Pediatric CancerNCT05181228
Evaluation of the Impact of a Family-Centered Empowerment Program on Self-Efficacy, Self-Esteem, Depression, Anxiety, Stress Level, and Care Skills in Parents of Children With Oncological Problems
A study testing Web-Based Education Based on Family-Centered Empowerment Model in people with Pediatric Cancer, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to develop a web-based education program based on family centered empowerment model for parents of children with oncological problems and to evaluate the effect of the program on parents' self-efficacy, self-esteem, depression, anxiety, stress level and care abilities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Web-Based Education Based on Family-Centered Empowerment Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2022to 1 May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a parent (mother or father) of a child with a hematology/oncological diagnosis
- At least 1 months have passed since the child was diagnosed
- Being a parent of a child undergoing chemotherapy
- Parent who were literate
- Parents who has Internet at home
- Parents who has computer or mobile phone
- Parents who no barriers to written or verbal communication
- Parents who agree to participate in the study
Who cannot join
- Patients who do not agree to participate in the study,
- Internet not access in the home environment,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating The Effectiveness of A Family-Centered Empowerment Program Applied to Parents of Children With Oncological Problems
This study aims to develop a web-based education program based on family centered empowerment model for parents of children with oncological problems and to evaluate the effect of the program on parents' self-efficacy, self-esteem, depression, anxiety, stress level and care abilities.
Read the detailed description
Cancer, one of the most important health problems of today, affects children as well as adults and the number of children diagnosed with cancer is increasing all over the world. Cancer management is generally a more complex process than other diseases and requires the caregiver family to have knowledge and skills. Because; Parents, who are the most important persons to contribute to the care of children with oncological problems, need to be supported and strengthened not only in the hospital but also in the home environment in order to manage and solve the problems and cope with this situation. One of the methods used in the empowerment of caregivers; is the family-centered empowerment model (FCEM). Model; It consists of four stages: increasing knowledge, self-efficacy and self-esteem, and evaluation. The purpose of this model; to protect the health of the family and their children, to manage the disease and symptoms, to reduce the incidence of acute attacks, to improve the quality of care by improving the quality of life of children and their parents. Because of technological advancements and growth in the number of internet users, web-based education (WBE) has become one of the most popular ways patient and family education. There is research in the literature that illustrates the benefits of web-based treatments in family strengthening.The web-based training content will be prepared based on the Family-Centered Empowerment Model. For ten weeks, parents will receive a web-based training based on the family-centered empowerment model. For the control group, routine patient education and routine hospital follow-ups will be performed by their nurses during the ten weeks follow-up period. The study's sample size; A priori power analysis was used to determine the minimum sample size. The sample size for the intervention and control groups was 38 parents, and the double-sided hypothesis was calculated as n1=n2, the effect size of 0.659, with 5% Type I error and 80% power. Research data; It was collected using the Parent and Child Information Form, the General Self-Efficacy Scale, the Rosenberg Self-Esteem Scale, the Depression Anxiety and Stress Scale, and the Care Ability Scale of Family Caregivers of Cancer Patients. A statistical package program will be used in the analysis of the data. The conformity of the mean scores of the scale to the normal distribution will be evaluated with the coefficients of kurtosis and skewness, and the means will be compared with parametric or nonparametric test techniques. The similarity of the groups in terms of demographic and clinical characteristics will be evaluated with the relevant tests. Cohen's d effect size will be calculated to express the size of the difference between the means.
