Clinical trial NCT02754973: Integrated Experiential Training Program With Coaching by Nursing Students in Childhood Cancer Patients
Official title: Effectiveness of an Integrated Experiential Training Program With Coaching by Nursing Students in Promoting Regular Physical Activity and Reducing Fatigue Among Childhood Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Neoplasms
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Despite the evidence that regular physical activity can have beneficial effects on the physical and psychological well-being of cancer patients, a review of the literature reveals that a majority of young cancer patients fail to attain the same levels of physical activity that they had before contracting the disease. There is scientific evidence that physical inactivity induces muscle catabolism and atrophy and cardiovascular diseases, which may lead to a further increase in fatigue and a decrease in the functional capacity of cancer patients. Empirical evidence is needed to explore an appropriate strategy for promoting physical activity in such patients.

Purposes: To examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.

Design and Subjects: A randomised controlled trial (RCT), two-group pre-test and repeated post-test, within and between subjects design will be conducted. Recruitment of subjects will be carried out in a paediatric oncology ward of a Hong Kong acute care hospital.

Intervention: Participants in the experimental group will join an integrated experiential training program with coaching by nursing students, which contains 28 home visits by a designated nursing student as a coach for a 6-month period. Those in the placebo control group will receive an amount of time and attention (home visits by research assistants) that mimics that received by the experimental group.

Detailed description: The aim of this study is to examine the effectiveness of an integrated experiential training program with coaching by nursing students in promoting regular physical activity, reducing fatigue and enhancing quality of life among Hong Kong Chinese childhood cancer patients.

Intervention

Experimental group

During hospitalization for cancer treatment, besides receiving usual care, a registered nurse will deliver participants a health education talk. Participants will then be taught and encouraged to practice some simple stretching and relaxing exercises. After discharged from the hospital, participants in the experimental group are scheduled to take part in an integrated experiential training program with coaching by nursing students. Each participant is allocated to a nursing student who was voluntarily trained as coaches for the program. The intervention is implemented to each participant by the designated coach during 28 home visits throughout a 6-month period (24 weeks) and each visit lasts for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach pays a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. During the individual coaching sessions with the young people, the coaches will teach and demonstrate physical activities in 4 levels to the participants according to participants' ability.

Placebo control group

Since participants in both groups are hospitalized in the same unit, to avoid contamination, participants in the placebo control group will receive the same intervention as those participants in the experimental group during their hospitalization. When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The activities during the home visits over a six-month period include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.

To ensure the dosage of intervention delivered in terms of the amount, frequency, duration, and breadth would be adequate to assess physical activity levels, physical activity self-efficacy, cancer-related fatigue, depression, muscle strength, and quality of life, a research committee is crucial to assess the dosage of the intervention and to train the volunteer nursing students as coaches for the intervention. In particular, the safety and appropriateness of the intervention content were reviewed carefully by the committee before commencement. The members in the committee consist of an associate professor, an assistant professor and a research student from a local university who are equipped with extensive experience in conducting different research and particularly, psychosocial interventions for children with cancer. The committee also includes a professor in paediatric oncology and a specialist nurse with substantial experience in delivering care to children undergoing cancer treatment, and an assistant professor who is an expert specialising in sports and recreation management.

Data Collection Methods

Approval for the study was obtained from the hospital ethics committees. To identify potential subjects, the research student approach to eligible children and their parents after screening the medical records in a paediatric oncology ward of a public acute care hospital in Hong Kong. After explaining the study details, including its purpose, procedures and potential harms and benefits, parents allowing their children to take part are required to sign a consent form. In addition, the children who are going to participate are invited to write down their names on a specially designed child assent form and told that their participation is voluntary.

Data collection for the outcome variables is conducted at the time of the subject recruitment (T1), and six (T2), and nine (T3) months after the start of the intervention, except that physical activity levels of childhood cancer patients are collected at the time of the subject recruitment (T1), and nine (T2) months after the start of the intervention. Before randomisation, participants are required to complete the hand grip strength test with the hand-held dynamometers (HHD) and fill in a set of questionnaires including CUHK-PARCY, the Chinese versions of PA-SE, fatigue scale, CES-DC, and PedsQL cancer module. Semi-structured interviews will also be carried out.

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) and post-hoc analysis using the Tukey procedure will be used to determine whether the integrated experiential training program with coaching by nursing students was effective in reducing fatigue, increasing childhood cancer patients' levels of physical activity, self-efficacy and muscle strength, decreasing depressive symptoms and enhancing their quality of life. Descriptive phenomenology will be employed during the process of qualitative data analysis.

Eligibility criteria: Inclusion Criteria:

* aged between 9 to 18
* diagnosed with cancer at some time in the previous month and currently undergoing active treatments
* able to speak Cantonese and read Chinese

Exclusion Criteria:

* evidence of recurrence or second malignancies
* physical impairment or cognitive or learning problems identified from their medical records

Primary outcomes:
measure: Change in levels of cancer-related fatigue from baseline at 9 month follow-up between intervention and control group
timeFrame: 9 month follow-up
Secondary outcomes:
measure: Levels of cancer-related fatigue at baseline
timeFrame: baseline
measure: Change in cancer-related fatigue from baseline at 6 month follow-up between intervention and control group
timeFrame: 6 month follow-up
measure: Levels of physical activity at baseline
timeFrame: baseline
measure: Levels of physical activity self-efficacy at baseline
timeFrame: baseline
measure: Change in levels of physical activity self-efficacy from baseline at 6 month follow-up
timeFrame: 6 month follow-up
measure: Change in levels of physical activity self-efficacy from baseline at 9 month follow-up
timeFrame: 9 month follow-up
measure: Depressive symptoms at baseline
timeFrame: baseline
measure: Change in depressive symptoms from baseline at 6 month follow-up
timeFrame: 6 month follow-up
measure: Change in depressive symptoms from baseline at 9 month follow-up
timeFrame: 9 month follow-up
measure: Muscle strength at baseline
timeFrame: basline
measure: Change in muscle strength from baseline at 6 month follow-up between intervention and control group
timeFrame: 6 month follow-up
measure: Change in muscle strength from baseline at 9 month follow-up between intervention and control group
timeFrame: 9 month follow-up
measure: Levels of quality of life at baseline
timeFrame: baseline
measure: Change in levels of quality of life from baseline at 6 month follow-up between intervention and control group
timeFrame: 6 month follow-up
measure: Change in levels of quality of life from baseline at 9 month follow-up between intervention and control group
timeFrame: 9 month follow-up
measure: Change in levels of physical activity from baseline at 9 month follow-up between intervention and control group
timeFrame: 9 month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ho Cheung William Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam KKW, Li WHC, Chung OK, Ho KY, Chiu SY, Lam HS, Chan GCF. An integrated experiential training programme with coaching to promote physical activity, and reduce fatigue among children with cancer: A randomised controlled trial. Patient Educ Couns. 2018 Nov;101(11):1947-1956. doi: 10.1016/j.pec.2018.07.008. Epub 2018 Jul 7.