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| ID | Type | Description | Link |
|---|---|---|---|
| NMRR-21-613-58896 | Other Identifier | MREC Ministry of Health Malaysia |
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| Name | Class |
|---|---|
| Universiti Putra Malaysia | OTHER |
| Ministry of Health, Malaysia | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chai Eng Tan | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Tunku Azizah | Kuala Lumpur | 50300 | Malaysia | |||
| Hospital Tunku Ampuan Besar Tuanku Aishah Rohani Hospital Pakar Kanak-kanak UKM (HPKK) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35494095 | Background | 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. | |
| 38304227 | Derived | 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. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2022 | Jul 7, 2022 |
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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.
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| Usual care | Other | Face-to-face verbal discussions and caregiver training will be provided as deemed necessary by the clinicians. |
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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. |
| Kuala Lumpur |
| 56000 |
| Malaysia |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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