Parent-Delivered Massage in Paediatric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parent-Delivered Massage in Paediatric Cancer

Conditions
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Anxiety, Depression, Stress, Pediatric Cancers

Intervention / Treatment
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* Procedure: Massage
* Other: Journaling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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. | Procedure: Massage<br>* Children will receive a 10-15 minute massage seated (clothed), or in bed (clothed or unclothed) each day using the following protocol: stroking, effleurage, petrissage, muscle squeezing, effleurage, stroking. Massaged areas can include the back, arms and legs. Parents will receive a one hour educational session with a Massage Therapist, a DVD, and written materials that all illustrate the required protocol.<br>* Other names: massage therapy;Other: Journaling<br>* Children will complete weekly journals about their feelings. These journals will either be drawn or written based on the preference of the child. Parents will complete a weekly journal outlining the number of massages given to their child, barriers that prevented massage, and their experience of giving the massage.<br>* Other names: reflection;|
| No Intervention: 2<br>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. | Other: Journaling<br>* Children will complete weekly journals about their feelings. These journals will either be drawn or written based on the preference of the child. Parents will complete a weekly journal outlining the number of massages given to their child, barriers that prevented massage, and their experience of giving the massage.<br>* Other names: reflection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, depression, stress, cancer symptoms, pediatric cancer, massage, parent delivered massage