NCT00698113

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 19, 2009

Status Verified

June 1, 2008

Enrollment Period

2 years

First QC Date

June 12, 2008

Last Update Submit

June 17, 2009

Conditions

AnxietyDepressionStressPediatric Cancers

Keywords

anxietydepressionstresscancer symptomspediatric cancermassageparent delivered massage

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • My Story

    Week 6

  • Memorial Symptom Assessment Scale

    0, 6, 12 weeks

  • Pediatric Inventory for Parents

    0, 6, 12 weeks

  • Stait-Trait Anxiety Inventory for Adults

    0, 6, 12 weeks

  • The Center for Epidemiologic Studies Depression (CES-D) Scale

    0, 6, 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

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: MassageOther: Journaling

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

Interventions

MassagePROCEDURE

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.

Also known as: massage therapy
1
JournalingOTHER

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.

Also known as: reflection
12

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children aged 6 to 18 years
  • Children with a life expectancy of at least 12 weeks
  • Children who are currently receiving active cancer care

You may not qualify if:

  • Children under the age of 6
  • Children with a life expectancy of less than 12 weeks
  • Children not currently receiving active cancer care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Centennial College

Toronto, Ontario, M1K 5E9, Canada

ACTIVE NOT RECRUITING

Related Publications (34)

  • Moore IM. Advancing biobehavioral research in childhood cancer. J Pediatr Oncol Nurs. 2004 May-Jun;21(3):128-31. doi: 10.1177/1043454204264400.

    PMID: 15296039BACKGROUND

  • Boman K, Lindahl A, Bjork 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. doi: 10.1080/02841860310004995.

    PMID: 12801132BACKGROUND

  • 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. doi: 10.1053/jpon.2003.5.

    PMID: 12569433BACKGROUND

  • MacDonald G. Massage as a respite intervention for primary caregivers. Am J Hosp Palliat Care. 1998 Jan-Feb;15(1):43-7. doi: 10.1177/104990919801500109.

    PMID: 9468978BACKGROUND

  • Cavusoglu H. Depression in children with cancer. J Pediatr Nurs. 2001 Oct;16(5):380-5. doi: 10.1053/jpdn.2001.0000.

    PMID: 11598872BACKGROUND

  • Moyer CA, Rounds J, Hannum JW. A meta-analysis of massage therapy research. Psychol Bull. 2004 Jan;130(1):3-18. doi: 10.1037/0033-2909.130.1.3.

    PMID: 14717648BACKGROUND

  • 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. doi: 10.1016/j.jpainsymman.2003.12.016.

    PMID: 15336336BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • Fellowes D, Barnes K, Wilkinson S. Aromatherapy and massage for symptom relief in patients with cancer. Cochrane Database Syst Rev. 2004;(2):CD002287. doi: 10.1002/14651858.CD002287.pub2.

    PMID: 15106172BACKGROUND

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

    BACKGROUND

  • 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. doi: 10.1191/026921699678148345.

    PMID: 10659113BACKGROUND

  • 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. doi: 10.1097/00006199-200309000-00006.

    PMID: 14501546BACKGROUND

  • 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. doi: 10.1188/02.ONF.E35-E44.

    PMID: 11979292BACKGROUND

  • Bold J, Leis A. Unconventional therapy use among children with cancer in Saskatchewan. J Pediatr Oncol Nurs. 2001 Jan-Feb;18(1):16-25. doi: 10.1177/104345420101800103.

    PMID: 11172406BACKGROUND

  • Kazak AE. Evidence-based interventions for survivors of childhood cancer and their families. J Pediatr Psychol. 2005 Jan-Feb;30(1):29-39. doi: 10.1093/jpepsy/jsi013.

    PMID: 15610982BACKGROUND

  • 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.

    BACKGROUND

  • Gecsedi RA. Massage therapy for patients with cancer. Clin J Oncol Nurs. 2002 Jan-Feb;6(1):52-4. doi: 10.1188/02.CJON.52-54.

    PMID: 11842490BACKGROUND

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

    PMID: 11409061BACKGROUND

  • 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. doi: 10.1097/00002820-200401000-00004.

    PMID: 15108949BACKGROUND

  • Post-White J, Hawks RG. Complementary and alternative medicine in pediatric oncology. Semin Oncol Nurs. 2005 May;21(2):107-14; discussion 115-24. doi: 10.1016/j.soncn.2004.12.007.

    PMID: 15991661BACKGROUND

  • 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. doi: 10.1016/j.pec.2004.07.001.

    PMID: 16054796BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.7326/0003-4819-138-11-200306030-00011.

    PMID: 12779300BACKGROUND

  • 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. doi: 10.1097/00007632-200209010-00017.

    PMID: 12221356BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1016/s0885-3924(00)00127-5.

    PMID: 10869877BACKGROUND

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

    BACKGROUND

  • 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. doi: 10.1093/jpepsy/26.3.155.

    PMID: 11259517BACKGROUND

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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressionNeoplasms

Interventions

MassageMicroscopy, Interference

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInterferometryInvestigative Techniques

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Trish Dryden, RMT, M.Ed

CONTACT

416-289-5000tdryden@centennialcollege.ca

Stacey Neilson, BA (Hons), RMT

CONTACT

416-289-5999sneilson@rogers.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 16, 2008

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

June 19, 2009

Record last verified: 2008-06

Locations

CA(2)