Psychoeducation Intervention for Caregivers of Children With Cancer

Study Overview
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Brief Summary
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This randomized controlled trial aims to evaluate the effectiveness of the psychoeducation intervention on anxiety, depressive symptoms, coping, and HRQoL in caregivers of children with cancer. The study is a two-arm parallel-group single-blind, randomized controlled trial that will be conducted in two hospitals in Malawi.

Detailed Description
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Aim of the study To develop and implement psychoeducation intervention that meet the need of caregivers of children with cancer in Malawi. Objectives of the study To develop a psychoeducation intervention that addresses the needs of caregivers of children with cancer in Malawian culture. 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 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. 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. 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. 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.

Official Title
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Effectiveness of Psychoeducation Intervention on Reducing Negative Psychological Outcomes and Enhancing Coping of Caregivers of Children With Cancer: A Randomized Controlled Trial

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Behavioral: Psychoeducation Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caregivers will be included if the child is within the one-year post-cancer diagnosis and on treatment, the primary carer of the child, the child is aged ≤ 15 years, caregivers are above 18 years, and caregivers must have a score of more than five on GAD-7 score. A score of 5 is the cut-off point for anxiety in this questionnaire. Exclusion Criteria: Caregivers of children with other co-morbidities will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducation Intervention<br>The intervention group will receive six sessions of a psychoeducation intervention delivered face-to-face | Behavioral: Psychoeducation Intervention<br>* 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.<br>|
| No Intervention: Control group<br>No psychoeducation intervention will be given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level | Anxiety will be measured using the General Anxiety Disorder questionnaire (GAD-7) GAD-7 is a 7-item scale that assesses anxiety symptoms on a 4-point scale (0=not at all to 3=nearly every day). The final score is determined by summing the scores for the seven items. Scores 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively. | Baseline | 
| Anxiety level | Anxiety will be measured using the General Anxiety Disorder questionnaire (GAD-7) GAD-7 is a 7-item scale that assesses anxiety symptoms on a 4-point scale (0=not at all to 3=nearly every day). The final score is determined by summing the scores for the seven items. Scores 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively. | Post-intervention at six weeks | 
| Anxiety level | Anxiety will be measured using the General Anxiety Disorder questionnaire (GAD-7) GAD-7 is a 7-item scale that assesses anxiety symptoms on a 4-point scale (0=not at all to 3=nearly every day). The final score is determined by summing the scores for the seven items. Scores 5, 10, and 15 represent the cut-off points for mild, moderate, and severe anxiety, respectively. | Three months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9).The PHQ-9 is a 9-item scale that measures depressive symptoms on a 4-point scale (0=not at all to 3=nearly every day), and the final score is obtained by summing the scores for the nine items. The scores 5, 10, 15, and 20 represent cut-off points for mild depression, moderate depression, moderately severe depression, and severe depression. | Baseline, immediately after intervention and three months follow up | 
| Health-related quality of life | The HRQoL will be measured using the Medical Outcomes Study (MOS) 12-item short-form health survey (SF-12) questionnaire. The SF-12 contains a subset of the SF-36 covering the eight dimensions of the HRQoL in two domains of physical health component (PHC) and mental health component (MHC). The final score is calculated by transforming each scale into 0-100; the higher the mean score, the better the HRQoL. | Baseline, immediately after intervention and three months follow up | 
| Coping | The coping will be measured by Brief Coping Orientation to Problems Experienced (COPE). Brief-COPE is a 28-self-reporting item scale for assessing an individual's ways of coping with stress. The tool is evaluated on the Likert scale of 1 to 4 (1 = I have not been doing it, and 4 = I have been doing it). Brief COPE has 14 subscales: active coping, use of information support, positive reframing, planning, emotional support, venting, humor, acceptance, religion, self-blame, denial, substance use, and behavioral disengagement. The total score is obtained by summing up the individual subscale; the higher score indicates high utilization of coping style in that particular subscale. | Baseline, immediately after intervention and three months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Cancer, Caregivers, Children, Coping, Depressive symptom, Health-related quality of life, Psychoeducation intervention