Parent-Delivered Massage in Paediatric Cancer

NCT ID: NCT00698113

Last Updated: 2009-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Depression Stress Pediatric Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Massage

Intervention Type PROCEDURE

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.

Journaling

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

Journaling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Other Intervention Names

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massage therapy reflection

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SickKids Foundation

OTHER

Sponsor Role collaborator

Stollery Children's Hospital

OTHER

Sponsor Role collaborator

Canadian Institute of Natural and Integrative Medicine

OTHER

Sponsor Role collaborator

Centennial College

OTHER

Sponsor Role lead

Responsible Party

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Applied Research Centre, Centennial College

Principal Investigators

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Trish Dryden, RMT, M.Ed

Role: PRINCIPAL_INVESTIGATOR

Applied Research Centre, Centennial College

Sabine Moritz, Dipl. Biol., M.Sc

Role: PRINCIPAL_INVESTIGATOR

Canadian Institute of Natural and Integrative Medicine

Sunita Vohra, MD, FRCPC, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Stollery Children's Hospital & University of Alberta

Dawn Davies, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Stollery Children's Hospital

Adrienne D Witol, Psy.D., C.Psych

Role: PRINCIPAL_INVESTIGATOR

Stollery Children's Hospital

Andrea M Laizner, RN, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Centre de recherché Hôpital Sainte-Justine CHU Mère-Enfant & McGill University Health Centre

Lyse Lussier

Role: PRINCIPAL_INVESTIGATOR

Le Phare enfants et familles

Janet Kahn, LMT, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Amanda Baskwill, RMT

Role: PRINCIPAL_INVESTIGATOR

Centennial College

Linda Curcher, CCRP

Role: PRINCIPAL_INVESTIGATOR

Stollery Children's Hospital

Elizabeth Barberree, RMT

Role: PRINCIPAL_INVESTIGATOR

Massage Therapist Association of Alberta (MTAA)

Locations

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Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status RECRUITING

Centennial College

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Countries

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Canada

Central Contacts

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Trish Dryden, RMT, M.Ed

Role: CONTACT

416-289-5000 ext. 8056

Stacey Neilson, BA (Hons), RMT

Role: CONTACT

416-289-5999 ext. 8397

Facility Contacts

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Linda Churcher, CCRP

Role: primary

780-407-8790

Ronda Blasco

Role: backup

780-407-2056

References

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Reference Type BACKGROUND
PMID: 15296039 (View on PubMed)

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Reference Type BACKGROUND

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Reference Type BACKGROUND
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Reference Type BACKGROUND

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Related Links

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http://leucan.qc.ca/en

Leucan - Massage d'espoir

http://www.cmto.com/index.html

College of Massage Therapists of Ontario

Other Identifiers

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CAM 07-323R

Identifier Type: -

Identifier Source: secondary_id

CENT-SK-CAM07-323R

Identifier Type: -

Identifier Source: org_study_id

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