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Home Visit Intervention in Pediatric Palliative Care

NCT ID: NCT04067687

Last Updated: 2019-12-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Cancer Palliative

Keywords

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palliative cancer pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm of control group and intervention group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

No palliative home visit intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Palliative home visit intervention

Group Type EXPERIMENTAL

Palliative home visit

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Murti Andriastuti, Doctor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murti Andriastuti, Doctor

Role: PRINCIPAL_INVESTIGATOR

Indonesia University, Cipto Mangunkusumo Hospital Jakarta

Locations

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Cipto Mangunkusumo Hospital

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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PedPalliative01

Identifier Type: -

Identifier Source: org_study_id