AnxietyNCT00698113
Parent-Delivered Massage in Paediatric Cancer
A study testing Massage and Journaling in people with Anxiety and Depression, run by Centennial College at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anxiety, Depression, Stress
- What is being tested?
- Massage and Journaling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6 to 18 years
- Children with a life expectancy of at least 12 weeks
- Children who are currently receiving active cancer care
Who cannot join
- Children under the age of 6
- Children with a life expectancy of less than 12 weeks
- Children not currently receiving active cancer care
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 1 recruiting
- Recruiting
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Linda Churcher, CCRP, 780-407-8790, lindachurcher@cha.ab.ca
Ronda Blasco, 780-407-2056, Ronda.Blasco@capitalhealth.ca
- Active, not recruiting
Centennial College
Toronto, Ontario, M1K 5E9
About this study
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.
Read the 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.
- Conditions
- Anxiety, Depression, Stress, Pediatric Cancers
- Being tested
- Massage, Journaling
- Keywords
- anxiety, depression, stress, cancer symptoms, pediatric cancer, massage, parent delivered massage
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageProcedure or surgery
Also called massage therapy
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.
JournalingOther
Also called reflection
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Massage; Other: 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. Receives: Other: Journaling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Period of study
Secondary outcomes (8)
My Story
Measured: Week 6
Memorial Symptom Assessment Scale
Measured: 0, 6, 12 weeks
Pediatric Inventory for Parents
Measured: 0, 6, 12 weeks
Stait-Trait Anxiety Inventory for Adults
Measured: 0, 6, 12 weeks
The Center for Epidemiologic Studies Depression (CES-D) Scale
Measured: 0, 6, 12 weeks
State-Trait Anxiety Inventory for Children
Measured: 0, 6, 12 weeks
Parent Journals
Measured: Weekly for 6 weeks
Child Journals
Measured: Weekly for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centennial College
- Sponsor type
- University, hospital or other
- Collaborators
- SickKids Foundation, Stollery Children's Hospital, Canadian Institute of Natural and Integrative Medicine
- Investigators
- Trish Dryden, RMT, M.Ed, Principal investigator, Applied Research Centre, Centennial CollegeSabine Moritz, Dipl. Biol., M.Sc, Principal investigator, Canadian Institute of Natural and Integrative MedicineSunita Vohra, MD, FRCPC, M.Sc, Principal investigator, Stollery Children's Hospital & University of AlbertaDawn Davies, MD, FRCPC, Principal investigator, Stollery Children's HospitalAdrienne D Witol, Psy.D., C.Psych, Principal investigator, Stollery Children's HospitalAndrea M Laizner, RN, Ph.D, Principal investigator, Centre de recherché Hôpital Sainte-Justine CHU Mère-Enfant & McGill University Health CentreLyse Lussier, Principal investigator, Le Phare enfants et famillesJanet Kahn, LMT, Ph.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698113
- Sponsor's protocol ID
- CENT-SK-CAM07-323R
- Other IDs
- CAM 07-323R
- Status last verified
- Jun 2008
- First submitted
- 12 Jun 2008
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moore IM. Advancing biobehavioral research in childhood cancer. J Pediatr Oncol Nurs. 2004 May-Jun;21(3):128-31. doi: 10.1177/1043454204264400.
PubMed 15296039Boman 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.
PubMed 12801132Trask 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.
PubMed 12569433MacDonald 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.
PubMed 9468978Cavusoglu H. Depression in children with cancer. J Pediatr Nurs. 2001 Oct;16(5):380-5. doi: 10.1053/jpdn.2001.0000.
PubMed 11598872Moyer 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.
PubMed 14717648Cassileth 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.
PubMed 15336336Field 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.
Laizner AM, Lussier L. Massage provides comfort to children with cancer: the child's perspective. Journal of Complementary & Integrative Medicine 2(1): 34, 2005
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.
