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

Pediatric Acute Myeloid Leukemia Clinical Trial

— eHOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455268
• Other study ID #: FF-2021-256
• Secondary ID: NMRR-21-613-5889
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Pediatric Acute Lymphoid Leukemia
• Pediatric Acute Myeloid Leukemia
• Pediatric Hodgkin Lymphoma
• Pediatric Non-Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Malaysia	Hospital Tunku Ampuan Besar Tuanku Aishah Rohani Hospital Pakar Kanak-kanak UKM (HPKK)	Kuala Lumpur
Malaysia	Hospital Tunku Azizah	Kuala Lumpur

Sponsors (3)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre	Ministry of Health, Malaysia, Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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.