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Home Visit Intervention in Pediatric Palliative Care

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04067687
Enrollment
60
Registered
2019-08-26
Start date
2019-01-01
Completion date
2019-09-30
Last updated
2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palliative, Pediatric Cancer

Keywords

palliative, cancer, pediatric

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.

Interventions

OTHERPalliative 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.

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Two arm of control group and intervention group

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life cancer childat the end of 3 months follow upMeasured 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.

Secondary

MeasureTime frameDescription
Emergency room visitsduring 3 months follow upFrequency of emergency room visit is recorded during 3-months follow up period. Total number of emergency rom visits will be summed.
Symptomps intensityduring 3 months follow upMeasured 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.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026