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

NCT ID: NCT02703935

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-06-30

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.

Detailed 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.

Conditions

Childhood Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

health talk and adventure-based training

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.

Group Type: EXPERIMENTAL

health talk and adventure-based training

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: 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

Interventions

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.

Intervention Type: 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 museums and theme parks and galleries

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Hong Kong

Hong Kong SAR, , China

Countries

China

Other Identifiers

PhD_1

Identifier Type: -

Identifier Source: org_study_id