Psychoeducation Intervention for Caregivers of Children With Cancer

The Chinese University of Hong Kong

Status: Completed

Conditions: Pediatric Cancer

Treatments: Behavioral: Psychoeducation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05783310

2023.040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Psychoeducation Intervention

Experimental group

Description:

The intervention group will receive six sessions of a psychoeducation intervention delivered face-to-face

Treatment:

Behavioral: Psychoeducation Intervention

Control group

No Intervention group

Description:

No psychoeducation intervention will be given