PubMed 15106172Laizner AM, Lussier L. Massage program relives suffering for parents while provides comfort for children. Journal of Complementary & Integrative Medicine 2(1): 35, 2005.
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.
PubMed 10659113Goodfellow 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.
PubMed 14501546Rexilius 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.
PubMed 11979292Bold 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.
PubMed 11172406
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Delivered Massage in Paediatric Cancer
- ClinicalTrials.gov ID
- NCT00698113
- Acronym / sponsor ID
- CENT-SK-CAM07-323R
- Conditions
- Anxiety, Depression, Stress, Pediatric Cancers
- Keywords
- anxiety, depression, stress, cancer symptoms, pediatric cancer, massage, parent delivered massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centennial CollegeUniversity, hospital or other
- Collaborators
- SickKids Foundation, Stollery Children's Hospital, Canadian Institute of Natural and Integrative Medicine
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Massage, Other: JournalingThis group receives the massage intervention for a period of six weeks. Children and parents are asked to journal weekly for the six week period. |
| 2 | No intervention | Other: JournalingThe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 6 to 18 years
- Children with a life expectancy of at least 12 weeks
- Children who are currently receiving active cancer care
Key exclusion criteria (3 listed)
- Children under the age of 6
- Children with a life expectancy of less than 12 weeks
- Children not currently receiving active cancer care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MassageAlso: massage therapyChildren 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. | Procedure or surgery | 1 |
| JournalingAlso: reflectionChildren 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 | 1, 2 |
Primary outcome
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
8 secondary outcomes
My Story
Time frame: Week 6
Memorial Symptom Assessment Scale
Time frame: 0, 6, 12 weeks
Pediatric Inventory for Parents
Time frame: 0, 6, 12 weeks
Stait-Trait Anxiety Inventory for Adults
Time frame: 0, 6, 12 weeks
The Center for Epidemiologic Studies Depression (CES-D) Scale
Time frame: 0, 6, 12 weeks
State-Trait Anxiety Inventory for Children
Time frame: 0, 6, 12 weeks
Parent Journals
Time frame: Weekly for 6 weeks
Child Journals
Time frame: Weekly for 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
- Background: PubMed 15296039Moore IM. Advancing biobehavioral research in childhood cancer. J Pediatr Oncol Nurs. 2004 May-Jun;21(3):128-31. doi: 10.1177/1043454204264400.
- Background: PubMed 12801132Boman 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.
- Background: PubMed 12569433Trask 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.
- Background: PubMed 9468978MacDonald 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.
- Background: PubMed 11598872Cavusoglu H. Depression in children with cancer. J Pediatr Nurs. 2001 Oct;16(5):380-5. doi: 10.1053/jpdn.2001.0000.
- Background: PubMed 14717648Moyer 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.
- Background: PubMed 15336336Cassileth 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.
- BackgroundField 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.
- BackgroundLaizner AM, Lussier L. Massage provides comfort to children with cancer: the child's perspective. Journal of Complementary & Integrative Medicine 2(1): 34, 2005
- Background: PubMed 15106172Fellowes 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.
- BackgroundLaizner AM, Lussier L. Massage program relives suffering for parents while provides comfort for children. Journal of Complementary & Integrative Medicine 2(1): 35, 2005.
- Background: PubMed 10659113Wilkinson 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.
- Leucan - Massage d'espoirLink provided by the sponsor.
- College of Massage Therapists of OntarioLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trish Dryden, RMT, M.Ed principal investigator
Applied Research Centre, Centennial College
Sabine Moritz, Dipl. Biol., M.Sc principal investigator
Canadian Institute of Natural and Integrative Medicine
Sunita Vohra, MD, FRCPC, M.Sc principal investigator
Stollery Children's Hospital & University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and Journaling in people with Anxiety and Depression, run by Centennial College at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trish Dryden, RMT, M.Ed (416-289-5000 ext. 8056, tdryden@centennialcollege.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698113, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2009.