Childhood CancerNCT04405531
Effects of TOT on Performance, Independence and Fatigue in Children With Cancer
A study testing task-oriented training (TOT) and conventional occupational therapy (COT) in people with Childhood Cancer and Performance, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explore the effects of Task-Oriented Training (TOT) on occupational performance, activities of daily living and fatigue of children in pediatric oncology clinic. Hypothesis: There is no effect of TOT on occupational performance and satisfaction in children with childhood cancer. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Childhood Cancer, Performance, Functional Independence
- What is being tested?
- task-oriented training (TOT) and conventional occupational therapy (COT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 13 Jan 2020
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being between 6 and 14 years of age;
- receiving inpatient chemotherapy sessions;
- having taken scores higher than 28, 30 and 35 in the mini-mental state exam devised for children of ages 6-8, 9-11 and 12-14, respectively.
Who cannot join
- their disease had recurred, or they were in palliative care;
- they or their parents were not fluent speakers of the Turkish language;
- they were unwilling to take part in the programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Task-Oriented Training on Occupational Performance, Independence, and Fatigue in Children With Childhood Cancer: A Randomized-Controlled Trial
This study aims to explore the effects of Task-Oriented Training (TOT) on occupational performance, activities of daily living and fatigue of children in pediatric oncology clinic.
Hypothesis: There is no effect of TOT on occupational performance and satisfaction in children with childhood cancer. There is no effect of TOT on functional independence in daily living activities in children with childhood cancer. There is no effect of TOT on fatigue levels in children with childhood cancer.
- Conditions
- Childhood Cancer, Performance, Functional Independence, Fatigue
- Being tested
- task-oriented training (TOT), conventional occupational therapy (COT)
- Keywords
- childhood cancer, fatigue, functional independence, occupational performance, task-oriented training
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task-oriented training (TOT)Other
Also called TOT
The study group received a TOT together with a conventional occupational therapy (COT). The study groups received a treatment for 20 sessions at a hospital setting.
conventional occupational therapy (COT)Other
Also called COT
The control group received only a COT program. The control groups received a treatment for 20 sessions at a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| task-oriented training(TOT) | Experimental | The first phase of the TOT, functional activity analysis, was performed for the activities, for which performance problem was determined by Canadian Occupational Performance Measure (COPM) and Functional Independence Measure for Children (WeeFIM). In the second phase, the occupational performance, fatigue and functional independence levels that prevent the realization of the activity were determined by functional activity analysis. These designated occupational performance, fatigue and functional independence levels constitute the task of this study, as we aim to improve children's functionality. In the third phase, various functional activities including these tasks were executed. The TOT was practiced by following the above mentioned steps for each performance area. All the activities were designed for the inpatient settings of children. Receives: Other: task-oriented training (TOT); Other: conventional occupational therapy (COT) |
| conventional occupational therapy (COT) | Experimental | The treatment efficacy determined by the therapist was provided by considering the functional level in order to achieve the desired goal by the participant. The COT included functional activities based on the client-centered principles of the neuro-developmental approach. All the sessions started with relaxation training combined with breathing exercises. At the end of approximately 10 minutes of application time, individualized functional activities were implemented. Receives: Other: conventional occupational therapy (COT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
COPM is a standard measurement used for measuring the occupational performance and satisfaction in children by identifying their problems in performing activities of daily living. Each of the identified activities was asked to be scored between 1 and 10 on the Likert Scale (1: not important; 10: very important). Performance and satisfaction scores were specified by dividing the total scores of performance and satisfaction to the number of activities that the children regard as substantial. A change of two points or more in the score on COPM is considered clinically significant. In the Turkish version of validity and reliability, the internal consistency coefficient of COPM was found to be between 0.9 and 1.
Measured: 6 months
Functional Independence Measure for Children (WeeFIM)
WeeFIM, which is an 18-item and seven-level ordinal scale, measures a child's incoherent performance in basic daily functional skills. It can be used for children with developmental disabilities from 6 months to 21 years. Sub-scales include self-care, sphincter control, movement, transfers, social cognition and communication. The self-care subscale has six items: eating, grooming, bathing, dressing of upper and lower extremities, and the perineal hygiene and adjustment of necessary clothes for the toilet. A scoring scale between 1 (total assistance) to 7 (total independence) was used at this steep. The maximum total score is 126 and the lowest total score is 18, while the maximum scores for self-care, mobility, and cognition are 56, 35, and 35, respectively .
Measured: 6 months
Visual analog scale (VAS)
VAS is a reliable and easily applicable assessment tool that is accepted worldwide in the literature. VAS is used to transform some immeasurable values into quantitative data. It is a scale in which a person marks his / her current emotion level on a vertical line with a 10-cm scale. Every emotion is evaluated in a range from non-existent (i.e. never experiencing that particular sensation or feeling) to highly intensive (i.e. constantly experiencing that particular sensation or feeling). The following expressions were used on the scale: 'Show me your fatigue level on the line, here is no fatigue (score = 0), and there is the wickedest probable fatigue (score = 10)'. This process was repeated for five times as before activity, during-activity, after activity, and morning and evening time intervals. It took less than 1 minute for each application to get completed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jan 2019
- Primary completion3 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP KOLİT, Hacettepe University
- Investigators
- Zeynep Kolit, MSc, Principal investigator, Hacettepe UniversitySedef Şahin, PhD, Study director, Hacettepe UniversityCeren Davutoğlu, MSc, Principal investigator, Hacettepe UniversityMeral Huri, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405531
- Sponsor's protocol ID
- KCTOT
- Status last verified
- May 2020
- First submitted
- 16 May 2020
- Last updated
- 28 May 2020
- 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 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Task-Oriented Training on Occupational Performance, Independence, and Fatigue in Children With Childhood Cancer: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT04405531
- Acronym / sponsor ID
- KCTOT
- Conditions
- Childhood Cancer, Performance, Functional Independence, Fatigue
- Keywords
- childhood cancer, fatigue, functional independence, occupational performance, task-oriented training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 28 May 2020 (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 explore the effects of Task-Oriented Training (TOT) on occupational performance, activities of daily living and fatigue of children in pediatric oncology clinic.
