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Psychoeducation Intervention for Caregivers of Children With Cancer

The Chinese University of Hong Kong logo

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

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

Trial contacts and locations

2

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Central trial contact

Lophina Phiri, PhD (c)

Data sourced from clinicaltrials.gov

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