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IRCT20170803035479N3 IRCT 2019-03-01 Tehran University of Medical Sciences Family-centered supportive program and chemotherapy complications Comparing the effect of family-centered supportive program and routine care on chemotherapy complications among leukaemia patients 2019-01-21 anticipated 60 Complete https://irct.ir/trial/34952 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: Blinding of patients, their family and researcher in this study is not possible and only statistician will not be aware of the allocation of patients to control or intervention group. N/A Acute lymphoblastic leukaemia. Intervention 1: Intervention group: The intervention, performed in this study, is a family-based support program (Including family and patient education, determining the type of patient's diet, and psychological support). In order to patient and family member education, pamphlets/ information booklets and educational videos will be prepared. At the first meeting with patients and their family members before starting consolidated Chemotherapy (first stage or second stage), which will be held at the chemotherapy clinics, the training video provided for them will be displayed as well as video and pamphlet given to them. In the session oral explanations on the content of video and educational pamphlets will also be provided for families and patients, and the questions posed by them will be answered. This training session will be held for at least an hour. The number of patients and family members attending this session is based on the number of patients with acute lymphatic leukemia under chemotherapy on that day. After that according to the patient's condition a dietitian will be consulted in order to prepare a patient's diet. Prepared diet will be given to the family member after approval of doctor at the next session of chemotherapy. And guidelines on appropriate nutrition of these patients will be provided for the family. Afterwards, patients and their families will be followed up by phone. During the follow up period, the necessary supportive programs are used in accordance with the new drug or procedure and also controlling the side effects of chemotherapy in families and patients will be presented. Phone follow-up period will be continued for three months during chemotherapy for each patient and their families. Since, Consolidation chemotherapy is performed in these patients phone follow up will be done every two weeks (between two weeks and up to three months). If in the training sessions and in phone follow-up, need to psychological counseling on problems of patients after chemotherapy for patient and the family is confirmed, they will be referred to a psychiatrist at the Hematology Research Center. Intervention 2: Control group: Patients in control group, will be received the only routine intervention of chemotherapy clinics that include oral explanations of staff in the field of chemotherapy. This routine intervention is also being conducted at the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Melika Babazadeh Zanjani
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4325 mlk.babazade@gmail.com Tehran University of Medical Sciences scientific Leila Sayadi
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4322 l-sayadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria for patients: Have age over 18 years old Being able to understand and speak Persian and have the ability to read and write Have awareness of time, place and person Consent to participate in the study Acute lymphatic leukemia have been diagnosed for them For chemotherapy, at least, one of the family members who take care of patient at home accompanies him/her Have been referred to chemotherapy clinic and have being under consolidation chemotherapy Be the first or second turn of consolidation chemotherapy for these people Family members Inclusion Criteria: Have age between 18 to 60 years old Ability to understand Persian language and speak Persian, have ability of reading and writing Being aware of time, place and person being one of the first degree relatives of patient, and providing patient care at home and willing to participate in the study The patient obeys the relative They are personnel of the health system 18 years 60 years Both Patients exclusion criteria: Have history of Chemotherapy in family members being one of the health system personnel Family member exclusion criteria: being one of the health system personnel C91.0 Acute lymphoblastic leukaemia [ALL] Other Other Intervention group: The intervention, performed in this study, is a family-based support program (Including family and patient education, determining the type of patient's diet, and psychological support). In order to patient and family member education, pamphlets/ information booklets and educational videos will be prepared. At the first meeting with patients and their family members before starting consolidated Chemotherapy (first stage or second stage), which will be held at the chemotherapy clinics, the training video provided for them will be displayed as well as video and pamphlet given to them. In the session oral explanations on the content of video and educational pamphlets will also be provided for families and patients, and the questions posed by them will be answered. This training session will be held for at least an hour. The number of patients and family members attending this session is based on the number of patients with acute lymphatic leukemia under chemotherapy on that day. After that according to the patient's condition a dietitian will be consulted in order to prepare a patient's diet. Prepared diet will be given to the family member after approval of doctor at the next session of chemotherapy. And guidelines on appropriate nutrition of these patients will be provided for the family. Afterwards, patients and their families will be followed up by phone. During the follow up period, the necessary supportive programs are used in accordance with the new drug or procedure and also controlling the side effects of chemotherapy in families and patients will be presented. Phone follow-up period will be continued for three months during chemotherapy for each patient and their families. Since, Consolidation chemotherapy is performed in these patients phone follow up will be done every two weeks (between two weeks and up to three months). If in the training sessions and in phone follow-up, need to psychological counseling on problems of patients after chemotherapy for patient and the family is confirmed, they will be referred to a psychiatrist at the Hematology Research Center Control group: Patients in control group, will be received the only routine intervention of chemotherapy clinics that include oral explanations of staff in the field of chemotherapy. This routine intervention is also being conducted at the intervention group. Nausea or vomiting before treatment. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Nausea after treatment. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Vomiting after treatment. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: the Chemotherapy Symptom Assessment Scale. Constipation. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: the Chemotherapy Symptom Assessment Scale. Diarrhea. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Pain. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Shortness of breath. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Signs of infection. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Bleeding or bruising. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Needles/numbness of hands and feet. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Problems with the skin and nails. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Hair loss. Timepoint: Before starting the first or second chemotherapy, and then in each chemotherapy session until 3 months - number of chemotherapy depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. A sore/sensitive mouth or throat. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. A change in appetite. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Weight gain or loss. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Sore/scratchy/dry eyes. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Feeling weakness. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Feeling unusual fatigue. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Difficulty sleeping. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Headaches. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Feeling distressed/anxious. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Feeling pessimistic/unhappy. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Change in sexual life. Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Irregular periods (in female patients). Timepoint: Before starting the first or second chemotherapy sessions, and then in each chemotherapy session until 3 months - number of chemotherapy sessions depend on the chemotherapy protocol. Method of measurement: The Chemotherapy Symptom Assessment Scale. Tehran University of Medical Sciences Approved 2018-12-19 Institutional research ethics committee of Nursing, Midwifery & Rehabilitation school School of Nursing and Midwifery,Tehran University of Medical Sciences, Nosrat street. Tohid sq. Tehran Tehran Iran (Islamic Republic of)