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

Determining the effect of the mobile application-based continuous care model on resilience and self-compassion in patients with acute leukemia

A parallel two‑arm randomized controlled trial. Random allocation will be performed using a randomized block design with sealed envelopes.

The trial will be conducted at educational therapeutic centers affiliated with Shahrekord University of Medical Sciences. After screening for eligibility and obtaining informed consent, participants will be randomly allocated to the two groups.

Inclusion Criteria: Informed consent; age ≥18 years; no history of other cancers or prior participation in the continuous care model; Persian literacy; smartphone ownership and ability to use the app; absence of cognitive, hearing, or visual impairments per medical record; and a minimum of 3 months since definitive diagnosis of acute leukemia by a specialist. Exclusion Criteria: Patient death; withdrawal of consent; incomplete questionnaires at any of the three assessments; or irregular app use (less than twice weekly) leading to program discontinuation.

The control group receives usual hospital care (including periodic physician visits and access to common educational pamphlets). The intervention group, in addition to standard care, participates in an 8‑week continuous care model. This model consists of four stages: orientation, sensitization, control, and evaluation. Users are required to use the application at least twice a week, which includes multimedia educational content on the disease, nutrition, symptom management, and specialized modules on resilience and self‑compassion. They also receive weekly support via an in‑app messaging system.

Mean resilience score; Mean self-compassion score.

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.

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.

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.

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.

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.

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

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.

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.