Protocol summary
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Study aim
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Investigation and impact of transitional care program from hospital to home on the quality of life of women with breast cancer and the care burden of their caregivers in two intervention and control groups.
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Design
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A clinical trial with a control group, with parallel groups, not blinded, randomized based on a block of four on 60 patients, due to the lack of drug use, the phase is not valid.
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Settings and conduct
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This study is a randomized controlled clinical trial that will be conducted on women undergoing mastectomy surgery in selected military centers (Baqiyatallah Hospital and Chamran Hospital). Sampling will be done using a four-way block method and will be randomly divided into two intervention and control groups. A transitional care program will be implemented for the intervention group. So that the patients will be provided with educational intervention during four sessions (the first session, before discharge in person and three sessions once a week for up to three weeks after discharge by telephone for 45 minutes).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria
Hospitalized patients who are on postoperative days 1 to 3 following mastectomy surgery.
Having the age of eighteen to seventy years
Breast cancer identified by pathology and treated by surgery
Ability to complete the questionnaire independently
Access to a home phone and mobile phone
Not suffering from mental illnesses
Exclusion criteria
History of chronic diseases
Not living in Tehran
Women over seventy years old
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Intervention groups
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Women with breast cancer who are candidates for mastectomy and meet the inclusion criteria.
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Main outcome variables
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Quality of life, caregiver burden
General information
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Reason for update
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Minor errors in some parts that were entered during incomplete registration
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231203060248N1
Registration date:
2023-12-23, 1402/10/02
Registration timing:
prospective
Last update:
2026-09-07, 1405/06/16
Update count:
1
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Registration date
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2023-12-23, 1402/10/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-04-20, 1403/02/01
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Expected recruitment end date
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2024-07-22, 1403/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of transitional care program from hospital to home on the quality of life of women with breast cancer their family caregiver’s burden
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Public title
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The effectiveness of transitional care program on the quality of life of women with breast cancer and the care burden of their caregivers
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
History of chronic diseases
Women over seventy years old
Non-residence of the person in Tehran
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Age
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From 18 years old to 70 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-24, 1402/08/02
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Ethics committee reference number
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IR.BMSU.BAQ.REC.1402.082
Health conditions studied
1
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Description of health condition studied
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Breast Cancer
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ICD-10 code
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C50.9
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ICD-10 code description
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Malignant neoplasm of breast of unspecified site
Primary outcomes
1
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Description
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Quality of Life
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Timepoint
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before the start of the intervention and three months after the intervention
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Method of measurement
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The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Breast Cancer Module (EORTC QLQ-BR30)
Secondary outcomes
1
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Description
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The care burden of the caregivers
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Timepoint
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before the start of the intervention and three months after the intervention
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Method of measurement
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Zarit Care Burden Assessment Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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The control group will receive routine postoperative care as directed
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bagheiat-allah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data is shared after de-identifying individuals
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When the data will become available and for how long
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Six months after the results are published
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To whom data/document is available
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Everyone will have access to educational content
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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To receive the data, send an email to the address below
marziealighadr25@gmail.com
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What processes are involved for a request to access data/document
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Correspond by email
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Comments
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