Psychoeducation Intervention for Caregivers of Children With Cancer

NCT05783310 | Completed

• 1 other identifier: 2023.040
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Cancer

Keywords

Anxiety; Cancer; Caregivers; Children; Coping; Depressive symptom; Health-related quality of life; Psychoeducation intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Depressive symptoms

  Baseline, immediately after intervention and three months follow up

• Health-related quality of life

  Baseline, immediately after intervention and three months follow up

• Coping

  Baseline, immediately after intervention and three months follow up

Study Arms (2)

Psychoeducation Intervention

EXPERIMENTAL

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

Behavioral: Psychoeducation Intervention

Control group

NO INTERVENTION

No psychoeducation intervention will be given

Interventions

Psychoeducation Intervention BEHAVIORAL

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.

Psychoeducation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Kamuzu Central Hospital

Lilongwe, Malawi

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• William LI

  The Nethersole School of Nursing, Chinese University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data collection research assistant will be blinded to the participant's allocation group to avoid the risk of assessor bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel assignment

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 24, 2023
• Study Start: May 22, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

MA (2)