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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Hodgkin Lymphoma; Pediatric Acute Myeloid Leukemia; Pediatric Acute Lymphoid Leukemia; Pediatric Non-Hodgkin Lymphoma
• Intervention / Treatment: Other: eHOPE; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50300
    • Hospital Tunku Azizah
  • Kuala Lumpur, Malaysia, 56000
    • Hospital Tunku Ampuan Besar Tuanku Aishah Rohani Hospital Pakar Kanak-kanak UKM (HPKK)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eHOPE; Participants 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.	Other: eHOPE; 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.; Other: Usual care; Face-to-face verbal discussions and caregiver training will be provided as deemed necessary by the clinicians.
Active Comparator: Usual care; Participants 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.	Other: Usual care; Face-to-face verbal discussions and caregiver training will be provided as deemed necessary by the clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and at 8 weeks
Recruitment rate	This will be calculated as the number of participants recruited and randomized per centre per month.	Through study completion, an average of 8 months
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.	Through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and at 8 weeks.
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.	At baseline and at 8 weeks.

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Collaborators: Universiti Putra Malaysia; Ministry of Health, Malaysia
• Investigators: Principal Investigator: Chai Eng Tan, National University of Malaysia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Feasibility; Self-efficacy; Online learning; Parent; Knowledge; Information support; Caregiver education
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: FF-2021-256; NMRR-21-613-58896 (Other Identifier: MREC Ministry of Health Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No