Psychologic ResiliencePhase 3NCT07878078
Influence of Art Workshops and Cognitive Support for Families of Children With Cancer.
A Phase 3 study testing Art Workshops and Cognitive Support Sessions. in people with Psychologic Resilience, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial summary
This clinical trial aims to evaluate the effectiveness of combining art workshops and knowledge-based lectures in enhancing psychological resilience among parents of children with cancer, with the primary outcome focused on whether the integrated program improves resilience among parents of children with cancer and… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Psychologic Resilience
- What is being tested?
- Art Workshops and Cognitive Support Sessions.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Apr 2026to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Parents (mother or father) of children with cancer currently undergoing treatment.
- Age between 20 and 60 years.
- Willingness to cooperate and participate in the program.
- Caregiver must be one of the parents
Who cannot join
- Cases with major depressive disorder, psychotic disorders (e.g., schizophrenia), bipolar disorder, recurrent panic disorder, or severe phobias.
- Parents unable to commit to attending sessions or following the program schedule.
- Cases with cognitive impairments or inability to communicate verbally.
- Families whose child is receiving palliative care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Children's cancer hospital 57357
Cairo, Cairo Governorate, 11617
Dina Elgalaly, 2025351500, delgalaly@gmail.com
About this study
Official title: The Impact of Art Workshops and Cognitive Support on Enhancing Psychological Resilience Among Families of Children With Cancer.
This clinical trial aims to evaluate the effectiveness of combining art workshops and knowledge-based lectures in enhancing psychological resilience among parents of children with cancer, with the primary outcome focused on whether the integrated program improves resilience among parents of children with cancer and the secondary outcome examining whether the type of cancer (solid vs. hematological) influences results; participants will engage in a structured 3-month program consisting of 12 sessions delivered to a fixed group, each lasting two hours.
Read the detailed description
The goal of this clinical trial is to evaluate the effectiveness of combining art workshops and knowledge-based lectures in enhancing psychological resilience among parents of children with cancer.
Primary outcome: Does combining art workshops and knowledge-based lectures enhance psychological resilience among parents of children with cancer? Secondary outcome: Is the type of cancer either solid or hematological influences the effects of the resilience program? The sample will be selected randomly from parents of children with cancer.
Total sample size: 64 participants, divided into two groups:
Experimental group: 32 participants receiving the combined program (art workshops + knowledge lectures).
Control group: 32 participants receiving standard care without the intervention.
Allocation will be conducted using Block Stratified Randomization software version.
- Conditions
- Psychologic Resilience
- Being tested
- Art Workshops and Cognitive Support Sessions.
- Keywords
- parents of children with cancer, psychological resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Workshops and Cognitive Support Sessions.Behavioural
A structured behavioral program designed for parents of children with cancer. The intervention consists of 12 group sessions delivered over 3 months, each lasting 2 hours. Sessions combine guided art activities and cognitive support lectures aimed at enhancing psychological resilience.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 32 participants will be exposed to the 12-session program over 3 months, each session lasting 2 hours with pre- and post program assessments. Receives: Behavioral: Art Workshops and Cognitive Support Sessions. |
| Control | No intervention | 32 participants will only receive pre- and post assessments without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Psychological Resilience Scale by Connor and Davidson (Davidson-Connor), adapted by Singh and Nan Yu (2010) and translated to Arabic by Ahmed Elbaiomy.
The Connor-Davidson Resilience Scale (CD-RISC) defines resilience through several dimensions, each capturing a different psychological strength: hardiness, optimism, resourcefulness, and purpose/goal. Together, they measure how individuals adapt and thrive under stress.
The scale consists of 25 items. Responses are given from the following options:
- Very high degree
- High degree
- Moderate degree
- Low degree
- Very low degree Each item is scored from 5 points down to 1 point. The highest possible score is 125 (25 items × 5 points). The lowest possible score is 25 (25 items × 1 point). High scores indicate strong resilience, while low scores indicate weak resilience.
Measured: From enrollment to the end of the program at 3 months (total of 12 sessions)
Secondary outcomes (1)
The impact of art workshops and cognitive lectures for parents of children with solid tumors vs. liquid tumors by comparing the level of psychological resilience and coping ability in those parents.
Using the Connor-Davidson Resilience Scale (CD-RISC) which defines resilience through several dimensions, each capturing a different psychological strength: hardiness, optimism, resourcefulness, and purpose/goal. Together, they measure how individuals adapt and thrive under stress.
The scale consists of 25 items. Responses are given from the following options:
Very high degree High degree Moderate degree Low degree Very low degree Each item is scored from 5 points down to 1 point. The highest possible score is 125 (25 items × 5 points). The lowest possible score is 25 (25 items × 1 point). High scores indicate strong resilience, while low scores indicate weak resilience.
Results from parents of children with solid tumors and liquid tumors are compared to see the if there are any differences in the impact of these art workshops and cognitive lectures between the two populations.
