Pediatric CancerNCT04067687
Home Visit Intervention in Pediatric Palliative Care
A study testing Palliative home visit in people with Pediatric Cancer and Palliative, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pediatric Cancer, Palliative
- What is being tested?
- Palliative home visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients who live outside Jakarta and therefore unreachable to get palliative intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pediatric Cancer, Palliative
- Being tested
- Palliative home visit
- Keywords
- palliative, cancer, pediatric
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative home visitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No palliative home visit intervention |
| Intervention | Experimental | Palliative home visit intervention Receives: Other: Palliative home visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of 3 months follow up
Secondary outcomes (2)
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.
Measured: 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.
Measured: during 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm of control group and intervention group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murti Andriastuti, Doctor, Universitas Indonesia
- Investigators
- Murti Andriastuti, Doctor, Principal investigator, Indonesia University, Cipto Mangunkusumo Hospital Jakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067687
- Sponsor's protocol ID
- PedPalliative01
- Status last verified
- Dec 2019
- First submitted
- 22 Aug 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Intervention to Improve Quality of Life in Children With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04067687
- Acronym / sponsor ID
- PedPalliative01
- Conditions
- Pediatric Cancer, Palliative
- Keywords
- palliative, cancer, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm of control group and intervention group
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No palliative home visit intervention |
| Intervention | Experimental | Other: Palliative home visitPalliative home visit intervention |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who live outside Jakarta and therefore unreachable to get palliative intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative home visita 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. | Other | Intervention |
Primary outcome
Quality of life cancer child
Time frame: at the end of 3 months follow up
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.
2 secondary outcomes
Emergency room visits
Time frame: during 3 months follow up
Symptomps intensity
Time frame: during 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Pediatric Cancer
Active, not recruitingPhase 1/2
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Not yet recruitingObservational study
Implementation Development for Distress Screening in Pediatric Oncology (ID-DISTRESSS)
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
Glioblastoma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murti Andriastuti, Doctor principal investigator
Indonesia University, Cipto Mangunkusumo Hospital Jakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative home visit in people with Pediatric Cancer and Palliative, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life cancer child (time frame: at the end of 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.