Home Visit Intervention in Pediatric Palliative Care

NCT04067687 | Completed DMC

• 1 other identifier: PedPalliative01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer; Palliative

Keywords

palliative; cancer; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Emergency room visits

  during 3 months follow up

• Symptomps intensity

  during 3 months follow up

Study Arms (2)

Control

NO INTERVENTION

No palliative home visit intervention

Intervention

EXPERIMENTAL

Palliative home visit intervention

Other: Palliative home visit

Interventions

Palliative home visit OTHER

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.

Intervention

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Murti Andriastuti, Doctor

  Indonesia University, Cipto Mangunkusumo Hospital Jakarta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two arm of control group and intervention group

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: January 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: September 30, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)