Clinical trial NCT05783310: Psychoeducation Intervention for Caregivers of Children With Cancer
Official title: Effectiveness of Psychoeducation Intervention on Reducing Negative Psychological Outcomes and Enhancing Coping of Caregivers of Children With Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: Anxiety
Cancer
Caregivers
Children
Coping
Depressive symptom
Health-related quality of life
Psychoeducation intervention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety level
timeFrame: Baseline
measure: Anxiety level
timeFrame: Post-intervention at six weeks
measure: Anxiety level
timeFrame: Three months post-intervention
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, immediately after intervention and three months follow up
measure: Health-related quality of life
timeFrame: Baseline, immediately after intervention and three months follow up
measure: Coping
timeFrame: Baseline, immediately after intervention and three months follow up
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
Study officials:
affiliation: The Nethersole School of Nursing, Chinese University of Hong Kong
name: William LI
role: STUDY_CHAIR
References: