Psychoeducation Intervention for Caregivers of Children With Cancer
NCT ID: NCT05783310
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2023-05-22
2023-12-30
Brief Summary
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The study is a two-arm parallel-group single-blind, randomized controlled trial that will be conducted in two hospitals in Malawi.
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Detailed Description
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Objectives of the study
1. To develop a psychoeducation intervention that addresses the needs of caregivers of children with cancer in Malawian culture.
2. To evaluate the effectiveness of the PEI in reducing anxiety and depressive symptoms and enhancing coping and HRQoL among caregivers of children with cancer in Malawi.
Hypotheses of the study
1. Compared with the control group, caregivers in the intervention group will have significantly lower anxiety levels immediately after the intervention, and at 3 months post-intervention.
2. Compared with the control group, caregivers in the intervention group will have significantly fewer depressive symptoms immediately after the intervention, and at 3 months post-intervention.
3. Compared with the control group, caregivers in the intervention group will have significantly better HRQoL, immediately after the intervention, and at 3 months post-intervention.
4. Compared with the control group, caregivers in the intervention group will have significantly better coping skills immediately after the intervention, and at 3 months post-intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Psychoeducation Intervention
The intervention group will receive six sessions of a psychoeducation intervention delivered face-to-face
Psychoeducation Intervention
The participants in the intervention group will receive six sessions of psychoeducation intervention, lasting 60 minutes per session for six weeks. The intervention will be provided face-to-face using lectures and discussions. There will also be sharing of experience by the caregivers of children with cancer and a sharing by a caregiver of a childhood cancer survivor. The group format has been chosen to enable caregivers to offer emotional support to each other. The intervention has four components: cancer education, coping skills training, stress management techniques training, and psychological support. The intervention group will also receive the usual care.
Control group
No psychoeducation intervention will be given
No interventions assigned to this group
Interventions
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Psychoeducation Intervention
The participants in the intervention group will receive six sessions of psychoeducation intervention, lasting 60 minutes per session for six weeks. The intervention will be provided face-to-face using lectures and discussions. There will also be sharing of experience by the caregivers of children with cancer and a sharing by a caregiver of a childhood cancer survivor. The group format has been chosen to enable caregivers to offer emotional support to each other. The intervention has four components: cancer education, coping skills training, stress management techniques training, and psychological support. The intervention group will also receive the usual care.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Lophina Phiri
Principal Investigator
Principal Investigators
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William LI
Role: STUDY_CHAIR
The Nethersole School of Nursing, Chinese University of Hong Kong
Locations
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Queen Elizabeth Central Hospital
Blantyre, , Malawi
Kamuzu Central Hospital
Lilongwe, , Malawi
Countries
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Other Identifiers
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2023.040
Identifier Type: -
Identifier Source: org_study_id
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