- Conditions
- Pediatric Cancer
- Being tested
- Web-Based Education Based on Family-Centered Empowerment Model
- Keywords
- Cancer, Care Ability, Family-Centered Empowerment Model, Web-Based Education, Children
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Education Based on Family-Centered Empowerment ModelBehavioural
Parents in the intervention group will receive care for ten weeks using the family-centered empowerment model (FCEM). The first step (two weeks) is to increase knowledge. For this purpose, they will receive web-based training on cancer. The second step (four weeks) is to develop parents' self-efficacy and problem-solving skills. A web-based training and group meeting will be held to share information and experiences on the evaluation and control of the side effects of the treatment and to increase their self-efficacy in care. The third step (three week) was to increase self-esteem through participation in the training. At this stage, each participant will be asked to teach one of the family members responsible for the child's care what they have learned in the last two sessions. In the fourth step (one week), all participants in the intervention group will be evaluated by asking questions about the topics discussed in the second and third sessions and the overall content taught.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Web-based family-centered empowerment program intervention) | Experimental | Intervention group participants will receive the web-based family-centered empowerment intervention for 10 weeks. Receives: Behavioral: Web-Based Education Based on Family-Centered Empowerment Model |
| Control Group | No intervention | No intervention was applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caring Ability Of Family Caregivers Of Patients With Cancer Scale
It was developed by Nemati et al in 2020 to evaluate the care skills of caregivers involved in the care process of cancer patients and the effectiveness of empowerment interventions according to their care needs. Scale; It is a Likert-type scale consisting of 31 items, five sub-dimensions, and scored between 31 and 155. As the scale score increases, the care ability score also increases. The total scale Cronbach's alpha reliability coefficient obtained from the validity and reliability study of the scale is 0.934. The validity and reliability study of the scale in Turkey was carried out by the researcher.
Measured: 8 weeks
General Self-Efficacy Scale
Schwarzer and Jerusalem established the General Self-Efficacy Scale in Germany in 1981. The scale's Cronbach alpha coefficient, which was adapted into Turkish in our country by Aypay (2010), was determined to be.83. The scale, which is used with people aged 12 and up, is a four-point Likert-type scale with ten items that contain statements about how well the person believes himself/herself to deal with problems in general. The score range of the scale theoretically spans between 10 and 40. If the individual achieves a high score on the scale, it suggests that his/her self-efficacy is high.
Measured: 8 weeks
Rosenberg Self-Esteem Scale
It was developed by Morris Rosenberg in 1963 to assess self-esteem. The scale is used in adolescents, adults, and late adult individuals. In the validity and reliability study conducted by Çuhadaroğlu in Turkey in 1986, the validity coefficient was determined as 0.71. The first ten items form the self-esteem subscale and are used to evaluate self-esteem. On the scale, 0-1 points were scored as high self-esteem, 2-4 points as medium self-esteem, and 5-6 points as low self-esteem. A low score in scale scoring means high self-esteem; A high score indicates low self-esteem.
Measured: 8 weeks
Depression Anxiety and Stress Scale
It is used to determine the depression, anxiety and stress levels of parents. Developed by Lovibond and Lovibond (1995), the first version consists of a total of 42 items. Afterwards, Henry and Crawford (2005) converted the scale into a 21-item short form. The Turkish adaptation study of the scale was conducted by Yılmaz et al. (2017) made by The scale consists of 21 items and three sub-dimensions. There are 7 questions each to measure the dimensions of depression, stress and anxiety. Each item in the scale has a 4-point scoring system that corresponds to 0, 1, 2 or 3 points according to the severity of the symptom. A minimum of 0 and a maximum of 21 points can be obtained in each dimension. High scores obtained from the sub-dimensions mean that the individual has intense feelings for the relevant sub-dimension. Cronbach's alpha internal consistency coefficients for depression, anxiety and stress sub-dimensions are .80, .81 and .75, respectively.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start20 May 2022
- Primary completion1 Dec 2022
- Study completion1 May 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 Mersin UniversityThe 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
- The research has a randomized controlled interventional study design. An impartial investigator who is not participating in the study will conduct the randomization. Six alternative combinations with a block size of four (ABAB(1), ABBA(2),...) containing codes A and B will be constructed using the block randomization method. From 1 to 6, combinations will be numbered. By sorting the integers (1-6) via randomizer.org 21 times in a random order, a random assignment sequence will be formed. By drawing lots with coins, it will be established which of the A and B codes is the intervention group and which is the control group. Participants who meet the inclusion criteria will be asked to sign an informed consent form, and their group will be shared with the researcher after the pre-tests (T1) are completed. In the intervention group, participants will get a web-based training based on the family-centered approach.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya AKDENIZ UYSAL, Mersin University
- Investigators
- Rana Yiğit, Professor, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181228
- Sponsor's protocol ID
- DAU_01
- Status last verified
- Jun 2023
- First submitted
- 18 Dec 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Effectiveness of A Family-Centered Empowerment Program Applied to Parents of Children With Oncological Problems
- ClinicalTrials.gov ID
- NCT05181228
- Acronym / sponsor ID
- DAU_01
- Conditions
- Pediatric Cancer
- Keywords
- Cancer, Care Ability, Family-Centered Empowerment Model, Web-Based Education, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Jan 2022 (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 study aims to develop a web-based education program based on family centered empowerment model for parents of children with oncological problems and to evaluate the effect of the program on parents' self-efficacy, self-esteem, depression, anxiety, stress level and care abilities.
