Parent-Delivered Massage in Paediatric Cancer
Primary Purpose
Anxiety, Depression, Stress
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Massage
Journaling
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety focused on measuring anxiety, depression, stress, cancer symptoms, pediatric cancer, massage, parent delivered massage
Eligibility 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
Sites / Locations
- Stollery Children's HospitalRecruiting
- Centennial College
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
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.
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.
Outcomes
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.
Secondary Outcome Measures
My Story
Memorial Symptom Assessment Scale
Pediatric Inventory for Parents
Stait-Trait Anxiety Inventory for Adults
The Center for Epidemiologic Studies Depression (CES-D) Scale
State-Trait Anxiety Inventory for Children
Parent Journals
Child Journals
Full Information
NCT ID
NCT00698113
First Posted
June 12, 2008
Last Updated
June 17, 2009
Sponsor
Centennial College
Collaborators
SickKids Foundation, Stollery Children's Hospital, Canadian Institute of Natural and Integrative Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00698113
Brief Title
Parent-Delivered Massage in Paediatric Cancer
Official Title
Parent-Delivered Massage in Paediatric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Centennial College
Collaborators
SickKids Foundation, Stollery Children's Hospital, Canadian Institute of Natural and Integrative Medicine
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Stress, Pediatric Cancers
Keywords
anxiety, depression, stress, cancer symptoms, pediatric cancer, massage, parent delivered massage
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Massage
Other Intervention Name(s)
massage therapy
Intervention Description
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
Other
Intervention Name(s)
Journaling
Other Intervention Name(s)
reflection
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
My Story
Time Frame
Week 6
Title
Memorial Symptom Assessment Scale
Time Frame
0, 6, 12 weeks
Title
Pediatric Inventory for Parents
Time Frame
0, 6, 12 weeks
Title
Stait-Trait Anxiety Inventory for Adults
Time Frame
0, 6, 12 weeks
Title
The Center for Epidemiologic Studies Depression (CES-D) Scale
Time Frame
0, 6, 12 weeks
Title
State-Trait Anxiety Inventory for Children
Time Frame
0, 6, 12 weeks
Title
Parent Journals
Time Frame
Weekly for 6 weeks
Title
Child Journals
Time Frame
Weekly for 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trish Dryden, RMT, M.Ed
Phone
416-289-5000
Ext
8056
Email
tdryden@centennialcollege.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Neilson, BA (Hons), RMT
Phone
416-289-5999
Ext
8397
Email
sneilson@rogers.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trish Dryden, RMT, M.Ed
Organizational Affiliation
Applied Research Centre, Centennial College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabine Moritz, Dipl. Biol., M.Sc
Organizational Affiliation
Canadian Institute of Natural and Integrative Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sunita Vohra, MD, FRCPC, M.Sc
Organizational Affiliation
Stollery Children's Hospital & University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dawn Davies, MD, FRCPC
Organizational Affiliation
Stollery Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrienne D Witol, Psy.D., C.Psych
Organizational Affiliation
Stollery Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea M Laizner, RN, Ph.D
Organizational Affiliation
Centre de recherché Hôpital Sainte-Justine CHU Mère-Enfant & McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lyse Lussier
Organizational Affiliation
Le Phare enfants et familles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Kahn, LMT, Ph.D.
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda Baskwill, RMT
Organizational Affiliation
Centennial College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Curcher, CCRP
Organizational Affiliation
Stollery Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Barberree, RMT
Organizational Affiliation
Massage Therapist Association of Alberta (MTAA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Churcher, CCRP
Phone
780-407-8790
Email
lindachurcher@cha.ab.ca
First Name & Middle Initial & Last Name & Degree
Ronda Blasco
Phone
780-407-2056
Email
Ronda.Blasco@capitalhealth.ca
First Name & Middle Initial & Last Name & Degree
Linda Churcher, CCRP
Facility Name
Centennial College
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1K 5E9
Country
Canada
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
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Links:
URL
http://www.ncic.cancer.ca/Cancer%20control/Canadian%20Cancer%20Statistics.aspx
Description
National Cancer Institute of Canada - Canadian Cancer Statistics 2005
URL
http://leucan.qc.ca/en
Description
Leucan - Massage d'espoir
URL
http://www.cmto.com/index.html
Description
College of Massage Therapists of Ontario
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Parent-Delivered Massage in Paediatric Cancer
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