Childhood Acute Lymphoblastic Leukemia in RemissionNCT03586401
Creating a Decision Support System for the Corporate Management of Physical Therapy
An observational study of Childhood Acute Lymphoblastic Leukemia in Remission and Childhood Brain Tumor, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Brain Tumor, Physical Activity
- How many people
- 1,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2017to 21 May 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- The occurence of second tumors.
- Recurrence of cancer.
- Failure to fulfill the obligations under the contract, failure to attend the next survey.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
Moscow, 117997
Alexandr Ph Karelin, PhD, +7(495)287-6570 ext. 2400, Alexandr.Karelin@fccho-moscow.ru
Dmitryi V. Skvorcov, priofessor
About this study
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
Read the 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:
- To develop a model of a detailed qualification of the health status and physical limitations for children treated for cancer.
- 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.
- To create a bank of methods and means of physical therapy available for use both in a rehabilitation organization and at home.
- 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.
- 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
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Childhood Cancer Survivors | The study will be attended by 1000 families with children who have completed treatment for cancer at least 6 months before the start of the trial and undergo rehabilitation courses at the Medical and Rehabilitation Research Center "Russkoe pole" at least twice a year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessment of motor activity
Based on The International Physical Activity Questionnaire (IPAQ). The patient or his parents fill out a special questionnaire, that contains questions about the motor activity in 4 areas: leisure, activity at home and in the garden, activities related to work and activities related to transport. The main indicator is the the MET (Metabolic Equivalent of Task) per week: MET level x minutes of activity x events per week.
Three levels (categories) of physical activity are proposed. High - 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week Moderate - 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.
Low - Those individuals who not meet criteria for categories 1 or 2 are considered low/inactive.
Measured: at least 12 studies with an interval of not more than 2 months, a total period of 2 years
Secondary outcomes (9)
Myocardial contractility
The contractility of the left ventricle of the myocardium is considered a functional indicator of the overall endurance of a person. Diagnosis of myocardial contractility is carried out on the basis of echocardiography, the main indicator is the ejection fraction. Evaluation of myocardial contractility will be conducted in accordance with the Guidelines of the European Society of Cardiology 2016: normal or preserved LVEF ≥50% (HFpEF); moderately reduced LVEF in the range of 40-49% (HFmrEF); reduced LVEF <40% (HFrEF).
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The response of the vascular system to submaximal load (6-minute walk test)
Based on the changes in the parameters of ultrasound of the vessels of skeletal muscles (arms and legs), at rest and after a 6-minute walk test. As the main indicator, the velocity of volumetric blood flow in the examined vessel in ml / min.
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The neuromuscular support of physical activity
Based on electromyography: an evaluation of the activity of the rectus femoris muscle, anterior tibial and gastrocnemius muscles.
It is estimated as the amplitude with the direct effort in the muscle, and the synkinetic ratio of the amplitudes of the maximum force of the dorsiflexion and plantar extension.
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
Strength endurance of the main muscle groups
Based on a series of simply organized movements: holding the raised leg, holding the weighting agent in the withdrawn hand, holding the body in a horizontal position on the back, or on the stomach. The longer the posture is held, the higher the endurance. The force endurance coefficient is calculated by the formula obtained by the authors through a multifactor analysis of the indices in a study involving healthy volunteers.
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
Energy costs for physical activity
Based on metabolography at rest and on the background of submaximal load. The basal metabolic rate (count of MET at rest) is calculated and during the 6-minute walk test, an anaerobic threshold is determined.
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The development of motor skills
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. During the series of tasks the comprehensive measure of gross and fine motor skills are assessed, total 8 scales: 1. Accuracy of fine motor skills (from 0 to 14 points), 2. Integrating fine motor skills (from 0 to 10 points), 3. Sleight of hand (from 0 to 9), 4. Bilateral skills (0 to 7 points), 5 Balance (from 0 to 8 points), 6. Running speed and agility (from 0 to 10 points), 7. Coordination of the upper extremities (from 0 to 12 points), 8. Strength (from 0 to 18 points). The higher the score, the better developed the motor skill. The overall score is defined as the sum of scores on individual scales.
With the help of special metric tables determine the correspondence of the result to the sex-age norm.
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The quality of the postural control
Based on the stabilometry, conducted in the position with open eyes and closed eyes (Romberg test). The main indicator is the area of the statokinesiogram (in mm).
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The motor activity
The monitoring of a motor activity with the use of personal measuring devices of motor activity of the Omron HJ-152 Pedometer type. Counting the number of aerobic steps per day: continuous walking at a speed of more than 60 steps per minute for 10 minutes or more
Measured: at least 12 studies with an interval of not more than 2 months, a total period of 2 years
Tolerance for the physical loads
Based on a 6-minute walk test. The distance covered in 6 minutes is fixed. The greater the distance, the higher the tolerance.
Measured: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start1 Nov 2017
- Primary completion21 May 2019 (estimated)
- Study completion21 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Acute Lymphoblastic Leukemia in RemissionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafima Chechelnitskaya, Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Investigators
- Vladimir N. Kasatkin, professor, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586401
- Sponsor's protocol ID
- 9э/4-17
- Status last verified
- Jun 2018
- First submitted
- 25 May 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Decision Support System for the Corporate Management of Physical Therapy
- ClinicalTrials.gov ID
- NCT03586401
- Acronym / sponsor ID
- 9э/4-17
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 21 May 2019 (estimated)
- Study completion
- 21 May 2020 (estimated)
- First posted
- 13 Jul 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 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:
- To develop a model of a detailed qualification of the health status and physical limitations for children treated for cancer.
- 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.
- To create a bank of methods and means of physical therapy available for use both in a rehabilitation organization and at home.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Childhood Cancer Survivors | – | –The study will be attended by 1000 families with children who have completed treatment for cancer at least 6 months before the start of the trial and undergo rehabilitation courses at the Medical and Rehabilitation Research Center "Russkoe pole" at least twice a year. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- The occurence of second tumors.
- Recurrence of cancer.
- Failure to fulfill the obligations under the contract, failure to attend the next survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-assessment of motor activity
Time frame: at least 12 studies with an interval of not more than 2 months, a total period of 2 years
Based on The International Physical Activity Questionnaire (IPAQ). The patient or his parents fill out a special questionnaire, that contains questions about the motor activity in 4 areas: leisure, activity at home and in the garden, activities related to work and activities related to transport. The main indicator is the the MET (Metabolic Equivalent of Task) per week: MET level x minutes of activity x events per week. Three levels (categories) of physical activity are proposed. High - 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week Moderate - 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week. Low - Those individuals who not meet criteria for categories 1 or 2 are considered low/inactive.
9 secondary outcomes
Myocardial contractility
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The response of the vascular system to submaximal load (6-minute walk test)
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The neuromuscular support of physical activity
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
Strength endurance of the main muscle groups
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
Energy costs for physical activity
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The development of motor skills
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The quality of the postural control
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
The motor activity
Time frame: at least 12 studies with an interval of not more than 2 months, a total period of 2 years
Tolerance for the physical loads
Time frame: at least 4 studies with an interval of not more than 6 months, a total period - 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Vladimir N. Kasatkin, professor principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Acute Lymphoblastic Leukemia in Remission and Childhood Brain Tumor, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Jul 2018. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serafima M. Chechelnitskaya, professor (+79168128163, dar-2006@bk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessment of motor activity (time frame: at least 12 studies with an interval of not more than 2 months, a total period of 2 years). 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 13 Jul 2018.