Psychoeducation Intervention for Caregivers of Children With Cancer

Not Applicable

Completed

• Conditions: Pediatric Cancer
• Interventions: Behavioral: Psychoeducation Intervention

• Registration Number: NCT05783310
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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

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.

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Study Start: 2023-05-22
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

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Exclusion Criteria

• Caregivers of children with other co-morbidities will be excluded from the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychoeducation Intervention	Psychoeducation Intervention	The intervention group will receive six sessions of a psychoeducation intervention delivered face-to-face

Primary Outcome Measures

Name	Time	Method
Anxiety level	Three months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Coping	Baseline, immediately after intervention and three months follow up	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.
Depressive symptoms	Baseline, immediately after intervention and three months follow up	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.
Health-related quality of life	Baseline, immediately after intervention and three months follow up	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.

Trial Locations

Locations (2)

Queen Elizabeth Central Hospital; 🇲🇼 Blantyre, Malawi

Kamuzu Central Hospital; 🇲🇼 Lilongwe, Malawi