Pediatric CancerNCT03431155
The Impact of Nursing Interventions Based on Uncertainty In Illness Theory on Care Givers Of Children With Cancer
A study testing Nursing intervention in people with Pediatric Cancer and Nurse's Role, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this Randomised Controlled study was to determine the effect of nursing interventions based on Mishel's Uncertainty in Illness Theory on uncertainty, hopelessness, coping and compliance for care givers' of children with cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer, Nurse's Role
- What is being tested?
- Nursing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2019to 15 Jul 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Care giver of children with cancer who is next to children during the hospital process.
- Children diagnosed and continued to clinical therapy in one of two university hospitals.
- At least have the primary education (5 year education)
- Child get at least one cure chemotherapy/radiotherapy
- Care givers' age must be et least 18 year-old
- Care giver can speak and understand Turkish fluently
Who cannot join
- Care giver with psychiatric disorder
- Child has loss of function due to cancer related operation (amputation, etc)
- Having a child whose treatment of cancer finished
- Having a child whose disease is in remission
- Having a child whose disease relapse
- Having a child who is terminal term
- Having a child who is older than 18 year-old
- Prior to cancer diagnosis, children have a dhronic disease or genetic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Nursing Interventions Based on Uncertainty In Illness Theory on Uncertainty, Hopelessness, Coping And Adaptation for Care Givers Of Children With Cancer
The aim of this Randomised Controlled study was to determine the effect of nursing interventions based on Mishel's Uncertainty in Illness Theory on uncertainty, hopelessness, coping and compliance for care givers' of children with cancer. Sample was 46 (experimental group:23; control group: 23) cara givers of children. Experimental group received nursing interventions (6 modules, 200 minutes nursing education) based on Mishel's Uncertainty in Illness Theory while control group received routine hospital care. Data were collected 3 times: pre test, post test (2 weeks after intervention for experimental group or two weeks after from pretest for control group), and follow up (2 weeks after post tests).
Read the detailed description
Cancer defines a group of diseases that arise from the uncontrolled proliferation and spread of abnormal cells. The prevalence of cancer before the age of 15 years is 110-150 million. Every year, more than 150,000 people in the World are newly diagnosed, and over 10,000 children in America are diagnosed with cancer for the first time. It is reported that 2500-3000 new cases of childhood cancer are expected to be seen in our country, Turkey, annually.
Childhood cancer is a major stressor for family. They are at risk for developing psychosocial problems during the course of disease and its long and stressful treatment. And uncertainty is one of these problems which they live. Uncertainty arises when "the decision maker can not give a definite value to a certain event or situation" or "can not predict the accuracy of the results". Uncertainty refers to the inability to identify, interpret and predict the disease-related condition/event. Uncertainty can have positive or negative affects to child and family according the meaning and coping of uncertainty.
Mishel is the first nurse theorist who mentioned uncertainty in illness in the aspect of nursing as a theory. In her theory, nursing interventions can help care giver to cope with or adapt the uncertainty. Nursing interventions should contain the main domains of such as communication, education, supporting, being reliable health care professional for parents.
In this study, 46 care givers of children with cancer from two different university hospitals in Turkey. They were assigned group by using closed envelops that contain the letter of E(experimental) or C(control). Prior to study, sample size for each group calculated according to effect size (d=0,20), power (.80), alfa error (.05) and it was found 42 for all group. To avoid possible sample problems can be seen during to study (such as do not want to continue the stud etc), sample was improved %10 and sample number were decided 46 care giver in total. During the study while 18 care giver (9 from experimental, 9 from control group) finished the study, we calculated real effect size of our study and it was foun 0.24 and according to it we calculated sample size again and it was 30 in total. So we decided to continiue our study with 46 participants.
Experimental group received nursing intervention according to protocol. It contained 6 modules (total 10 personal education session) that were developed based on Theory and literature. The aim of this intervention was to control/solve the antecedents of uncertainty and to affect appraisal of uncertainty in a positive way so care givers could improve the coping and adaptation of uncertainty. Control group received routine nursing intervention that was given normally for hospitals to avoid bias and ethical problems.
Data was collected using information form (information about participant, parents and children), three scales (Turkish Version of Parents' Perception Uncertainty in Illness Scale: Parent/Child Form, Beck's Hopelessness Scale, Coping and Adaptation Process Scale). Scales validation and reliability studies were made for Turkish population.
- Conditions
- Pediatric Cancer, Nurse's Role
- Being tested
- Nursing intervention
- Keywords
- children, cancer, care giver, uncertainty, nursing intervention, education
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing interventionOther
Nursing Intervention: Protocol and education booklet were developed according to literature and Theory. There were six modules (10 session) which aimed to personal education for every care givers. Every session took 20 minutes and total 200 minutes. First 5 modules finished within 3 days and aafter one week last module completed (to summarize process). Also individual counseling were made.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Nursing intervention Receives: Other: Nursing intervention |
| Control Group | No intervention | - Receive routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less uncertainty
Means of Parents Perceived Uncertainty in Illness Scale: Parent/child From for participants in experimental group will be less.
Measured: At the end of 4 week.
Secondary outcomes (2)
Less hopelessness
Means of Beck Hopelessness Scale for participants in experimental group will be less.
Measured: At the end of 4 week.
More coping and adaptation
Means of Coping and Adaptation Processing Scale for participants in experimental group will be more.
