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Pediatric Acute Myeloid LeukemiaeHOPENCT05455268

Information Support Using an Online Learning Platform for Malaysian Pediatric Leukemia and Lymphoma Parents

A study testing eHOPE in people with Pediatric Acute Myeloid Leukemia and Pediatric Acute Lymphoid Leukemia, run by Universiti Kebangsaan Malaysia Medical Centre at 2 sites in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study protocol to determine whether it is feasible to support parents of children with blood cancers by providing information over an online learning platform. This study will be conducted in Malaysia. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
eHOPE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
2 sitesMalaysia
Study dates
15 Jul 2022to 31 Mar 2023
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Child (age <18 years) is diagnosed with either leukemia or lymphoma in the 3 months preceding recruitment
  • Child is receiving care from either study site
  • Able to access internet for health information via a computer, tablet or a mobile device
  • Able to read and understand Malay language

Who cannot join

  • Child is transferred to other hospital for continuation of treatment
  • Extreme psychological distress
  • Partner or spouse already enrolled into the current trial

Trial locations and contacts

2 sites in 1 country.

Malaysia2 sites

  • Hospital Tunku Azizah

    Kuala Lumpur, 50300

  • Hospital Tunku Ampuan Besar Tuanku Aishah Rohani Hospital Pakar Kanak-kanak UKM (HPKK)

    Kuala Lumpur, 56000

Other trials in Malaysia

About this study

Official title: Feasibility of e-Hematology Oncology Parents Education (eHOPE) for Information Support Among Malaysian Parents of Children With Hematological Cancer

This is a study protocol to determine whether it is feasible to support parents of children with blood cancers by providing information over an online learning platform. This study will be conducted in Malaysia. An online learning platform will be used to provide information relevant to parents who care for children diagnosed with leukemia or lymphoma. The use of this platform will be compared with current usual care, where only verbal discussions and ad hoc caregiver training is provided to support these parents, based on the clinician's judgement. Participants knowledge and confidence level in caregiving as well as coping will be compared between the two groups. To determine the feasibility of this method of information support, the researchers will also obtain feedback from participants who used the online learning platform and determine whether there are many who drop out from using it. The findings will determine whether use of online learning platform is suitable to deliver information support for parents, in view of currently limited resources for supportive care in childhood cancer care in Malaysia.

Read the detailed description

This is the study protocol for a multi-centre interventional open-label randomized controlled feasibility trial to evaluate the feasibility of delivering informational support via an online learning platform to Malaysian parents of children with leukemia or lymphoma. The study will be conducted in two pediatric oncology centres in Kuala Lumpur, Malaysia. Study participants will include adult parents of children who were diagnosed with leukemia or lymphoma in the preceding 3. Block randomization will be used to allocate participants into the intervention or a waitlist-control arm. The intervention group will receive access to e-Hematological Oncology Parent Education (eHOPE), which provides information support for parents in the local Malay language, via an online learning platform. They will also receive usual care, which includes verbal explanations and caregiver education in the course of their child's treatment process. Parents will be able to access multimedia information designed to support them in the care of their sick child, and will need to complete 4 self-paced activities over a period of 8 weeks. The waitlist-control group will receive usual care, and at the end of 8 weeks, will also receive access to eHOPE. The primary outcome of this trial will be the change in caregiving knowledge, whereas secondary outcomes include caregiving self-efficacy and coping self-efficacy. Descriptive data on feasibility will include duration of recruitment to achieve targeted sample size, the drop-out rate of participants and identified barriers to implementation.

Being tested
eHOPE, Usual care
Keywords
Information support, Online learning, Parent, Feasibility, Caregiver education, Self-efficacy, Knowledge
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eHOPEOther

    e-Haematological Oncology Parents Education (eHOPE) consists of caregiving information for parents of children with leukaemia and lymphoma, presented in multimedia format through an online learning platform. The contents are developed in Malay language, encompassing basic information on disease and treatment, medical caregiving, emotional caregiving, appraising information, communication and self-care. Parents will be able to access multimedia information designed to support them in the care of their sick child. There are 4 self-paced activities in eHOPE with the following objectives:

    1. Parents should be able to outline key tasks related to care for their child at home.
    2. Parents should be able to outline strategies to initiate discussions with their child's healthcare providers.
    3. Parents should be able to appraise reliability of information sources.
    4. Parents should be able to identify coping strategies that they can use when faced with stressful situations.

