Parent-Delivered Massage in Paediatric Cancer

Depression Clinical Trial

Official title:

Parent-Delivered Massage in Paediatric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00698113
• Other study ID #: CENT-SK-CAM07-323R
• Secondary ID: CAM 07-323R
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2008
• Last updated: June 17, 2009
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2008
• Source: Centennial College
• Contact: Trish Dryden, RMT, M.Ed
• Phone: 416-289-5000
• Email: tdryden[@]centennialcollege.ca
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, OntarioCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Depression
• Pediatric Cancers
• Stress

Intervention

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.

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	Centennial College	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Centennial College	Canadian Institute of Natural and Integrative Medicine, SickKids Foundation, Stollery Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (34)

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

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

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. — View Citation

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. — View Citation

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

Chambers B, Cheun A, Gifford R, Madden N. Achievement effects of embedded multimedia in a success for all reading program. Success for All Foundation (Grant No. REC 0115659): John Hopkins, 2004.

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. — View Citation

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. — View Citation

Cresswell JW. Qualitative inquiry and research design: Choosing among five traditions. Thousand Oaks, Sage, 1998.

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

Fellowes D, Barnes K, Wilkinson S. Aromatherapy and massage for symptom relief in patients with cancer. Cochrane Database Syst Rev. 2004;(2):CD002287. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD002287. — View Citation

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.

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.

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. — View Citation

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 (Phila Pa 1976). 2002 Sep 1;27(17):1896-910. Review. — View Citation

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

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. — View Citation

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

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

Laizner AM, Lussier L. Massage provides comfort to children with cancer: the child's perspective. Journal of Complementary & Integrative Medicine 2(1): 34, 2005

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

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

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

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.

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. — View Citation

Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychogical Measure 1: 385-401, 1977.

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. — View Citation

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. — View Citation

Spielberger CD, Edwards CD, Lushene RE, Montuori J, Platzek D. STAIC preliminary manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press Inc., 1973.

Spielberger CD, Gorsuch RC, Lushene RE. The State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press, 1970.

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. — View Citation

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. — View Citation

Walton, T. Contraindications to massage part IV: clinical thinking and cancer. Massage Therapy Journal 39(3): 66-83, 2000.

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. — View Citation

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Period of study	No
Secondary	My Story		Week 6	No
Secondary	Memorial Symptom Assessment Scale		0, 6, 12 weeks	No
Secondary	Pediatric Inventory for Parents		0, 6, 12 weeks	No
Secondary	Stait-Trait Anxiety Inventory for Adults		0, 6, 12 weeks	No
Secondary	The Center for Epidemiologic Studies Depression (CES-D) Scale		0, 6, 12 weeks	No
Secondary	State-Trait Anxiety Inventory for Children		0, 6, 12 weeks	No
Secondary	Parent Journals		Weekly for 6 weeks	No
Secondary	Child Journals		Weekly for 6 weeks	No

External Links

•   Leucan - Massage d'espoir
•   National Cancer Institute of Canada - Canadian Cancer Statistics 2005