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NCT Number: NCT05783310

Psychoeducation Intervention for Caregivers of Children With Cancer

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.

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Key information

Conditions

Pediatric Cancer Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Central Hospital, Blantyre, Malawi

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About this study

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

  • To develop a psychoeducation intervention that addresses the needs of caregivers of children with cancer in Malawian culture.
  • 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

  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Anxiety level

    Time frame: Baseline

    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.

  2. Anxiety level

    Time frame: Post-intervention at six weeks

    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.

  3. Anxiety level

    Time frame: 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 outcomes

  1. Depressive symptoms

    Time frame: 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.

  2. Health-related quality of life

    Time frame: 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.

  3. Coping

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effectiveness of Psychoeducation Intervention on Reducing Negative Psychological Outcomes and Enhancing Coping of Caregivers of Children With Cancer: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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