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Parent-Delivered Massage in Paediatric Cancer
This study is currently recruiting participants.
Study NCT00698113   Information provided by Centennial College
First Received: June 12, 2008   Last Updated: November 25, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 12, 2008
November 25, 2008
April 2007
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. [ Time Frame: Period of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00698113 on ClinicalTrials.gov Archive Site
  • My Story [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Memorial Symptom Assessment Scale [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
  • Pediatric Inventory for Parents [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
  • Stait-Trait Anxiety Inventory for Adults [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
  • The Center for Epidemiologic Studies Depression (CES-D) Scale [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory for Children [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
  • Parent Journals [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
  • Child Journals [ Time Frame: Weekly for 6 weeks ] [ Designated as safety issue: No ]
  • My Story [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Memorial Symptom Assessment Scale [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
  • Pediatric Inventory for Parents [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
 
Parent-Delivered Massage in Paediatric Cancer
Parent-Delivered Massage in Paediatric Cancer

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.

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.

 
Interventional
Supportive Care, Randomized, Open Label, Crossover Assignment, Efficacy Study
  • Anxiety
  • Depression
  • Stress
  • Pediatric Cancers
  • Procedure: Massage
  • Other: Journaling
  • Active Comparator: 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.
  • No Intervention: 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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
24
June 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact: Trish Dryden, RMT, M.Ed 416-289-5000 ext 8056 tdryden@centennialcollege.ca
Contact: Stacey Neilson, BA (Hons), RMT 416-289-5999 ext 8397 sneilson@rogers.com
Canada
 
 
NCT00698113
Trish Dryden, RMT, M.Ed, Director, Applied Research Centre, Centennial College
CAM 07-323R
Centennial College
  • SickKids Foundation
  • Stollery Children's Hospital
  • Canadian Institute of Natural and Integrative Medicine
Principal Investigator: Trish Dryden, RMT, M.Ed Applied Research Centre, Centennial College
Principal Investigator: Sabine Moritz, Dipl. Biol., M.Sc Canadian Institute of Natural and Integrative Medicine
Principal Investigator: Sunita Vohra, MD, FRCPC, M.Sc Stollery Children's Hospital & University of Alberta
Principal Investigator: Dawn Davies, MD, FRCPC Stollery Children's Hospital
Principal Investigator: Adrienne D Witol, Psy.D., C.Psych Stollery Children's Hospital
Principal Investigator: Andrea M Laizner, RN, Ph.D Centre de recherché Hôpital Sainte-Justine CHU Mère-Enfant & McGill University Health Centre
Principal Investigator: Lyse Lussier Le Phare enfants et familles
Principal Investigator: Janet Kahn, LMT, Ph.D. University of Vermont
Principal Investigator: Amanda Baskwill, RMT Centennial College
Principal Investigator: Linda Curcher, CCRP Stollery Children's Hospital
Principal Investigator: Elizabeth Barberree, RMT Massage Therapist Association of Alberta (MTAA)
Centennial College
June 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.