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

NCT05455268 | Completed

• 2 other identifiers: FF-2021-256NMRR-21-613-58896
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Pediatric Acute Myeloid Leukemia; Pediatric Acute Lymphoid Leukemia; Pediatric Non-Hodgkin Lymphoma; Pediatric Hodgkin Lymphoma

Keywords

Information support; Online learning; Parent; Feasibility; Caregiver education; Self-efficacy; Knowledge

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change from baseline family caregiving self-efficacy at 8 weeks

  At baseline and at 8 weeks.

• Change from baseline coping self-efficacy at 8 weeks

  At baseline and at 8 weeks.

Study Arms (2)

eHOPE

EXPERIMENTAL

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; Other: Usual care

Usual care

ACTIVE COMPARATOR

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

Interventions

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: 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.

eHOPE

Usual care OTHER

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

Usual care; eHOPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead
• Universiti Putra Malaysia: collaborator
• Ministry of Health, Malaysia: collaborator

Study Sites (2)

Hospital Tunku Azizah

Kuala Lumpur, 50300, Malaysia

Location

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

Kuala Lumpur, 56000, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 35494095 BACKGROUND

• 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.

  PMID: 38304227 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chai Eng Tan

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 13, 2022
• Study Start: July 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)