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

NCT ID: NCT04405531

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-01-13

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

task-oriented training(TOT)

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.

Group Type: EXPERIMENTAL

task-oriented training (TOT)

Intervention Type: 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.

conventional occupational therapy (COT)

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

conventional occupational therapy (COT)

Intervention Type: OTHER

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

Interventions

task-oriented training (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.

Intervention Type: OTHER

conventional occupational therapy (COT)

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

Intervention Type: OTHER

Other Intervention Names

TOT; COT

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

ZEYNEP KOLİT

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Kolit, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Sedef Şahin, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Ceren Davutoğlu, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Meral Huri, PhD

Role: STUDY_CHAIR

Hacettepe University

Locations

Hacettepe University

Ankara, Sıhhiye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KCTOT

Identifier Type: -

Identifier Source: org_study_id