  • Usual careOther

    Face-to-face verbal discussions and caregiver training will be provided as deemed necessary by the clinicians.

Study groups in NCT05455268
Study groupRoleWhat they receive
eHOPEExperimentalParticipants in the intervention group will receive access to e-Hematological Oncology Parent Education (eHOPE) and usual care. Participants will need to complete 4 self-paced activities over a period of 8 weeks. Each activity will be released at 2-weekly intervals.
Receives: Other: eHOPE; Other: Usual care
Usual careActive comparatorParticipants in the waitlist-control group will receive verbal explanations and caregiver education based on clinician's needs assessment in the course of their child's treatment process. At the end of 8-weeks, they will also receive access to eHOPE.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline caregiving knowledge at 8 weeks

    This will be measured by the Hematological Oncology Parent's Education Caregiving Knowledge Questionnaire (HOPE-CKQ), a newly developed and validated 18-item Malay language questionnaire. The scale has a possible score range of 0-18. Higher scores will indicate better knowledge.

    Measured: At baseline and at 8 weeks

  2. Recruitment rate

    This will be calculated as the number of participants recruited and randomized per centre per month.

    Measured: Through study completion, an average of 8 months

  3. Dropout rate

    This will be calculated as the proportion of participants who did not complete the trial over the total number of participants who were recruited and randomized.

    Measured: Through study completion, an average of 8 months

Secondary outcomes (2)

  1. Change from baseline family caregiving self-efficacy at 8 weeks

    Based on scores of the Family Caregiving Activation in Transitions tool, a 10-item 6-point Likert scale with possible scores of 6 to 60. Higher scores indicate better caregiving self-efficacy.

    Measured: At baseline and at 8 weeks.

  2. Change from baseline coping self-efficacy at 8 weeks

    Based on scores of the Coping Self-Efficacy tool, a 26-item 11-point Likert scale with possible scores of 0 to 260. Higher scores denote better coping self-efficacy.

    Measured: At baseline and at 8 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start15 Jul 2022
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

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
Participants for both the intervention and control arms will be recruited simultaneously and allocated using block randomisation to achieve fairly equal numbers of participants in both study sites. At the end of the 8-week intervention period, participants in the waitlist control arm will receive access to the intervention.
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455268
Sponsor's protocol ID
FF-2021-256
Other IDs
NMRR-21-613-58896
Acronym
eHOPE
Status last verified
May 2023
First submitted
27 Jun 2022
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to requirements of the respective ethical committees, individual participant data will not be made available to other researchers. However, reasonable request for deidentified participant data may be considered by the principal investigator on case-to-case basis.

Publications

  • Tan CE, Lau SCD, Latiff ZA, Lee CC, Teh KH, Sidik SM. Information needs of Malaysian parents of children with cancer: A qualitative study. Asia Pac J Oncol Nurs. 2021 Dec 25;9(3):143-152. doi: 10.1016/j.apjon.2021.11.001. eCollection 2022 Mar.

    PubMed 35494095

  • Tan CE, Admodisastro N, Lau SCD, Tan KA, Teh KH, Lee CC, Mohd Sidik S. Development and user evaluation of an online caregiver education resource for Malaysian parents of children with leukemia or lymphoma. Asia Pac J Oncol Nurs. 2023 Dec 20;11(2):100363. doi: 10.1016/j.apjon.2023.100363. eCollection 2024 Feb.

    PubMed 38304227

Questions about this trial

What is this clinical trial studying?

A study testing eHOPE in people with Pediatric Acute Myeloid Leukemia and Pediatric Acute Lymphoid Leukemia, run by Universiti Kebangsaan Malaysia Medical Centre at 2 sites in Malaysia.

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 4 inclusion and 3 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Malaysia. 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?

Change from baseline caregiving knowledge at 8 weeks (time frame: At baseline and at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455268, which also lists 2 linked publications.

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 10 May 2023.

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