Detailed description
Cancer, one of the most important health problems of today, affects children as well as adults and the number of children diagnosed with cancer is increasing all over the world. Cancer management is generally a more complex process than other diseases and requires the caregiver family to have knowledge and skills. Because; Parents, who are the most important persons to contribute to the care of children with oncological problems, need to be supported and strengthened not only in the hospital but also in the home environment in order to manage and solve the problems and cope with this situation. One of the methods used in the empowerment of caregivers; is the family-centered empowerment model (FCEM). Model; It consists of four stages: increasing knowledge, self-efficacy and self-esteem, and evaluation. The purpose of this model; to protect the health of the family and their children, to manage the disease and symptoms, to reduce the incidence of acute attacks, to improve the quality of care by improving the quality of life of children and their parents. Because of technological advancements and growth in the number of internet users, web-based education (WBE) has become one of the most popular ways patient and family education. There is research in the literature that illustrates the benefits of web-based treatments in family strengthening.The web-based training content will be prepared based on the Family-Centered Empowerment Model. For ten weeks, parents will receive a web-based training based on the family-centered empowerment model. For the control group, routine patient education and routine hospital follow-ups will be performed by their nurses during the ten weeks follow-up period. The study's sample size; A priori power analysis was used to determine the minimum sample size. The sample size for the intervention and control groups was 38 parents, and the double-sided hypothesis was calculated as n1=n2, the effect size of 0.659, with 5% Type I error and 80% power. Research data; It was collected using the Parent and Child Information Form, the General Self-Efficacy Scale, the Rosenberg Self-Esteem Scale, the Depression Anxiety and Stress Scale, and the Care Ability Scale of Family Caregivers of Cancer Patients. A statistical package program will be used in the analysis of the data. The conformity of the mean scores of the scale to the normal distribution will be evaluated with the coefficients of kurtosis and skewness, and the means will be compared with parametric or nonparametric test techniques. The similarity of the groups in terms of demographic and clinical characteristics will be evaluated with the relevant tests. Cohen's d effect size will be calculated to express the size of the difference between the means.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research has a randomized controlled interventional study design. An impartial investigator who is not participating in the study will conduct the randomization. Six alternative combinations with a block size of four (ABAB(1), ABBA(2),...) containing codes A and B will be constructed using the block randomization method. From 1 to 6, combinations will be numbered. By sorting the integers (1-6) via randomizer.org 21 times in a random order, a random assignment sequence will be formed. By drawing lots with coins, it will be established which of the A and B codes is the intervention group and which is the control group. Participants who meet the inclusion criteria will be asked to sign an informed consent form, and their group will be shared with the researcher after the pre-tests (T1) are completed. In the intervention group, participants will get a web-based training based on the family-centered approach.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Web-based family-centered empowerment program intervention) | Experimental | Behavioral: Web-Based Education Based on Family-Centered Empowerment ModelIntervention group participants will receive the web-based family-centered empowerment intervention for 10 weeks. |
| Control Group | No intervention | –No intervention was applied to the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Being a parent (mother or father) of a child with a hematology/oncological diagnosis
- At least 1 months have passed since the child was diagnosed
- Being a parent of a child undergoing chemotherapy
- Parent who were literate
- Parents who has Internet at home
Key exclusion criteria (2 listed)
- Patients who do not agree to participate in the study,
- Internet not access in the home environment,
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 |
|---|---|---|
