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Medi-Port Pilot Randomized Controlled Trial

NCT02611739 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-03

No results posted yet for this study

Summary

Pain is a frequent and significant problem related to cancer-directed treatment in children. Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is capable of facilitating distraction and reducing distress during childhood immunizations. Our research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port) for effectiveness testing in a future RCT (measured as implementation outcomes) and (2) determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes), compared to standard medical care.

Conditions

  • Actively Undergoing Cancer Treatment
  • 4-9 Years of Age
  • At Least 1 Month From Diagnosis
  • Able to Speak and Understand English
  • Presenting to Clinic for at Least a 2nd Subcutaneous Port Needle Insertion

Interventions

DEVICE

Medi-Port

Treatment

DEVICE

Medi-Port

Control

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Jennifer Stinson, RN, PhD · The Hospital for Sick Children

  • Paul Nathan, MD · The Hospital for Sick Children

  • Tanya Beran, PhD, RPsych · University of Calgary

  • Lindsay Jibb, RN, MSc · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611739 on ClinicalTrials.gov