Integrated Experiential Training Program With Coaching by Nursing Students in Childhood Cancer Patients

NCT02754973 | Completed DMC

• 1 other identifier: UW15-219
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Child; Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  The primary outcomes are levels of cancer-related fatigue at 9 months after starting the intervention. The Chinese version of Fatigue Scale will be used to assess the fatigue of subjects.

  9 month follow-up

Secondary Outcomes (16)

• Levels of cancer-related fatigue at baseline

  baseline

• Change in cancer-related fatigue from baseline at 6 month follow-up between intervention and control group

  6 month follow-up

• Levels of physical activity at baseline

  baseline

• Levels of physical activity self-efficacy at baseline

  baseline

• Change in levels of physical activity self-efficacy from baseline at 6 month follow-up

  6 month follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

During hospitalization for cancer treatment, besides receiving usual care, participants in the experimental group will first receive a health education talk Participants will then be taught and encouraged to practice with some stretching and relaxing exercises during their hospitalization. After hospitalization, participants will receive an integrated experiential training program with coaching by nursing students through home visits.

Behavioral: an integrated experiential training program with coaching

Placebo Control group

PLACEBO COMPARATOR

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.

Behavioral: Placebo Control

Interventions

an integrated experiential training program with coaching BEHAVIORAL

The intervention will be implemented to each participant by a designated coach who is a trained nursing student during 28 home visits throughout a 6-month period (24 weeks) and each visit will last 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 will pay a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. 4 levels of physical activity will be taught to the participants gradually according to their ability.

Experimental group

Placebo Control BEHAVIORAL

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 placebo activities during the home visits may 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.

Placebo Control group

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• evidence of recurrence or second malignancies
• physical impairment or cognitive or 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, China

Location

Related Publications (1)

• 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.

  PMID: 30007765 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ho Cheung William Li

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

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: April 19, 2016
• First Posted: April 28, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)