| Web-Based Education Based on Family-Centered Empowerment ModelParents in the intervention group will receive care for ten weeks using the family-centered empowerment model (FCEM). The first step (two weeks) is to increase knowledge. For this purpose, they will receive web-based training on cancer. The second step (four weeks) is to develop parents' self-efficacy and problem-solving skills. A web-based training and group meeting will be held to share information and experiences on the evaluation and control of the side effects of the treatment and to increase their self-efficacy in care. The third step (three week) was to increase self-esteem through participation in the training. At this stage, each participant will be asked to teach one of the family members responsible for the child's care what they have learned in the last two sessions. In the fourth step (one week), all participants in the intervention group will be evaluated by asking questions about the topics discussed in the second and third sessions and the overall content taught. | Behavioural | Intervention Group (Web-based family-centered empowerment program intervention) |
Primary outcome
Caring Ability Of Family Caregivers Of Patients With Cancer Scale
Time frame: 8 weeks
It was developed by Nemati et al in 2020 to evaluate the care skills of caregivers involved in the care process of cancer patients and the effectiveness of empowerment interventions according to their care needs. Scale; It is a Likert-type scale consisting of 31 items, five sub-dimensions, and scored between 31 and 155. As the scale score increases, the care ability score also increases. The total scale Cronbach's alpha reliability coefficient obtained from the validity and reliability study of the scale is 0.934. The validity and reliability study of the scale in Turkey was carried out by the researcher.
General Self-Efficacy Scale
Time frame: 8 weeks
Schwarzer and Jerusalem established the General Self-Efficacy Scale in Germany in 1981. The scale's Cronbach alpha coefficient, which was adapted into Turkish in our country by Aypay (2010), was determined to be.83. The scale, which is used with people aged 12 and up, is a four-point Likert-type scale with ten items that contain statements about how well the person believes himself/herself to deal with problems in general. The score range of the scale theoretically spans between 10 and 40. If the individual achieves a high score on the scale, it suggests that his/her self-efficacy is high.
Rosenberg Self-Esteem Scale
Time frame: 8 weeks
It was developed by Morris Rosenberg in 1963 to assess self-esteem. The scale is used in adolescents, adults, and late adult individuals. In the validity and reliability study conducted by Çuhadaroğlu in Turkey in 1986, the validity coefficient was determined as 0.71. The first ten items form the self-esteem subscale and are used to evaluate self-esteem. On the scale, 0-1 points were scored as high self-esteem, 2-4 points as medium self-esteem, and 5-6 points as low self-esteem. A low score in scale scoring means high self-esteem; A high score indicates low self-esteem.
Depression Anxiety and Stress Scale
Time frame: 8 weeks
It is used to determine the depression, anxiety and stress levels of parents. Developed by Lovibond and Lovibond (1995), the first version consists of a total of 42 items. Afterwards, Henry and Crawford (2005) converted the scale into a 21-item short form. The Turkish adaptation study of the scale was conducted by Yılmaz et al. (2017) made by The scale consists of 21 items and three sub-dimensions. There are 7 questions each to measure the dimensions of depression, stress and anxiety. Each item in the scale has a 4-point scoring system that corresponds to 0, 1, 2 or 3 points according to the severity of the symptom. A minimum of 0 and a maximum of 21 points can be obtained in each dimension. High scores obtained from the sub-dimensions mean that the individual has intense feelings for the relevant sub-dimension. Cronbach's alpha internal consistency coefficients for depression, anxiety and stress sub-dimensions are .80, .81 and .75, respectively.
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 13 Jun 2023.
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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.
Rana Yiğit, Professor study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Education Based on Family-Centered Empowerment Model in people with Pediatric Cancer, run by Mersin University at 1 site in Turkey (Türkiye).
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 8 inclusion and 2 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 13 Jun 2023. 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 Turkey (Türkiye). 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?
Caring Ability Of Family Caregivers Of Patients With Cancer Scale (time frame: 8 weeks). The study lists 4 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 13 Jun 2023.