Study Results
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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COMPLETED
PHASE3
872 participants
INTERVENTIONAL
2013-02-28
2016-09-30
Brief Summary
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Detailed Description
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Design: cluster trial; 2-arm controlled evaluation study in pediatric oncology, general pediatrics and pediatric cardiology. Intervention will be offered during a 6-month PIM period following a 6 month control period.
Population: Inclusion criteria: (i) In-patients in participating division and (ii) informed consent/assent. Exclusion criteria: (i) lack of parent participation, fluency in English, or informed consent
Intervention: Recommendations for specific CAM therapies will be determined by a staff PIM pediatrician. Any combination of the following CAM therapies (dose, duration, amount to be based on patient need as assessed by CAM provider, patient, and parent): acupuncture/acupressure, massage, Reiki; all are to be offered in addition to usual care.
Control: Usual care.
Outcomes: Primary outcome: feasibility (i.e enrollment); Secondary outcomes: (i) PNVA symptom management, (ii) need for conventional pharmacotherapy, (iii) adverse events; (iv) parent and health care provider satisfaction with care provided, v) length of stay; and vi) cost-effectiveness (analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days).
Significance: To our knowledge, this study will be the first comparative effectiveness trial to assess the impact of PIM for hospitalized children with cancer.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual care
Usual care provided to pediatric inpatients
Usual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
PIM consult and service provision
Pediatric integrative medicine service (PIM) through which pediatric inpatients will have the option of supplementing their usual care with acupuncture/acupressure, massage, and/or reiki
PIM consult and service provision
If service is requested, treatment options include acupuncture/acupressure, massage, and reiki
Usual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
Interventions
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PIM consult and service provision
If service is requested, treatment options include acupuncture/acupressure, massage, and reiki
Usual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
Eligibility Criteria
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Inclusion Criteria
* (ii) can communicate in English; and
* (iii) give informed consent/assent
Exclusion Criteria
* (ii) lack of parent availability to participate; or
* iii) lack of informed consent.
16 Years
ALL
No
Sponsors
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Lotte & John Hecht Memorial Foundation
OTHER
University of Alberta
OTHER
Responsible Party
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Sunita Vohra
Professor
Principal Investigators
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Sunita Vohra, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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Stollery Childrens' Hospital
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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PIM1
Identifier Type: -
Identifier Source: org_study_id
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