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IRCT20231203060248N1 IRCT 2023-12-23 Bagheiat-allah University of Medical Sciences The effectiveness of transitional care program on the quality of life of women with breast cancer and the care burden of their caregivers Effectiveness of transitional care program from hospital to home on the quality of life of women with breast cancer their family caregiver’s burden 2024-04-20 anticipated 60 Complete https://irct.ir/trial/74157 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study is a randomized controlled clinical trial that will be conducted on women undergoing mastectomy in selected military centers. At first, the samples will be randomly divided into intervention and control groups based on the inclusion criteria and selected in a purposeful way and by the quadruple block method. The method of random assignment with blocks of four will be such that letter A will be assigned to the intervention group and letter B will be assigned to the control group, and in blocks of four with letters A and B, six states AABB, BBAA, ABAB, BABA , ABBA, BAAB will be written on separate sheets and thrown in a container. Randomly, one of these sheets will be taken out of the container and the composition written on it will be noted and that sheet will be thrown into the container again. Since the sample size is 60 patients, this procedure will be repeated fifteen times and each time the composition written on the sheet will be noted down after the composition written on the previous sheet. Then, each letter will be assigned a number from one to sixty in the order of the letters written down one after the other. Each of the letters will be placed in an envelope and numbers from one to sixty will be written on the envelope. Each time a patient is selected, one of these envelopes will be opened in order of the number written on the envelope, and it will be determined in which group the patient will be placed. N/A Breast Cancer. Intervention 1: For the intervention group, a structured transitional care program based on these principles will be developed. The program will include four components:1. Preparation for transition:Pre-discharge education on the discharge process, expectations for home care, differences between hospital and home care, and the psychological and physical preparation of patients and caregivers.2. Support and independence:Aims to reduce dependency and increase caregiver and patient self-efficacy through structured education, emotional support, and caregiver participation in providing care.3. How to communicate with the care team4. Integrated and needs-based care:Includes a comprehensive assessment of patient and caregiver needs, personalized care planning, ongoing follow-up, targeted education, and access to support services.The educational content will be delivered by a trained nurse with experience in oncology (researcher) in four sessions (one in person before discharge and three weekly sessions by telephone after discharge, for 45 minutes).In addition to the educational sessions, participants will receive two home visits (at weeks 4 and 8) and weekly telephone follow-ups to assess clinical symptoms, psychosocial status, caregiver needs, and provide tailored counseling. During the home visits, the patients' clinical status (vital signs, blood glucose, weight, mobility, respiratory and mental status) will be monitored and recorded. Intervention 2: The control group will receive routine postoperative care as directed. Yes - There is a plan to make this available What will be shared: All data is shared after de-identifying individuals When: Six months after the results are published To whom: Everyone will have access to educational content Conditions: Access to the outcomes and results of this study will help others to use transitional care to choose the most effective work on the quality of life of women with breast cancer and the care burden of their caregivers. Where to obtain: To receive the data, send an email to the address below marziealighadr25@gmail.com How to obtain: Correspond by email Comments:
public Marzieh Sadat Seyyed Aliqader
Sheikh Bahai South, Nosrati Street, Baqiyatullah Aj University of Medical Sciences
Tehran Iran (Islamic Republic of) 1435916471 +98 21 6448 2797 marziealighadr25@gmail.com Bagheiat-allah University of Medical Sciences scientific Marzieh Sadat Seyyed Aliqader
Sheikh Bahai South, Nosrati Street, Baqiyatullah Aj University of Medical Sciences
Tehran Iran (Islamic Republic of) 1435916471 +98 21 6448 2797 marziealighadr25@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Hospitalized patients who are on postoperative days 1 to 3 following mastectomy surgery. Breast cancer identified by pathology and treated by surgery Ability to complete the questionnaire independently Access to home and mobile phones Residence in Tehran and its suburbs within one month after discharge for the possibility of home visits No mental illness 18 years 70 years Female History of chronic diseases Women over seventy years old Non-residence of the person in Tehran C50.9 Malignant neoplasm of breast of unspecified site Other Other For the intervention group, a structured transitional care program based on these principles will be developed. The program will include four components:1. Preparation for transition:Pre-discharge education on the discharge process, expectations for home care, differences between hospital and home care, and the psychological and physical preparation of patients and caregivers.2. Support and independence:Aims to reduce dependency and increase caregiver and patient self-efficacy through structured education, emotional support, and caregiver participation in providing care.3. How to communicate with the care team4. Integrated and needs-based care:Includes a comprehensive assessment of patient and caregiver needs, personalized care planning, ongoing follow-up, targeted education, and access to support services.The educational content will be delivered by a trained nurse with experience in oncology (researcher) in four sessions (one in person before discharge and three weekly sessions by telephone after discharge, for 45 minutes).In addition to the educational sessions, participants will receive two home visits (at weeks 4 and 8) and weekly telephone follow-ups to assess clinical symptoms, psychosocial status, caregiver needs, and provide tailored counseling. During the home visits, the patients' clinical status (vital signs, blood glucose, weight, mobility, respiratory and mental status) will be monitored and recorded. The control group will receive routine postoperative care as directed Quality of Life. Timepoint: before the start of the intervention and three months after the intervention. Method of measurement: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Breast Cancer Module (EORTC QLQ-BR30). The care burden of the caregivers. Timepoint: before the start of the intervention and three months after the intervention. Method of measurement: Zarit Care Burden Assessment Questionnaire. Bagheiat-allah University of Medical Sciences Approved 2023-10-24 Ethics and Research Committee of Baqiyatullah Azam Educational-Therapeutic Center South Bahai Sheikh, Nosrati Alley, Baqiyatullah Aj University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)