Clinical trial NCT05455268: Information Support Using an Online Learning Platform for Malaysian Pediatric Leukemia and Lymphoma Parents
Official title: Feasibility of e-Hematology Oncology Parents Education (eHOPE) for Information Support Among Malaysian Parents of Children With Hematological Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
Collaborators: name: Universiti Putra Malaysia
name: Ministry of Health, Malaysia
First posted: 2022-07-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline caregiving knowledge at 8 weeks
timeFrame: At baseline and at 8 weeks
measure: Recruitment rate
timeFrame: Through study completion, an average of 8 months
measure: Dropout rate
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
measure: Change from baseline family caregiving self-efficacy at 8 weeks
timeFrame: At baseline and at 8 weeks.
measure: Change from baseline coping self-efficacy at 8 weeks
timeFrame: At baseline and at 8 weeks.
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Hospital Tunku Azizah
city: Kuala Lumpur
country: Malaysia
facility: Hospital Tunku Ampuan Besar Tuanku Aishah Rohani Hospital Pakar Kanak-kanak UKM (HPKK)
Study officials:
affiliation: National University of Malaysia
name: Chai Eng Tan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.