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IRCT20260128068679N1 IRCT 2026-02-06 Shahre-kord University of Medical Sciences Effect of the Continuous Care Model Based on Mobile Application in Patients with Acute Leukemia The Effect of the Continuous Care Model Based on Mobile Application Compared with Usual Care on Resilience and Self-Compassion in Patients with Acute Leukemia 2026-04-21 anticipated 74 Complete https://irct.ir/trial/88823 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be gradually enrolled using a convenience sampling method based on the eligibility criteria and will be randomly assigned to the intervention and control groups. Randomization will be performed using block randomization with variable block sizes. In this method, the letter "A" represents the control group and the letter "B" represents the intervention group. Various possible combinations of these two groups will be written on cards, each placed inside sealed, opaque envelopes. To ensure allocation concealment, blocks of different sizes—such as six-member blocks (e.g., ABBABA) and two-member blocks (e.g., AB, BA)—will be used. The envelopes will be kept in a box, and the researcher will remain unaware of the group assignments until a card is selected. Before enrolling each participant, a nurse blinded to the study aims and group assignments will randomly select an envelope from the box, determining the group to which the participant will be allocated.This process will continue until all cards have been used, after which the cards will be returned to the box and the random selection process will be repeated until the desired sample size is achieved. N/A Condition 1: Acute myeloblastic leukemia. Condition 2: Acute lymphoblastic leukemia [ALL]. Intervention 1: Control group: The control group receives the hospital's usual care (including periodic physician visits and access to common educational pamphlets). Intervention 2: Intervention group: In addition to standard care, patients participate in a follow-up care model for 8 weeks. This model consists of four stages:(1) Orientation: A 45-minute training session for installing and learning how to use the application.(2) Sensitization: Access to the application, which includes multimedia educational content about the disease, nutrition, symptom management, and specialized modules on resilience and self-compassion (including audio/video files and interactive exercises). Users are required to use the application at least twice a week and receive daily motivational messages.(3) Control: Weekly support through an in-app messaging system and phone calls when needed.(4) Evaluation: Continuous monitoring of app usage and a final assessment. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data (IPD) set: This set includes all collected data after the removal of identifiers. The main components are: (1) baseline demographic data (e.g., age, gender, education level), and (2) complete baseline, immediately post-intervention, and two-month follow-up scores from the Connor-Davidson Resilience Scale and the Self-Compassion Scale. When: The deidentified individual participant data and related documents will be made accessible in a public data repository no later than 6 months after the online publication of the primary results in a peer-reviewed journal. The data and documents will remain available for a minimum of 5 years from the date of first sharing in the repository. To whom: Available to researchers affiliated with academic, healthcare, or non-profit research institutions worldwide, for the purpose of conducting scientific research. Access is not restricted based on geography or sector, but applicants must demonstrate an ethical approval for their proposed analysis. Conditions: Data may be requested for reanalysis, secondary analysis, individual participant data meta-analysis, or methodological research. Requests for commercial use are not permitted. All proposed analyses must have ethics committee approval. A Data Use Agreement (DUA) outlining terms of use, privacy, and publication must be signed prior to access. Where to obtain: All correspondence must be conducted in Persian or English. Primary Contact: Sogand Solaimaninezadian Affiliation: Shahrekord University of Medical Sciences Postal Address: Central Administration Building, Kashani Blvd, Shahrekord, Postal Code: 8815713471 Email: st-soleimaninejadian.s@skums.ac.ir How to obtain: Initial Request: The applicant submits a formal email request to the Principal Investigator (see contact details above). The email must include: A brief research proposal (max. 2 pages) detailing the study objectives, methodology, and planned analyses. A valid ethics approval letter from the applicant's institutional review board (IRB) or ethics committee. A completed Data Request Form (the template will be provided upon initial inquiry). Administrative and Scientific Review: The request is first checked for completeness. It is then reviewed by a Data Access Committee (DAC) established for this study, consisting of the Principal Investigator and at least one independent senior faculty member from the Faculty of Nursing and Midwifery. The DAC evaluates the scientific merit, feasibility, and ethical compliance of the proposed project. Data Use Agreement (DUA): If approved, the applicant will be sent a Data Use Agreement (DUA) draft. This legally binding document outlines the terms of data use, confidentiality obligations, publication policies, and data destruction protocols. The finalized DUA must be signed by an authorized representative of the applicant's institution and returned. Data Preparation and Transfer: Upon receipt of the fully executed DUA, the deidentified data sets and supporting documents (e.g., data dictionary, analysis code) will be prepared and transferred to the applicant via a secure method (e.g., encrypted email or secure university file-sharing service). Overall Timeline: Applicants should expect the entire process, from submission of a complete application to data transfer, to take approximately 6 to 8 weeks, depending on the completeness of the initial submission and the speed of correspondence and contract execution. Comments: This data sharing plan aligns with the principles of the ICMJE and the FAIR (Findable, Accessible, Interoperable, Reusable) guiding principles for scientific data management. We are committed to responsible data sharing to maximize the scientific value of the contributions made by our study participants.
