Pediatric CancerNCT05783310
Psychoeducation Intervention for Caregivers of Children With Cancer
A study testing Psychoeducation Intervention in people with Pediatric Cancer, run by Chinese University of Hong Kong at 2 sites in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Psychoeducation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesMalawi
- Study dates
- 22 May 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Caregivers of children with other co-morbidities will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Malawi2 sites
Queen Elizabeth Central Hospital
Blantyre
Kamuzu Central Hospital
Lilongwe
About this study
Official title: Effectiveness of Psychoeducation Intervention on Reducing Negative Psychological Outcomes and Enhancing Coping of Caregivers of Children With Cancer: A Randomized Controlled Trial
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.
Read the 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
- 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.
- Conditions
- Pediatric Cancer
- Being tested
- Psychoeducation Intervention
- Keywords
- Anxiety, Cancer, Caregivers, Children, Coping, Depressive symptom, Health-related quality of life, Psychoeducation intervention
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation Intervention | Experimental | The intervention group will receive six sessions of a psychoeducation intervention delivered face-to-face Receives: Behavioral: Psychoeducation Intervention |
| Control group | No intervention | No psychoeducation intervention will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Three months post-intervention
Secondary outcomes (3)
Depressive symptoms
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.
Measured: Baseline, immediately after intervention and three months follow up
Health-related quality of life
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.
Measured: Baseline, immediately after intervention and three months follow up
Coping
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.
Measured: Baseline, immediately after intervention and three months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start22 May 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lophina Phiri, Chinese University of Hong Kong
- Investigators
- William LI, Study chair, The Nethersole School of Nursing, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783310
- Sponsor's protocol ID
- 2023.040
- Status last verified
- Feb 2024
- First submitted
- 2 Mar 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Psychoeducation Intervention on Reducing Negative Psychological Outcomes and Enhancing Coping of Caregivers of Children With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05783310
- Acronym / sponsor ID
- 2023.040
- Conditions
- Pediatric Cancer
- Keywords
- Anxiety, Cancer, Caregivers, Children, Coping, Depressive symptom, Health-related quality of life, Psychoeducation intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Intervention | Experimental | Behavioral: Psychoeducation InterventionThe intervention group will receive six sessions of a psychoeducation intervention delivered face-to-face |
| Control group | No intervention | –No psychoeducation intervention will be given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Caregivers of children with other co-morbidities will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation InterventionThe 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. | Behavioural | Psychoeducation Intervention |
Primary outcome
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.
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.
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.
3 secondary outcomes
Depressive symptoms
Time frame: Baseline, immediately after intervention and three months follow up
Health-related quality of life
Time frame: Baseline, immediately after intervention and three months follow up
Coping
Time frame: Baseline, immediately after intervention and three months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William LI study chair
The Nethersole School of Nursing, Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation Intervention in people with Pediatric Cancer, run by Chinese University of Hong Kong at 2 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.