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Completed

NCT Number: NCT04405531

Effects of TOT on Performance, Independence and Fatigue in Children With Cancer

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.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

task-oriented training (TOT)

Other

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.

Other names: TOT

conventional occupational therapy (COT)

Other

The control group received only a COT program. The control groups received a treatment for 20 sessions at a hospital setting.

Other names: COT

Primary outcomes

  1. 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.

  2. 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 .

  3. 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effectiveness of Task-Oriented Training on Occupational Performance, Independence, and Fatigue in Children With Childhood Cancer: A Randomized-Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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