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Completed

NCT Number: NCT05455268

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

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.

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Key information

Conditions

Pediatric Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric Acute Lymphoid Leukemia Pediatric Hodgkin Lymphoma Pediatric Non-Hodgkin Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Tunku Ampuan Besar Tuanku Aishah Rohani Hospital Pakar Kanak-kanak UKM (HPKK), Kuala Lumpur, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

eHOPE

Other

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:

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

Usual Care

Other

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

Primary outcomes

  1. Change from baseline caregiving knowledge at 8 weeks

    Time frame: At baseline and 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.

  2. Recruitment rate

    Time frame: Through study completion, an average of 8 months

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

  3. Dropout rate

    Time frame: Through study completion, an average of 8 months

    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.

Secondary outcomes

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

    Time frame: At baseline and 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.

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

    Time frame: At baseline and 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.

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Collaborators

  • Ministry of Health, Malaysia
  • Universiti Putra Malaysia

Registry information

Official study title

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

Acronym: eHOPE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2022
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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