Measured: From enrollment to the end of program at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start27 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychologic ResilienceStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research sample will be 64 caregivers of children with cancer during the treatment period, aged 20-60 years, randomly assigned (Block Stratified Randomization v6) into 32 experimental and 32 control participants. The researchers will use an experimental design with pre- and post-tests for both the experimental and the control group. The control group will receive assessments without intervention. The experimental group will participate in the integrated program for three months. The Psychological Resilience Scale (Connor \& Davidson, 2003), adapted by Singh \& Nan Yu (2010) and translated by Ahmed El-Bayoumi, will be used.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amira Kaseem Elsahhar, Principal investigator, Children's cancer hospital 57357Heba Mohamed Atef, Principal investigator, Children's cancer hospital 57357
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878078
- Sponsor's protocol ID
- N-0067-005-026
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Art Workshops and Cognitive Support on Enhancing Psychological Resilience Among Families of Children With Cancer.
- ClinicalTrials.gov ID
- NCT07878078
- Acronym / sponsor ID
- N-0067-005-026
- Conditions
- Psychologic Resilience
- Keywords
- parents of children with cancer, psychological resilience
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Oct 2026 (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 clinical trial aims to evaluate the effectiveness of combining art workshops and knowledge-based lectures in enhancing psychological resilience among parents of children with cancer, with the primary outcome focused on whether the integrated program improves resilience among parents of children with cancer and the secondary outcome examining whether the type of cancer (solid vs. hematological) influences results; participants will engage in a structured 3-month program consisting of 12 sessions delivered to a fixed group, each lasting two hours.
Detailed description
The goal of this clinical trial is to evaluate the effectiveness of combining art workshops and knowledge-based lectures in enhancing psychological resilience among parents of children with cancer.
Primary outcome: Does combining art workshops and knowledge-based lectures enhance psychological resilience among parents of children with cancer? Secondary outcome: Is the type of cancer either solid or hematological influences the effects of the resilience program? The sample will be selected randomly from parents of children with cancer.
Total sample size: 64 participants, divided into two groups:
Experimental group: 32 participants receiving the combined program (art workshops + knowledge lectures).
Control group: 32 participants receiving standard care without the intervention.
Allocation will be conducted using Block Stratified Randomization software version.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research sample will be 64 caregivers of children with cancer during the treatment period, aged 20-60 years, randomly assigned (Block Stratified Randomization v6) into 32 experimental and 32 control participants. The researchers will use an experimental design with pre- and post-tests for both the experimental and the control group. The control group will receive assessments without intervention. The experimental group will participate in the integrated program for three months. The Psychological Resilience Scale (Connor \& Davidson, 2003), adapted by Singh \& Nan Yu (2010) and translated by Ahmed El-Bayoumi, will be used.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Art Workshops and Cognitive Support Sessions.32 participants will be exposed to the 12-session program over 3 months, each session lasting 2 hours with pre- and post program assessments. |
| Control | No intervention | –32 participants will only receive pre- and post assessments without intervention. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parents (mother or father) of children with cancer currently undergoing treatment.
- Age between 20 and 60 years.
- Willingness to cooperate and participate in the program.
- Caregiver must be one of the parents
Key exclusion criteria (4 listed)
- Cases with major depressive disorder, psychotic disorders (e.g., schizophrenia), bipolar disorder, recurrent panic disorder, or severe phobias.
- Parents unable to commit to attending sessions or following the program schedule.
- Cases with cognitive impairments or inability to communicate verbally.
- Families whose child is receiving palliative care.
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 |
|---|---|---|
| Art Workshops and Cognitive Support Sessions.A structured behavioral program designed for parents of children with cancer. The intervention consists of 12 group sessions delivered over 3 months, each lasting 2 hours. Sessions combine guided art activities and cognitive support lectures aimed at enhancing psychological resilience. | Behavioural | Experimental |
Primary outcome
The Psychological Resilience Scale by Connor and Davidson (Davidson-Connor), adapted by Singh and Nan Yu (2010) and translated to Arabic by Ahmed Elbaiomy.
Time frame: From enrollment to the end of the program at 3 months (total of 12 sessions)
The Connor-Davidson Resilience Scale (CD-RISC) defines resilience through several dimensions, each capturing a different psychological strength: hardiness, optimism, resourcefulness, and purpose/goal. Together, they measure how individuals adapt and thrive under stress. The scale consists of 25 items. Responses are given from the following options: * Very high degree * High degree * Moderate degree * Low degree * Very low degree Each item is scored from 5 points down to 1 point. The highest possible score is 125 (25 items × 5 points). The lowest possible score is 25 (25 items × 1 point). High scores indicate strong resilience, while low scores indicate weak resilience.
1 secondary outcome
The impact of art workshops and cognitive lectures for parents of children with solid tumors vs. liquid tumors by comparing the level of psychological resilience and coping ability in those parents.
Time frame: From enrollment to the end of program at 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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.
Amira Kaseem Elsahhar principal investigator
Children's cancer hospital 57357
Heba Mohamed Atef principal investigator
Children's cancer hospital 57357
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Art Workshops and Cognitive Support Sessions. in people with Psychologic Resilience, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Ashraf Abdellatif (+201141083507, nancy.ashraf@57357.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Psychological Resilience Scale by Connor and Davidson (Davidson-Connor), adapted by Singh and Nan Yu (2010) and translated to Arabic by Ahmed Elbaiomy. (time frame: From enrollment to the end of the program at 3 months (total of 12 sessions)). 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 16 Oct 2026.