public Sogand Soleimaninejadian
No. 17, Alley 11, Moallem Blvd
Shahrekord Iran (Islamic Republic of) 8814855131 +98 38 3334 6015 st-soleimaninejadian.s@skums.ac.ir Shahre-kord University of Medical Sciences scientific Sogand Soleimaninejadian
No. 17, Alley 11, Moallem Blvd
Shahrekord Iran (Islamic Republic of) 8814855131 +98 38 3334 6015 st-soleimaninejadian.s@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study and provision of written informed consent. Age of at least 18 years. No history of other malignancies. No prior participation in a continuous care model program. Ability to read and write in Persian. Ownership of a smartphone and ability to use the mobile application. No cognitive, hearing, or visual impairments based on the patient’s medical records. Access to the internet and basic digital literacy required to use the mobile application. At least three months have elapsed since the definitive diagnosis of acute leukemia by a specialist physician. 18 years no limit Both Death of the participant. Participant’s unwillingness to continue participation in the study. Failure to complete the questionnaires at any of the three assessment time points (before the intervention, immediately after the intervention, and two months after the intervention). Withdrawal from the care program during the study due to non-adherence to the intervention, defined as using the application fewer than two times per week. C92.0 C91.0 Acute myeloblastic leukemia Acute lymphoblastic leukemia [ALL] Behavior Behavior Control group: The control group receives the hospital's usual care (including periodic physician visits and access to common educational pamphlets). Intervention group: In addition to standard care, patients participate in a follow-up care model for 8 weeks. This model consists of four stages:(1) Orientation: A 45-minute training session for installing and learning how to use the application.(2) Sensitization: Access to the application, which includes multimedia educational content about the disease, nutrition, symptom management, and specialized modules on resilience and self-compassion (including audio/video files and interactive exercises). Users are required to use the application at least twice a week and receive daily motivational messages.(3) Control: Weekly support through an in-app messaging system and phone calls when needed.(4) Evaluation: Continuous monitoring of app usage and a final assessment. The mean total score of patients on the Connor-Davidson Resilience Scale (CD-RISC). Timepoint: The questionnaire will be completed at three time points: at the beginning of the study (before the start of the intervention), at the end of the eighth week (immediately after the completion of the intervention period), and eight weeks after the end of the intervention. Method of measurement: Connor-Davidson Resilience Scale - 25 Item. The mean total score of patients on the Self-Compassion Scale – Short Form (SCS–SF). Timepoint: The questionnaire will be completed at three time points: at the beginning of the study (before the start of the intervention), at the end of the eighth week (immediately after the completion of the intervention period), and eight weeks after the end of the intervention. Method of measurement: Self-Compassion Scale – Short Form , 12-item version. Shahre-kord University of Medical Sciences Approved 2026-01-27 Ethics Committee of Shahrekord University of Medical Sciences Central Administration Building, Kashani Boulevard, Shahrekord, Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)