Home Visit Intervention in Pediatric Palliative Care

Palliative Intervention to Improve Quality of Life in Children With Cancer: A Randomized Controlled Trial

A randomized controlled trial to compare the quality of life between participants who were given palliative care (a 3-month home visit) and those who were not (intervention vs control group) was conducted. Participants consisted of children with cancer aged 2-18 years old. A two-way communication between a trained health worker and participants with or without their parents were conducted as the intervention (report by proxy or self-report). Interventions were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education, symptoms management, self-care, communication, decision making, and long-term care plan assistance. In the first and twelfth week of the intervention, all participants were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0. Symptomps intensityof anorexia, sleep diturbance, and pain will be asessed in each visit. Participants were followed, Emergency Room (ER) admissions were recorded during follow up period. During the follow up period, ER admissions were recorded further.

Study Overview

• Status: Completed
• Conditions: Pediatric Cancer; Palliative
• Intervention / Treatment: Other: Palliative home visit

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Child age 2-18 years old with malignancies who undergo treatments at the Department of Child Health of Cipto Mangunkusumo Hospital, during the study period.
• All participants who meet the criteria to get palliative care, participants with a total score ≥ 4 based on palliative screening form.
• Participants and or parents agree to be enrolled in study

Exclusion Criteria:

• Patients who live outside Jakarta and therefore unreachable to get palliative intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No palliative home visit intervention
EXPERIMENTAL: Intervention; Palliative home visit intervention	Other: Palliative home visit; a 3-month home visit, providing two-way communication between a trained health worker and patients with or without their parents were conducted as the intervention (report by proxy or self-report). Interventions were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education, symptoms management, self-care, communication, decision making, and long-term care plan assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life cancer child	Measured using PedsQLTM cancer module 3.0 that consisted of eight dimension. Each dimension consisted of several items to be answered. Item scaling was answered in 5-point Likert scale from 0 (Never) to 4 (Almost always). Scores are transformed to a 0 to 100 scale. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. If more than 50% of the items in the scale are missing, the scale scores should not be computed. Mean score = Sum of the items over the number of items answered. Total score is acquired by summing of all the items over the number of items answered on all the Scales.Higher scores indicate lower problems.	at the end of 3 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency room visits	Frequency of emergency room visit is recorded during 3-months follow up period. Total number of emergency rom visits will be summed.	during 3 months follow up
Symptomps intensity	Measured using Edmonton Symptoms Asessment Scale. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity. The patient and family should be taught how to complete the scales. Mean score is acquired by summing all scores then divided it by total number of assesment.	during 3 months follow up

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Murti Andriastuti, Doctor, Indonesia University, Cipto Mangunkusumo Hospital Jakarta

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (ACTUAL): August 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: cancer; pediatric; palliative
• Other Study ID Numbers: PedPalliative01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No