

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 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.

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 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.

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 museums and theme parks and galleries

Placebo Control

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong SAR, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 9, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)