Clinical trial NCT03586401: Creating a Decision Support System for the Corporate Management of Physical Therapy
Official title: Creating a Decision Support System for the Corporate Management of Physical Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Brain Tumor
Physical Activity
Physical Disability
Keywords: Children who have been treated for cancer
Qualification of health
Physical insolvency
Late toxic effects
Physical therapy
Physical activity
Systems for decision making support
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be attended by 1000 families with children who have completed treatment for cancer on at least 6 months before the start of the trial and undergo rehabilitation courses at the Medical-Rehabilitation Research Center "Russkoe pole" at least twice a year.

Brief summary: The purpose of this study is to create a software product on the basis of the support technologies for making decisions for the collaboration of the different specialists, the family and the patient himself in the process of physical therapy of children treated for cancer. The basic model of the technology is a qualification model of the state of health and physical limitations, based on data from a survey of 1,000 children treated for cancer. The software product is supposed to be created on the basis of the Splunk system, the key link is a personal office with a two-way login system: for specialists and for patients. The patient introduces the results of self-examination, monitoring and additional surveys in real time, specialists - additional recommendations. To assess the effectiveness of the collaboration based on the software product, a long-term follow-up (at least 3 years) is planned for the participants of the study with repeated examinations at the Medical-Rehabilitation Scientific Center "Russe pole" at least twice a year.

Condition or disease Hemoblastosis Solid brain tumors The condition after hematopoietic stem cell transplantation

Detailed description: Detailed Description:

The treatment of the oncological diseases are significantly destroyed the physical health of the patients, negatively affecting the cardiovascular, respiratory and musculoskeletal systems. In the absence of a targeted rehabilitation measures, the toxic effect of the treatment increases with time and leads to the development of disabling diseases. Physical therapy and motor activity are recognized as the most effective for the maximum rehabilitation of people who have been through the oncological disease and the prevention of chronic diseases and repeated tumors. Motor activity should be regular, controlled, adapted to the needs and capabilities of a particular person. The main role in maintaining of the level and quality of motor activity is assigned to the patient and his inner circle. Specialists are assigned the role of consultants and supervisors.

The methods, means and intensity of the motor loads should be selected on the basis of a detailed analysis of physical health and existing limitations. To do this, it is proposed to create a qualification model of physical health, in which many indicators will be reduced to a limited number of variables: the response of the cardiovascular and respiratory systems to stress, vegetative and neuromuscular physical activity, the state of motor functions and motor skills, the general resistance to physical loads, etc. To create a model, mathematical modeling methods will be applied.

To create personal program of physical activity, the rules for the selection and adaptation of the methods and means and a database of methods and means that provide a choice considering goals and existing limitations will be developed. The interactive forms for self-analysis and monitoring of the patient's motor activity, available for viewing by specialists will be developed.

The software product, within which the interaction between patients and specialists will be realized, is supposed to be created in the Splunk system. The system allows to search both the real-time data and the archived data, based on the results of the search Splunk gives you the opportunity to: analyze the results with the visualization tools, generate reports and warnings, create a monitoring and notification systems in real time. These can be expanded - you can create new applications using the specialized development platform that comes with Splunk. The study will be attended by at least 1000 patients and their families who have concluded an agreement with the Medical-Rehabilitation Scientific Center "Russe pole", and come to the examination at least 2 times a year.

PRIMARY OBJECTIVES:

1. To develop a model of a detailed qualification of the health status and physical limitations for children treated for cancer.
2. To develop the rules for choosing methods and means of physical therapy, dosing sessions for duration and intensity, depending on the qualification of the health status and the identified physical limitations.
3. To create a bank of methods and means of physical therapy available for use both in a rehabilitation organization and at home.
4. To develop a software product for Clinical Decision Expert System for corporate management of physical therapy of children treated for cancer and evaluate its effectiveness.

Eligibility criteria: Inclusion Criteria:

* Signing of the agreement with the Medical-Rehabilitation Scientific Center "Russkoe pole".
* Persistent remission not less than 6 months after.
* Age not less than 4 years and not more than 16 years at the time of signing the agreement on participation in the protocol.
* Collaboration with the patient's family and the patient.

Exclusion Criteria:

* The occurence of second tumors.
* Recurrence of cancer.
* Failure to fulfill the obligations under the contract, failure to attend the next survey.

Primary outcomes:
measure: Self-assessment of motor activity
timeFrame: at least 12 studies with an interval of not more than 2 months, a total period of 2 years
Secondary outcomes:
measure: Myocardial contractility
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
measure: The response of the vascular system to submaximal load (6-minute walk test)
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
measure: The neuromuscular support of physical activity
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
measure: Strength endurance of the main muscle groups
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
measure: Energy costs for physical activity
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
measure: The development of motor skills
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
measure: The quality of the postural control
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
measure: The motor activity
timeFrame: at least 12 studies with an interval of not more than 2 months, a total period of 2 years
measure: Tolerance for the physical loads
timeFrame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
Study officials:
affiliation: The National Medical Research Center of Children's Hematology, Oncology and Immunology named after Dmitry Rogachev of the Ministry of Health of the Russian Federation
name: Vladimir N. Kasatkin, professor
role: PRINCIPAL_INVESTIGATOR
References: