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Parent-Delivered Massage in Paediatric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698113
Recruitment Status : Unknown
Verified June 2008 by Centennial College.
Recruitment status was:  Recruiting
First Posted : June 16, 2008
Last Update Posted : June 19, 2009
Sponsor:
Collaborators:
SickKids Foundation
Stollery Children's Hospital
Canadian Institute of Natural and Integrative Medicine
Information provided by:
Centennial College

Tracking Information
First Submitted Date  ICMJE June 12, 2008
First Posted Date  ICMJE June 16, 2008
Last Update Posted Date June 19, 2009
Study Start Date  ICMJE April 2007
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2008)
  • Stait-Trait Anxiety Inventory for Adults [ Time Frame: 0, 6, 12 weeks ]
  • The Center for Epidemiologic Studies Depression (CES-D) Scale [ Time Frame: 0, 6, 12 weeks ]
  • State-Trait Anxiety Inventory for Children [ Time Frame: 0, 6, 12 weeks ]
  • Parent Journals [ Time Frame: Weekly for 6 weeks ]
  • Child Journals [ Time Frame: Weekly for 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
  • My Story [ Time Frame: Week 6 ]
  • Memorial Symptom Assessment Scale [ Time Frame: 0, 6, 12 weeks ]
  • Pediatric Inventory for Parents [ Time Frame: 0, 6, 12 weeks ]
  • Stait-Trait Anxiety Inventory for Adults [ Time Frame: 0, 6, 12 weeks ]
  • The Center for Epidemiologic Studies Depression (CES-D) Scale [ Time Frame: 0, 6, 12 weeks ]
  • State-Trait Anxiety Inventory for Children [ Time Frame: 0, 6, 12 weeks ]
  • Parent Journals [ Time Frame: Weekly for 6 weeks ]
  • Child Journals [ Time Frame: Weekly for 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2008)
  • My Story [ Time Frame: Week 6 ]
  • Memorial Symptom Assessment Scale [ Time Frame: 0, 6, 12 weeks ]
  • Pediatric Inventory for Parents [ Time Frame: 0, 6, 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parent-Delivered Massage in Paediatric Cancer
Official Title  ICMJE Parent-Delivered Massage in Paediatric Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anxiety
  • Depression
  • Stress
  • Pediatric Cancers
Intervention  ICMJE
  • Procedure: Massage

    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.

    Other Name: massage therapy
  • Other: Journaling
    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.
    Other Name: reflection
Study Arms  ICMJE
  • Active Comparator: 1
    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.
    Interventions:
    • Procedure: Massage
    • Other: Journaling
  • No Intervention: 2
    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.
    Intervention: Other: Journaling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 12, 2008)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2009
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698113
Other Study ID Numbers  ICMJE CENT-SK-CAM07-323R
CAM 07-323R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trish Dryden, RMT, M.Ed, Director, Applied Research Centre, Centennial College
Study Sponsor  ICMJE Centennial College
Collaborators  ICMJE
  • SickKids Foundation
  • Stollery Children's Hospital
  • Canadian Institute of Natural and Integrative Medicine
Investigators  ICMJE
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)
PRS Account Centennial College
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP