Parent-Delivered Massage in Paediatric Cancer

Sponsor

Centennial College (Other)

Overall Status

Unknown status

CT.gov ID

NCT00698113

Collaborator

SickKids Foundation (Other), Stollery Children's Hospital (Other), Canadian Institute of Natural and Integrative Medicine (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Stress Pediatric Cancers	Procedure: Massage Other: Journaling	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Parent-Delivered Massage in Paediatric Cancer

Study Start Date :

Apr 1, 2007

Anticipated Primary Completion Date :

Apr 1, 2009

Anticipated Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: reflection

Arm

Intervention/Treatment

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 Names:

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 Names:

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

Other Names:

reflection

Outcome Measures

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. [Period of study]

Secondary Outcome Measures

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]
State-Trait Anxiety Inventory for Children [0, 6, 12 weeks]
Parent Journals [Weekly for 6 weeks]
Child Journals [Weekly for 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stollery Children's Hospital	Edmonton	Alberta	Canada	T6G 2B7
2	Centennial College	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)