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IRCT20250112064366N1 IRCT 2025-02-22 Babol University of Medical Sciences Effect of family education on the attitude towards cancer in patients with cancer Effect of Family-Centered Empowerment Model on Cancer-stigma in patients with cancer 2025-04-03 anticipated 80 Complete https://irct.ir/trial/81279 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals are selected through convenience sampling and are randomly divided into two groups: control and intervention. To achieve randomization, a method of drawing sealed envelopes is used. In this method, a number of envelopes are designated by the researcher for the intervention group, and the same number of envelopes is allocated for the control group. Then, by merging the envelopes together (drawing the envelopes), one envelope is drawn and its allocation is recorded. After being drawn, that envelope is returned to the collection of other envelopes. Then the letters are merged again, and another letter is produced. This process continues until a random sequence corresponding to the sample size is reached. The concealment of random allocation is also carried out using opaque envelopes that are sealed with a random sequence. In this method, a random sequence is first generated using the mentioned method. Then, based on the sample size of the research, a number of letters are prepared with aluminum envelopes (to ensure the content of the letters is not visible), and each of the generated random sequences is recorded on one letter. The letters are then placed in the envelopes in order. In order to maintain a random sequence, the envelopes are numbered on the outside in the same order. Finally, the flaps of the envelopes are sealed and placed in a box in order. At the time of starting the registration of participants, based on the order of arrival of eligible participants for the study, one of the envelopes is opened in sequence, revealing the assigned group of that participant. The intervention and control groups are matched based on the average ratio of gender and age, Blinding description: In this study, a single-blind method will be used for the patients. In this way, for the intervention group, in addition to providing routine care, family-centered empowerment model will be conducted for the patient and their family caregiver, while the control group will only receive routine cancer-related care. It is worth mentioning that none of the participants will be aware of which group they belong to. N/A Condition 1: Digestive system cancer. Condition 2: Digestive system cancer. Condition 3: Digestive system cancer. Condition 4: Digestive system cancer. Condition 5: Digestive system cancer. Condition 6: Digestive system cancer. Condition 7: Digestive system cancer. Condition 8: Digestive system cancer. Condition 9: Digestive system cancer. Condition 10: Digestive system cancer. Condition 11: Digestive system cancer. Condition 12: Digestive system cancer. Condition 13: Urinary-reproductive system cancer. Condition 14: Urinary-reproductive system cancer. Condition 15: Urinary-reproductive system cancer. Condition 16: Urinary-reproductive system cancer. Condition 17: Urinary-reproductive system cancer. Condition 18: Urinary-reproductive system cancer. Condition 19: Urinary-reproductive system cancer. Condition 20: Urinary-reproductive system cancer. Condition 21: Urinary-reproductive system cancer. Condition 22: Urinary-reproductive system cancer. Condition 23: Urinary-reproductive system cancer. Condition 24: Urinary-reproductive system cancer. Condition 25: Urinary-reproductive system cancer. Condition 26: Urinary-reproductive system cancer. Condition 27: Urinary-reproductive system cancer. Condition 28: Urinary-reproductive system cancer. Condition 29: Urinary-reproductive system cancer. Condition 30: Urinary-reproductive system cancer. Condition 31: Circulatory system cancer. Condition 32: Circulatory system cancer. Condition 33: Circulatory system cancer. Condition 34: Circulatory system cancer. Condition 35: Circulatory system cancer. Condition 36: Circulatory system cancer. Condition 37: Circulatory system cancer. Condition 38: Circulatory system cancer. Condition 39: Circulatory system cancer. Condition 40: Circulatory system cancer. Condition 41: Circulatory system cancer. Condition 42: Circulatory system cancer. Condition 43: Circulatory system cancer. Condition 44: Circulatory system cancer. Intervention 1: In this group, the patient and his family caregiver, who is one of his first-class people, in addition to receiving routine cancer care and treatment, family-oriented training based on empowerment in 4 steps including 1. Understanding the threat, 2. Improving self-efficacy/problem solving, 3. Improving self-confidence and self-esteem through educational participation and 4. They will receive evaluation. Intervention 2: Control group: This group only receives routine cancer care and treatment, and training based on family empowerment will not be implemented for this group of patients. Yes - There is a plan to make this available What will be shared: After the end of the study and data analysis, the results and data including study protocol, statistical analysis map, clinical study report after removing confidential information will be available to all people who want to access and use this study When: Beginning of the access period from 2026 To whom: All people Conditions: Access is free Where to obtain: Applicants can receive documents through the email address elhamegzb75@gmail.com. How to obtain: Applicants should proceed with a full explanation of the purpose of accessing data and documents through a signed and official letter. Approximate time to send documents is 2 weeks. Comments:
public Elham Emamgholizadeh Baboli
Babol University of Medical Sciences, Ganj Afrooz St., Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0105 elhamegzb75@gmail.com Babol University of Medical Sciences scientific Elham Emamgholizadeh Baboli
Babol University of Medical Sciences, Ganj Afrooz St., Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0105 elhamegzb75@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) The diagnosis and type of cancer in the patient's file should be recorded by the physician The patient should be suffering from cancer related to the digestive system, circulatory system, and urinary-reproductive system (considering the widespread prevalence of these cancers in Mazandaran province) At least 6 months should have passed since the onset of the cancer The patient should be able to communicate verbally with the researcher The patient's age should be over 18 years The patient must have at least basic reading and writing skills There should be the possibility of accessing the patient after discharge from the hospital The patient and the family caregiver must be fluent in Persian The family caregiver should be between the ages of 18 and 60 The family caregiver should not have a history of caring for a cancer patient The family caregiver should have the ability to read and write The family caregiver should have the ability to use virtual environment by a smartphone 18 years no limit Both The patient and the family caregiver do not want to attend the meetings The patient and the family caregiver are among the health care providers The patient has mental problems and learning disorders (recording mental and learning disorders in the patient's file and history of previous illnesses and taking antipsychotic drugs) The family caregiver has a mental problem (taking antipsychotic drugs) C16 C15 C17 C18 C19 C20 C21 C22 C23 C24 C25 C26 C50 C51 C52 C53 C54 C55 C56 C57 C58 C60 C61 C62 C63 C64 C65 C66 C67 C68 C81 C82 C83 C84 C85 C86 C88 C90 C91 C92 C93 C94 C95 C96 Malignant neoplasm of stomach Malignant neoplasm of esophagus Malignant neoplasm of small intestine Malignant neoplasm of colon Malignant neoplasm of rectosigmoid junction Malignant neoplasm of rectum Malignant neoplasm of anus and anal canal Malignant neoplasm of liver and intrahepatic bile ducts Malignant neoplasm of gallbladder Malignant neoplasm of other and unspecified parts of biliary tract Malignant neoplasm of pancreas Malignant neoplasm of other and ill-defined digestive organs Malignant neoplasm of breast Malignant neoplasm of vulva Malignant neoplasm of vagina Malignant neoplasm of cervix uteri Malignant neoplasm of corpus uteri Malignant neoplasm of uterus, part unspecified Malignant neoplasm of ovary Malignant neoplasm of other and unspecified female genital organs Malignant neoplasm of placenta Malignant neoplasm of penis Malignant neoplasm of prostate Malignant neoplasm of testis Malignant neoplasm of other and unspecified male genital organs Malignant neoplasm of kidney, except renal pelvis Malignant neoplasm of renal pelvis Malignant neoplasm of ureter Malignant neoplasm of bladder Malignant neoplasm of other and unspecified urinary organs Hodgkin lymphoma Follicular lymphoma Non-follicular lymphoma Mature T/NK-cell lymphomas Other specified and unspecified types of non-Hodgkin lymphoma Other specified types of T/NK-cell lymphoma Malignant immunoproliferative diseases and certain other B-cell lymphomas Multiple myeloma and malignant plasma cell neoplasms Lymphoid leukemia Myeloid leukemia Monocytic leukemia Other leukemias of specified cell type Leukemia of unspecified cell type Other and unspecified malignant neoplasms of lymphoid, hematopoietic and related tissue Other Other In this group, the patient and his family caregiver, who is one of his first-class people, in addition to receiving routine cancer care and treatment, family-oriented training based on empowerment in 4 steps including 1. Understanding the threat, 2. Improving self-efficacy/problem solving, 3. Improving self-confidence and self-esteem through educational participation and 4. They will receive evaluation. Control group: This group only receives routine cancer care and treatment, and training based on family empowerment will not be implemented for this group of patients Cancer stigma score in the (A questionnaire for measuring attitudes toward cancer (cancer stigma). Timepoint: Measuring cancer stigma at the beginning of the study (before the start of the intervention) in both the intervention and control groups and 30 days after the start of the study in the control group and 75 days after the start of training in the intervention group. Method of measurement: Questionnaire for measuring attitudes toward cancer (cancer stigma). Babol University of Medical Sciences Approved 2024-11-18 Research Ethics Committees of Health Research Institute - Babol University of Medical Sciences Babol University of Medical Sciences, Ganj Afrooz St., Babol Babol Mazandaran Iran (Islamic Republic of)