Pediatric Integrative Medicine Trial Pilot (PIM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Alberta
Sponsor:
Collaborator:
Lotte & John Hecht Memorial Foundation
Information provided by (Responsible Party):
Sunita Vohra, University of Alberta
ClinicalTrials.gov Identifier:
NCT02028832
First received: December 16, 2013
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

This study will investigate if adding complementary therapies such as acupuncture, massage and reiki to inpatient pediatric cancer care is feasible and what the effects are on outcomes such as patient symptoms, cost, safety, satisfaction and length of stay.


Condition Intervention Phase
Pain
Nausea
Vomiting
Anxiety
Procedure: Pediatric Integrative Medicine consult and service provision
Procedure: Usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Enrollment [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
    Enrollment of study participants over length of study which will inform conduct of a larger study in this population


Secondary Outcome Measures:
  • Change in pain [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
  • Change in nausea/vomiting [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
  • Change in anxiety [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ]
  • Parent satisfaction with patient care [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
  • Change in other clinical symptoms [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Resource Utilization/Cost [ Time Frame: Analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days ] [ Designated as safety issue: No ]
    Resource utilization and related costs will be compared between study arms


Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care
Usual care provided to pediatric oncology inpatients
Procedure: Usual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
Experimental: PIM consult and service provision
Pediatric integrative medicine service (PIM) through which pediatric oncology inpatients will have the option of supplementing their usual care with acupuncture/acupressure, massage, and/or reiki
Procedure: Pediatric Integrative Medicine consult and service provision
If service is requested, treatment options include acupuncture/acupressure, massage, and reiki
Procedure: Usual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.

Detailed Description:

Study Objective: To determine if a pediatric integrative medicine (PIM) service is effective in reducing overall symptoms of pain, nausea/vomiting, and/or anxiety (PNVA), length of stay, and costs, in hospitalized children when compared to conventional care. In this context, "integrative" refers to a combined approach of complementary and conventional medical therapies in an evidence-based fashion.

Design: cluster trial; 2-arm controlled evaluation study in pediatric oncology. Intervention will be offered during a 6-month PIM period following a 6 month control period.

Population: Inclusion criteria: (i) In-patients in pediatric oncology 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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (i) all children, aged 0-16 years, who are admitted to Pediatric Oncology at the Stollery Children's Hospital, Edmonton, Canada who
  • (ii) can communicate in English; and
  • (iii) give informed consent/assent

Exclusion Criteria:

  • (i) cannot communicate in English;
  • (ii) lack of parent availability to participate; or
  • iii) lack of informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028832

Contacts
Contact: Sunita Vohra, MD, MSc 780-342-8592 care@ualberta.ca
Contact: Denise Adams, PhD 780-342-8504 denise.adams@ualberta.ca

Locations
Canada, Alberta
Stollery Childrens' Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Denise Adams, PhD    780-342-8504    denise.adams@ualberta.ca   
Contact: Hsing Jou, MC         
Principal Investigator: Sunita Vohra, MD, MSc         
Sponsors and Collaborators
University of Alberta
Lotte & John Hecht Memorial Foundation
Investigators
Principal Investigator: Sunita Vohra, MD, MSc University of Alberta
  More Information

No publications provided

Responsible Party: Sunita Vohra, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02028832     History of Changes
Other Study ID Numbers: PIM1
Study First Received: December 16, 2013
Last Updated: January 6, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
pain
nausea/vomiting
anxiety
complementary and alternative medicine
pediatric
oncology
cost-effectiveness

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014