Parent-Delivered Massage in Paediatric Cancer

Not Applicable

• Conditions: Anxiety; Depression; Stress; Pediatric Cancers
• Interventions: Procedure: Massage; Other: Journaling

• Registration Number: NCT00698113
• Lead Sponsor: Centennial College

Brief Summary

The purpose of this study is to determine how parents of children with cancer rate a parent-delivered massage therapy educational program for usability and satisfaction, and if massage therapy, provided by parents to their child with cancer, reduce symptoms of anxiety and depression in the child, and parenting stress in the parent.

Detailed Description

In Canadian children aged 0-19, the number of new cancer cases from 1997-2001 was on average 1,285 children per year for a total of 6,427 children over a five year period. Individual and family responses to a child's or adolescent's cancer diagnosis and treatment include psychological, sociocultural and biological dimensions. Parents of children with cancer can experience severe emotional distress including anxiety and depression. Parents require support and skills to reduce their own anxiety and distress and to help alleviate suffering in their children.

This is a two-phase research project: phase I: development of a standardized educational intervention on video/DVD to teach parents how to massage their child with cancer; phase II: test the feasibility of the developed intervention with children with cancer and their parents. A total of 24 parents and their children with cancer who are under the care of the paediatric oncology units at the Stollery Children's Hospital (Edmonton) will be recruited for the study.

It is hypothesized that this research on an educational program in parent-delivered massage therapy will directly improve the lives of children with cancer and their parents.

Study Timeline

• Study Start: 2007-04
• Status Verified: 2008-06
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-16
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-17
• Last Update Posted: 2009-06-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Children aged 6 to 18 years
• Children with a life expectancy of at least 12 weeks
• Children who are currently receiving active cancer care

Exclusion Criteria

• Children under the age of 6
• Children with a life expectancy of less than 12 weeks
• Children not currently receiving active cancer care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Massage	This group receives the massage intervention for a period of six weeks. Children and parents are asked to journal weekly for the six week period.
1	Journaling	This group receives the massage intervention for a period of six weeks. Children and parents are asked to journal weekly for the six week period.
2	Journaling	The control group does not receive any massage intervention during the initial six weeks of the study. The children are asked to journal during this six week period.

Primary Outcome Measures

Name	Time	Method
To test the feasibility of the educational intervention in parent-delivered massage for children undergoing treatment for cancer at a paediatric oncology centre, to guide sample size estimation for a future randomized trial.	Period of study

Secondary Outcome Measures

Name	Time	Method
My Story	Week 6
Memorial Symptom Assessment Scale	0, 6, 12 weeks
Pediatric Inventory for Parents	0, 6, 12 weeks
Stait-Trait Anxiety Inventory for Adults	0, 6, 12 weeks
The Center for Epidemiologic Studies Depression (CES-D) Scale	0, 6, 12 weeks
State-Trait Anxiety Inventory for Children	0, 6, 12 weeks
Parent Journals	Weekly for 6 weeks
Child Journals	Weekly for 6 weeks

Trial Locations

Locations (2)

Centennial College; 🇨🇦 Toronto, Ontario, Canada

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada