Parent-Delivered Massage in Paediatric Cancer - Full Text View

Sponsors and Collaborators:	Centennial College SickKids Foundation Stollery Children's Hospital Canadian Institute of Natural and Integrative Medicine
Information provided by:	Centennial College
ClinicalTrials.gov Identifier:	NCT00698113

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

MedlinePlus related topics: Anxiety Cancer Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	Parent-Delivered Massage in Paediatric Cancer

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
1: 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.	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: 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.
2: 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.	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.

Arms

Assigned Interventions

1: 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.

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: 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.

2: 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.

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.

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

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

National Cancer Institute of Canada - Canadian Cancer Statistics 2005 This link exits the ClinicalTrials.gov site

Health Canada - Diagnosis and initial treatment of cancer in children in Canada 1995-2000 This link exits the ClinicalTrials.gov site

Leucan - Massage d'espoir This link exits the ClinicalTrials.gov site

College of Massage Therapists of Ontario This link exits the ClinicalTrials.gov site

Publications:

Moore IM. Advancing biobehavioral research in childhood cancer. J Pediatr Oncol Nurs. 2004 May-Jun;21(3):128-31. Review.

Boman K, Lindahl A, Björk O. Disease-related distress in parents of children with cancer at various stages after the time of diagnosis. Acta Oncol. 2003;42(2):137-46.

Trask PC, Paterson AG, Trask CL, Bares CB, Birt J, Maan C. Parent and adolescent adjustment to pediatric cancer: associations with coping, social support, and family function. J Pediatr Oncol Nurs. 2003 Jan-Feb;20(1):36-47.

MacDonald G. Massage as a respite intervention for primary caregivers. Am J Hosp Palliat Care. 1998 Jan-Feb;15(1):43-7.

Cavuşoğlu H. Depression in children with cancer. J Pediatr Nurs. 2001 Oct;16(5):380-5.

Moyer CA, Rounds J, Hannum JW. A meta-analysis of massage therapy research. Psychol Bull. 2004 Jan;130(1):3-18.

Cassileth BR, Vickers AJ. Massage therapy for symptom control: outcome study at a major cancer center. J Pain Symptom Manage. 2004 Sep;28(3):244-9.

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

Fellowes D, Barnes K, Wilkinson S. Aromatherapy and massage for symptom relief in patients with cancer. Cochrane Database Syst Rev. 2004;(2):CD002287. Review.

Laizner AM, Lussier L. Massage program relives suffering for parents while provides comfort for children. Journal of Complementary & Integrative Medicine 2(1): 35, 2005.

Wilkinson S, Aldridge J, Salmon I, Cain E, Wilson B. An evaluation of aromatherapy massage in palliative care. Palliat Med. 1999 Sep;13(5):409-17.

Goodfellow LM. The effects of therapeutic back massage on psychophysiologic variables and immune function in spouses of patients with cancer. Nurs Res. 2003 Sep-Oct;52(5):318-28.

Rexilius SJ, Mundt C, Erickson Megel M, Agrawal S. Therapeutic effects of massage therapy and handling touch on caregivers of patients undergoing autologous hematopoietic stem cell transplant. Oncol Nurs Forum. 2002 Apr;29(3):E35-44.

Bold J, Leis A. Unconventional therapy use among children with cancer in Saskatchewan. J Pediatr Oncol Nurs. 2001 Jan-Feb;18(1):16-25.

Kazak AE. Evidence-based interventions for survivors of childhood cancer and their families. J Pediatr Psychol. 2005 Jan-Feb;30(1):29-39. Review.

Gecsedi RA. Massage therapy for patients with cancer. Clin J Oncol Nurs. 2002 Jan-Feb;6(1):52-4. Review.

Billhult A, Dahlberg K. A meaningful relief from suffering experiences of massage in cancer care. Cancer Nurs. 2001 Jun;24(3):180-4.

Forchuk C, Baruth P, Prendergast M, Holliday R, Bareham R, Brimner S, Schulz V, Chan YC, Yammine N. Postoperative arm massage: a support for women with lymph node dissection. Cancer Nurs. 2004 Jan-Feb;27(1):25-33.

Post-White J, Hawks RG. Complementary and alternative medicine in pediatric oncology. Semin Oncol Nurs. 2005 May;21(2):107-14; discussion 115-24. Review.

Santo A, Laizner AM, Shohet L. Exploring the value of audiotapes for health literacy: a systematic review. Patient Educ Couns. 2005 Sep;58(3):235-43. Review.

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.

Cherkin DC, Sherman KJ, Deyo RA, Shekelle PG. A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain. Ann Intern Med. 2003 Jun 3;138(11):898-906. Review.

Furlan AD, Brosseau L, Imamura M, Irvin E. Massage for low-back pain: a systematic review within the framework of the Cochrane Collaboration Back Review Group. Spine. 2002 Sep 1;27(17):1896-910. Review.

Curties D. Massage therapy and cancer. Moncton, NB: Curties-Overzet Publications, 1988.

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.

Collins JJ, Byrnes ME, Dunkel IJ, Lapin J, Nadel T, Thaler HT, Polyak T, Rapkin B, Portenoy RK. The measurement of symptoms in children with cancer. J Pain Symptom Manage. 2000 May;19(5):363-77.

Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62.

Responsible Party:	Applied Research Centre, Centennial College ( Trish Dryden, RMT, M.Ed, Director )
Study ID Numbers:	CENT-SK-CAM07-323R, CAM 07-323R
Study First Received:	June 12, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00698113
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

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Stress
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009