]>
IRCT20180908040970N2 IRCT 2021-11-29 Iran University of Medical Sciences The investigation of the effects of occupational therapy's intervention on occupational performance in advanced cancer patients The Investigation of the effects of Occupational Therapy's Interventions on Occupational Performance in advanced cancer patients at home during covid-19 crisis 2021-11-21 anticipated 70 Complete https://irct.ir/trial/59327 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: After selecting and determining the number of samples, individuals are by using a table of random numbers are divided into two groups (intervention and control). This means that the evaluator and therapist do not interfere in the placement of samples in any of the groups and their placement in each group will be done only through a table of random numbers. Since we have two groups of intervention and control, the total number of samples should be divided into two groups, the number of both groups will be equal. Therefore before the entrance of patients in the study, the total number of samples is divided into two categories. For example, 80 patient samples are needed to study, divide 80 by two, and place 40 patients in each category. The first group of patients will be the control group and the second group of patients will be the intervention group. Then a number will be randomly selected from inside the table of random numbers in the vertical or horizontal direction. After that, the selection of numbers will continue until the first group ends. For example, in a table of random numbers we have a set of 4-digit numbers that are placed in columns and rows. In one of the rows, select a number and select the numbers in pairs. For example, from 4576, two numbers 45 and 76 will be selected. We will proceed in the same way until the first 40 samples are selected. Then, a number in the vertical or horizontal direction will be selected randomly and in the same order as before (in rows or columns) the selection of numbers will continue until the number of second group samples is determined. After the patients enter, the code will be assigned to the patients in the order of their entrance. After matching that code with the desired number in each of the categories, it will be determined in which group the patient will be placed, Blinding description: The assessor does not know the placement of patients in any of the groups during the evaluation. 0 (exploratory trials) Advanced Cancer. Intervention 1: Control group: Receive home-care services and traditional palliative care. Since occupational therapy services are not currently available to cancer patients, if the patient is referred and placed in the control group, the patient will not receive any new intervention and an educational pamphlet Includes introduction of assistive devices and training in their use, adaptive equipment required, compensation techniques, correct bed rest positions and how to transfer the patient are presented. In fact, by providing an educational pamphlet, all the needs of patients and caregivers are considered and the necessary training is given to them, but they will not receive any new occupational therapy intervention. By recording the evaluations in three periods, the results of this group will be compared with the results of the intervention group, which receives palliative medicine interventions in accordance with international standards. Intervention 2: Intervention group: Receiving Home-care services are found to meet international standards and as set out in articles and books. These interventions include occupational therapy treatment strategies such as ADL and IADL-based interventions, observation and management of pain symptoms, fatigue management and energy storage, correction and adaptation of the environment, provision of assistive and adaptive equipment, improvement of functional mobility, home exercises such as stretching, strength training, and range of motion and provide essential health education programs in times of coronary crisis. In other words, after evaluating patients and determining their current condition in all aspects of physical, pain, fatigue and ability to perform daily activities of life, occupational therapy interventions will begin. Occupational therapy interventions focus on all these dimensions and include providing the necessary movement exercises for the foundational skills as movement bases, training in correct positioning to prevent bed sores, joint contractures and muscle injuries, training on how to perform activities. Daily life (personal hygiene, dressing, eating, etc.) in accordance with the patient's abilities and with the aim of increasing the patient's independence in performing them and thus improving the quality of life, providing the necessary aids and if necessary It will be environmental adaptations.It should be noted that all of the above are general interventions that can be provided to these patients and due to the difference in physical condition and type of cancer and the rate of disease progression, the details of each of these interventions will be different in each patient and depends on Evaluation before starting treatment. Yes - There is a plan to make this available What will be shared: All of the data and information on the main and secondary outcomes of the post-print study are shared. When: The access period begins 6 months after the results are published. To whom: Learn to pronounce data will be available only to researchers working in academic and scientific institutions. Conditions: 1. Use data only to evaluate effective therapies. 2. Applicants must be legal entities registered in educational or scientific centers. 3. The applicant shall undertake not to use the data for personal gain or unrelated scientific studies and in other fields. 4. The requesting person shall undertake not to misuse data in unrelated contexts. Where to obtain: The data can be accessed by contacting the following person and sending the requested information up to one week after receiving the request and confirming the conditions: Mahnoosh Khanipour by Email Address: mah.pouroushan@gmail.com How to obtain: Access to the data can be done first via e-mail with the lead researcher studying the correspondence. Subsequently, the necessary information is sent by providing substantiated evidence of the eligibility requirements for the data and confirming the stated evidence and reasons. Also, if the main researcher does not respond, the necessary correspondence can be made with the corresponding author , and the information will be sent again through the conditions and steps mentioned above. Comments:
public Gholamreza Raissi
Neuromusculoskeletal Research Center, Firoozgar hospital, Beh-afarin ave, Karimhanzan ave, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 8214 1612 graissi@gmail.com Iran University of Medical Sciences scientific Mahnoosh Khanipour
No. 17, Unit 1, 240 East Alley, Estakhr St., Tehranpars, Tehran
Tehran Iran (Islamic Republic of) 1659391378 77112441 Mah.pouroushan@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) patients with advanced cancer age range of 18 to 65 years old having an acceptable level of cognitive function as a score of 21 or higher based on the Mini Mental Status Examination (MMSE) In at least one case the Katz questionnaire needs help 18 years 60 years Both Existence of other diseases such as neurological problems, orthopedics and mental disorders. Z51.5 Encounter for palliative care Rehabilitation Rehabilitation Control group: Receive home-care services and traditional palliative care. Since occupational therapy services are not currently available to cancer patients, if the patient is referred and placed in the control group, the patient will not receive any new intervention and an educational pamphlet Includes introduction of assistive devices and training in their use, adaptive equipment required, compensation techniques, correct bed rest positions and how to transfer the patient are presented. In fact, by providing an educational pamphlet, all the needs of patients and caregivers are considered and the necessary training is given to them, but they will not receive any new occupational therapy intervention. By recording the evaluations in three periods, the results of this group will be compared with the results of the intervention group, which receives palliative medicine interventions in accordance with international standards. Intervention group: Receiving Home-care services are found to meet international standards and as set out in articles and books. These interventions include occupational therapy treatment strategies such as ADL and IADL-based interventions, observation and management of pain symptoms, fatigue management and energy storage, correction and adaptation of the environment, provision of assistive and adaptive equipment, improvement of functional mobility, home exercises such as stretching, strength training, and range of motion and provide essential health education programs in times of coronary crisis. In other words, after evaluating patients and determining their current condition in all aspects of physical, pain, fatigue and ability to perform daily activities of life, occupational therapy interventions will begin. Occupational therapy interventions focus on all these dimensions and include providing the necessary movement exercises for the foundational skills as movement bases, training in correct positioning to prevent bed sores, joint contractures and muscle injuries, training on how to perform activities. Daily life (personal hygiene, dressing, eating, etc.) in accordance with the patient's abilities and with the aim of increasing the patient's independence in performing them and thus improving the quality of life, providing the necessary aids and if necessary It will be environmental adaptations.It should be noted that all of the above are general interventions that can be provided to these patients and due to the difference in physical condition and type of cancer and the rate of disease progression, the details of each of these interventions will be different in each patient and depends on Evaluation before starting treatment. Occupational Performance rate in the Canadian Occupational Performance Measure. Timepoint: Time intervals for evaluation at the beginning of the study(before the interventions), and by passing 6nd, and 14th weeks from the intervention(Follow-up). Method of measurement: Canadian Occupational Performance Measure(COPM). Level of Quality Of Life. Timepoint: Time intervals for evaluation at the beginning of the study(before the interventions), and by passing 6nd, and 14th weeks from the intervention(Follow-up). Method of measurement: European Organization for Research and Treatment of Cancer-of-life Questionnaire Core30 (EORTC QLQ-30 ). Ability to perform Activities of Daily Living. Timepoint: Time intervals for evaluation at the beginning of the study(before the interventions), and by passing 6nd, and 14th weeks from the intervention(Follow-up). Method of measurement: Katz Index. Ability to perform Instrumental Activities of Daily Living. Timepoint: Time intervals for evaluation at the beginning of the study(before the interventions), and by passing 6nd, and 14th weeks from the intervention(Follow-up). Method of measurement: The Lawton Instrumental Activity of Daily Living. The amount of pain. Timepoint: Time intervals for evaluation at the beginning of the study(before the interventions), and by passing 6nd, and 14th weeks from the intervention(Follow-up). Method of measurement: Brief Pain Inventory. The amount of fatigue. Timepoint: Time intervals for evaluation at the beginning of the study(before the interventions), and by passing 6nd, and 14th weeks from the intervention(Follow-up). Method of measurement: Cancer Fatigue Scale. Iran University of Medical Sciences Approved 2021-09-28 Research Ethics Committees of Iran University of Medical Science Neuromusculoskeletal Research Center, Firoozgar hospital, Beh-afarin ave, Karimhanzan ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)