Hypothesis: There is no effect of TOT on occupational performance and satisfaction in children with childhood cancer. There is no effect of TOT on functional independence in daily living activities in children with childhood cancer. There is no effect of TOT on fatigue levels in children with childhood cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| task-oriented training(TOT) | Experimental | Other: task-oriented training (TOT), Other: conventional occupational therapy (COT)The first phase of the TOT, functional activity analysis, was performed for the activities, for which performance problem was determined by Canadian Occupational Performance Measure (COPM) and Functional Independence Measure for Children (WeeFIM). In the second phase, the occupational performance, fatigue and functional independence levels that prevent the realization of the activity were determined by functional activity analysis. These designated occupational performance, fatigue and functional independence levels constitute the task of this study, as we aim to improve children's functionality. In the third phase, various functional activities including these tasks were executed. The TOT was practiced by following the above mentioned steps for each performance area. All the activities were designed for the inpatient settings of children. |
| conventional occupational therapy (COT) | Experimental | Other: conventional occupational therapy (COT)The treatment efficacy determined by the therapist was provided by considering the functional level in order to achieve the desired goal by the participant. The COT included functional activities based on the client-centered principles of the neuro-developmental approach. All the sessions started with relaxation training combined with breathing exercises. At the end of approximately 10 minutes of application time, individualized functional activities were implemented. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being between 6 and 14 years of age;
- receiving inpatient chemotherapy sessions;
- having taken scores higher than 28, 30 and 35 in the mini-mental state exam devised for children of ages 6-8, 9-11 and 12-14, respectively.
Key exclusion criteria (3 listed)
- their disease had recurred, or they were in palliative care;
- they or their parents were not fluent speakers of the Turkish language;
- they were unwilling to take part in the programs.
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 |
|---|---|---|
| task-oriented training (TOT)Also: TOTThe study group received a TOT together with a conventional occupational therapy (COT). The study groups received a treatment for 20 sessions at a hospital setting. | Other | task-oriented training(TOT) |
| conventional occupational therapy (COT)Also: COTThe control group received only a COT program. The control groups received a treatment for 20 sessions at a hospital setting. | Other | conventional occupational therapy (COT), task-oriented training(TOT) |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: 6 months
COPM is a standard measurement used for measuring the occupational performance and satisfaction in children by identifying their problems in performing activities of daily living. Each of the identified activities was asked to be scored between 1 and 10 on the Likert Scale (1: not important; 10: very important). Performance and satisfaction scores were specified by dividing the total scores of performance and satisfaction to the number of activities that the children regard as substantial. A change of two points or more in the score on COPM is considered clinically significant. In the Turkish version of validity and reliability, the internal consistency coefficient of COPM was found to be between 0.9 and 1.
Functional Independence Measure for Children (WeeFIM)
Time frame: 6 months
WeeFIM, which is an 18-item and seven-level ordinal scale, measures a child's incoherent performance in basic daily functional skills. It can be used for children with developmental disabilities from 6 months to 21 years. Sub-scales include self-care, sphincter control, movement, transfers, social cognition and communication. The self-care subscale has six items: eating, grooming, bathing, dressing of upper and lower extremities, and the perineal hygiene and adjustment of necessary clothes for the toilet. A scoring scale between 1 (total assistance) to 7 (total independence) was used at this steep. The maximum total score is 126 and the lowest total score is 18, while the maximum scores for self-care, mobility, and cognition are 56, 35, and 35, respectively .
Visual analog scale (VAS)
Time frame: 6 months
VAS is a reliable and easily applicable assessment tool that is accepted worldwide in the literature. VAS is used to transform some immeasurable values into quantitative data. It is a scale in which a person marks his / her current emotion level on a vertical line with a 10-cm scale. Every emotion is evaluated in a range from non-existent (i.e. never experiencing that particular sensation or feeling) to highly intensive (i.e. constantly experiencing that particular sensation or feeling). The following expressions were used on the scale: 'Show me your fatigue level on the line, here is no fatigue (score = 0), and there is the wickedest probable fatigue (score = 10)'. This process was repeated for five times as before activity, during-activity, after activity, and morning and evening time intervals. It took less than 1 minute for each application to get completed.
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 28 May 2020.
- 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.
Zeynep Kolit, MSc principal investigator
Hacettepe University
Sedef Şahin, PhD study director
Hacettepe University
Ceren Davutoğlu, MSc principal investigator
Hacettepe 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 task-oriented training (TOT) and conventional occupational therapy (COT) in people with Childhood Cancer and Performance, run by Hacettepe 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 3 inclusion and 3 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 28 May 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?
Canadian Occupational Performance Measure (COPM) (time frame: 6 months). 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 28 May 2020.