Parent-Delivered Massage in Paediatric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Centennial College.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
SickKids Foundation
Stollery Children's Hospital
Canadian Institute of Natural and Integrative Medicine
Information provided by:
Centennial College
ClinicalTrials.gov Identifier:
NCT00698113
First received: June 12, 2008
Last updated: June 17, 2009
Last verified: June 2008
  Purpose

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.


Condition Intervention
Anxiety
Depression
Stress
Pediatric Cancers
Procedure: Massage
Other: Journaling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Parent-Delivered Massage in Paediatric Cancer

Resource links provided by NLM:


Further study details as provided by Centennial College:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: April 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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 Name: reflection

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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698113

Contacts
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

Locations
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Linda Churcher, CCRP    780-407-8790    lindachurcher@cha.ab.ca   
Contact: Ronda Blasco    780-407-2056    Ronda.Blasco@capitalhealth.ca   
Principal Investigator: Linda Churcher, CCRP         
Canada, Ontario
Centennial College Active, not recruiting
Toronto, Ontario, Canada, M1K 5E9
Sponsors and Collaborators
Centennial College
SickKids Foundation
Stollery Children's Hospital
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)
  More Information

Additional Information:
Publications:
Field T, Cullen C, Diego M, Hernandez-Reif M, Sprinz P, Beebe K, Kissel B, Bango-Sanchez V. Leukemia immune changes following massage therapy. Journal of Bodywork & Movement Therapies 5(4): 271-274, 2001.
Laizner AM, Lussier L. Massage provides comfort to children with cancer: the child's perspective. Journal of Complementary & Integrative Medicine 2(1): 34, 2005
Laizner AM, Lussier L. Massage program relives suffering for parents while provides comfort for children. Journal of Complementary & Integrative Medicine 2(1): 35, 2005.
Phipps S, Dunavant M, Gray E, Rai SN. Massage therapy in children undergoing hematopoietic stem cell transplant: results of a pilot trial. Journal of Cancer Integrated Medicine 3: 62-70, 2005.
Curties D. Massage therapy and cancer. Moncton, NB: Curties-Overzet Publications, 1988.
Walton, T. Contraindications to massage part IV: clinical thinking and cancer. Massage Therapy Journal 39(3): 66-83, 2000.
Field T, Hernandez-Reif M, Quintino O, Schanberg S, Kuhn C. Elder retired volunteers benefit from giving massage therapy to infants. Journal of Applied Gerontology 17(2): 229-239, 1998.
Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychogical Measure 1: 385-401, 1977.
Cresswell JW. Qualitative inquiry and research design: Choosing among five traditions. Thousand Oaks, Sage, 1998.

Responsible Party: Trish Dryden, RMT, M.Ed, Director, Applied Research Centre, Centennial College
ClinicalTrials.gov Identifier: NCT00698113     History of Changes
Other Study ID Numbers: CENT-SK-CAM07-323R, CAM 07-323R
Study First Received: June 12, 2008
Last Updated: June 17, 2009
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario
Canada: Health Canada

Keywords provided by Centennial College:
anxiety
depression
stress
cancer symptoms
pediatric cancer
massage
parent delivered massage

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 19, 2014