Parent-Delivered Massage in Paediatric Cancer

June 17, 2009 updated by: Centennial College
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Stollery Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linda Churcher, CCRP
    • Ontario
      • Toronto, Ontario, Canada, M1K 5E9
        • Active, not recruiting
        • Centennial College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • 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 Names:
  • reflection
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.
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 Names:
  • reflection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Period of study
Period of study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centennial College

Collaborators

Stollery Children's Hospital
SickKids Foundation
Canadian Institute of Natural and Integrative Medicine

Investigators

  • 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ANTICIPATED)

April 1, 2009

Study Completion (ANTICIPATED)

June 1, 2009

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (ESTIMATE)

June 16, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2009

Last Update Submitted That Met QC Criteria

June 17, 2009

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CENT-SK-CAM07-323R
  • CAM 07-323R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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