Clinical trial NCT00698113: Parent-Delivered Massage in Paediatric Cancer
Official title: Parent-Delivered Massage in Paediatric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Stress
Pediatric Cancers
Keywords: anxiety
depression
stress
cancer symptoms
pediatric cancer
massage
parent delivered massage
Lead sponsor: Centennial College
Sponsor class: OTHER
Collaborators: name: SickKids Foundation
name: Stollery Children's Hospital
name: Canadian Institute of Natural and Integrative Medicine
First posted: 2008-06-16
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Period of study
Secondary outcomes:
measure: My Story
timeFrame: Week 6
measure: Memorial Symptom Assessment Scale
timeFrame: 0, 6, 12 weeks
measure: Pediatric Inventory for Parents
timeFrame: 0, 6, 12 weeks
measure: Stait-Trait Anxiety Inventory for Adults
timeFrame: 0, 6, 12 weeks
measure: The Center for Epidemiologic Studies Depression (CES-D) Scale
timeFrame: 0, 6, 12 weeks
measure: State-Trait Anxiety Inventory for Children
timeFrame: 0, 6, 12 weeks
measure: Parent Journals
timeFrame: Weekly for 6 weeks
measure: Child Journals
timeFrame: Weekly for 6 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Toronto
country: Canada
facility: Centennial College
state: Ontario
Study officials:
affiliation: Applied Research Centre, Centennial College
name: Trish Dryden, RMT, M.Ed
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Institute of Natural and Integrative Medicine
name: Sabine Moritz, Dipl. Biol., M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Stollery Children's Hospital & University of Alberta
name: Sunita Vohra, MD, FRCPC, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Stollery Children's Hospital
name: Dawn Davies, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Stollery Children's Hospital
name: Adrienne D Witol, Psy.D., C.Psych
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de recherché Hôpital Sainte-Justine CHU Mère-Enfant & McGill University Health Centre
name: Andrea M Laizner, RN, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Le Phare enfants et familles
name: Lyse Lussier
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Janet Kahn, LMT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centennial College
name: Amanda Baskwill, RMT
role: PRINCIPAL_INVESTIGATOR
affiliation: Stollery Children's Hospital
name: Linda Curcher, CCRP
role: PRINCIPAL_INVESTIGATOR
affiliation: Massage Therapist Association of Alberta (MTAA)
name: Elizabeth Barberree, RMT
role: PRINCIPAL_INVESTIGATOR
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