Measured: At the end of 4 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start15 Jan 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
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 Selcuk 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Özkan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431155
- Sponsor's protocol ID
- 2017/44
- Status last verified
- Jun 2020
- First submitted
- 23 Jan 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to share any data of participants.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nursing Interventions Based on Uncertainty In Illness Theory on Uncertainty, Hopelessness, Coping And Adaptation for Care Givers Of Children With Cancer
- ClinicalTrials.gov ID
- NCT03431155
- Acronym / sponsor ID
- 2017/44
- Conditions
- Pediatric Cancer, Nurse's Role
- Keywords
- children, cancer, care giver, uncertainty, nursing intervention, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 13 Feb 2018 (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.
The aim of this Randomised Controlled study was to determine the effect of nursing interventions based on Mishel's Uncertainty in Illness Theory on uncertainty, hopelessness, coping and compliance for care givers' of children with cancer. Sample was 46 (experimental group:23; control group: 23) cara givers of children. Experimental group received nursing interventions (6 modules, 200 minutes nursing education) based on Mishel's Uncertainty in Illness Theory while control group received routine hospital care. Data were collected 3 times: pre test, post test (2 weeks after intervention for experimental group or two weeks after from pretest for control group), and follow up (2 weeks after post tests).
Detailed description
Cancer defines a group of diseases that arise from the uncontrolled proliferation and spread of abnormal cells. The prevalence of cancer before the age of 15 years is 110-150 million. Every year, more than 150,000 people in the World are newly diagnosed, and over 10,000 children in America are diagnosed with cancer for the first time. It is reported that 2500-3000 new cases of childhood cancer are expected to be seen in our country, Turkey, annually.
Childhood cancer is a major stressor for family. They are at risk for developing psychosocial problems during the course of disease and its long and stressful treatment. And uncertainty is one of these problems which they live. Uncertainty arises when "the decision maker can not give a definite value to a certain event or situation" or "can not predict the accuracy of the results". Uncertainty refers to the inability to identify, interpret and predict the disease-related condition/event. Uncertainty can have positive or negative affects to child and family according the meaning and coping of uncertainty.
Mishel is the first nurse theorist who mentioned uncertainty in illness in the aspect of nursing as a theory. In her theory, nursing interventions can help care giver to cope with or adapt the uncertainty. Nursing interventions should contain the main domains of such as communication, education, supporting, being reliable health care professional for parents.
In this study, 46 care givers of children with cancer from two different university hospitals in Turkey. They were assigned group by using closed envelops that contain the letter of E(experimental) or C(control). Prior to study, sample size for each group calculated according to effect size (d=0,20), power (.80), alfa error (.05) and it was found 42 for all group. To avoid possible sample problems can be seen during to study (such as do not want to continue the stud etc), sample was improved %10 and sample number were decided 46 care giver in total. During the study while 18 care giver (9 from experimental, 9 from control group) finished the study, we calculated real effect size of our study and it was foun 0.24 and according to it we calculated sample size again and it was 30 in total. So we decided to continiue our study with 46 participants.
Experimental group received nursing intervention according to protocol. It contained 6 modules (total 10 personal education session) that were developed based on Theory and literature. The aim of this intervention was to control/solve the antecedents of uncertainty and to affect appraisal of uncertainty in a positive way so care givers could improve the coping and adaptation of uncertainty. Control group received routine nursing intervention that was given normally for hospitals to avoid bias and ethical problems.
Data was collected using information form (information about participant, parents and children), three scales (Turkish Version of Parents' Perception Uncertainty in Illness Scale: Parent/Child Form, Beck's Hopelessness Scale, Coping and Adaptation Process Scale). Scales validation and reliability studies were made for Turkish population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Nursing interventionNursing intervention |
| Control Group | No intervention | –- Receive routine nursing care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Care giver of children with cancer who is next to children during the hospital process.
- Children diagnosed and continued to clinical therapy in one of two university hospitals.
- At least have the primary education (5 year education)
- Child get at least one cure chemotherapy/radiotherapy
- Care givers' age must be et least 18 year-old
Key exclusion criteria (8 listed)
- Care giver with psychiatric disorder
- Child has loss of function due to cancer related operation (amputation, etc)
- Having a child whose treatment of cancer finished
- Having a child whose disease is in remission
- Having a child whose disease relapse
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 |
|---|---|---|
| Nursing interventionNursing Intervention: Protocol and education booklet were developed according to literature and Theory. There were six modules (10 session) which aimed to personal education for every care givers. Every session took 20 minutes and total 200 minutes. First 5 modules finished within 3 days and aafter one week last module completed (to summarize process). Also individual counseling were made. | Other | Experimental group |
Primary outcome
Less uncertainty
Time frame: At the end of 4 week.
Means of Parents Perceived Uncertainty in Illness Scale: Parent/child From for participants in experimental group will be less.
2 secondary outcomes
Less hopelessness
Time frame: At the end of 4 week.
More coping and adaptation
Time frame: At the end of 4 week.
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 26 Jun 2020.
- Individual participant dataSharing planned: No. I do not plan to share any data of participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing intervention in people with Pediatric Cancer and Nurse's Role, run by Selcuk 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 6 inclusion and 8 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 26 Jun 2020. 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?
Less uncertainty (time frame: At the end of 4 week.). 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 26 Jun 2020.