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IRCT20200926048842N3 IRCT 2023-03-21 Semnan University of Medical Sciences The Effect Of Continuous Care Model On The Quality Of Life And Adherence To Treatment In Breast Cancer Patients Undergoing Chemotherapy Investigating The Effect Of Continuous Care Model On The Quality Of Life And Adherence To Treatment In Breast Cancer Patients Undergoing Chemotherapy 2023-03-13 anticipated 62 Complete https://irct.ir/trial/69211 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: After selection, in order to standardize the research conditions for both intervention and control groups, the random allocation method will be used. If the patient is in the intervention group, Continuous Care Model will be performed, but no intervention will be performed for the control group, Randomization description: Sampling will be done by available methods. Every female patient with breast cancer referring to Kausar (Semnan city) and Bahar (Shahroud city) hospitals who meet the inclusion criteria will be included in the study. Then the selected patients are randomly divided into two groups of intervention and control. In this way, first, an envelope containing the group name is prepared for the total number of people studied and randomly arranged, and with the gradual referral and selection of individuals, one of the cards will be assigned to them, respectively; Which will determine the individual group in the intervention or control group. Due to random sampling, the samples will have an equal chance of being selected in both intervention and control groups. N/A The Effect Of Continuous Care Model On The Quality Of Life And Adherence To Treatment In Breast Cancer Patients Undergoing Chemotherapy. Intervention 1: Intervention group: Before implementing the intervention with therapeutic communication techniques, the researcher will explain the intervention to the patient. This care technique includes 4 stages (familiarity - sensitization - control - evaluation). . 1- Familiarization stage: It is considered as the starting point and the first meeting will be held in order to justify and encourage the patient and his family and to feel the necessity of the follow-up process of the patients within 30-45 minutes with the presence of the patient and his family. At this stage, the researcher and the patient and his family will get to know each other. He will express his expectations and make recommendations on the necessity of continuing and even if possible not interrupting the therapeutic care relationship between the parties until the end of the appointed time. The actions of this stage of interventions include: introducing the researcher to the patient and family, completing the demographic information questionnaire and quality of life and compliance with the patient's treatment by the researcher, determining and agreeing on the time of the patient's visit to the relevant medical centers (this time is based on the wishes of the patient and the family) will be determined) and the time of phone calls and how to communicate (according to the patient and family) will also be discussed. A follow-up will be held in the implementation of the research (chemotherapy department of Kausar and Bahar hospitals) face-to-face and with the coordination of the clinic officials, the patient and their family for 45-60 minutes and according to the level of tolerance. Also, during the individual interaction between the researcher and the patient, preliminary questions will be asked to identify their level of awareness (about breast cancer and its complications, self-care behaviors and treatment recommendations). The content of the educational program will be adjusted according to the latest articles and consultation with expert professors. The number of sessions for each sample will depend on the patient's level of awareness and knowledge. On average, 6 sessions and three times a week with the presence of the patient and family based on the time set in the familiarization phase, according to the request of the patient and family, will be held face to face and individually in the relevant department, and at the end of the sessions, an educational platform including an educational booklet will be provided. The patient and family will be placed. 3- Control stage: The purpose of this stage is to continue the process of continuous care implementation. There is no doubt that the most appropriate programs without control and follow-up will be forgotten with the passage of time or lose their desired effect. Therefore, considering that the model used is called continuous care, the researcher communicates with the patient and family once a week through a telephone call (the day, week and time of the call are coordinated with the patient and family during the sensitization phase) and through the checklist. Care and education ensures that the interventions are carried out, in addition to that, he asks questions from the patient in relation to the training given to ensure that he has learned the content of the training sessions. If the patient had a problem in doing and learning the given training, a reminder training session will be given to him again. Also, the researcher made an appointment with the patients and their families to call the researcher's mobile phone and solve their problem if they face any question or problem at home. For 3 months, follow-up care by phone (once a week) will be carried out repeatedly with the aim of checking the care process (through the care checklist and asking questions). 4- Evaluation stage: The fourth and final step of the model. Evaluation is presented as the final stage of the continuous care model, but it is considered and ongoing in all stages of the study. In this study, the evaluation will be done in two stages. The first stage after one month and the second stage after three months of the implementation of the model, the researcher coordinates the time and place during the phone call with the patient and the quality of life and treatment compliance questionnaires are completed again. The duration of the intervention is 4 months. Intervention 2: Control group: If the patient is assigned to the control group, first, to start the pre-test, the demographic information questionnaire, the standard questionnaire of quality of life and compliance with the treatment was completed by the researcher, and this group received no intervention except for routine care that is applicable in medical centers for patients with Breast cancer, including blood samples and chemotherapy, etc. are not received. Then the test will be completed simultaneously with the intervention group during a phone call by the researcher, the time of which is based on the wishes of the patient and his family, one and three months later. At the end of the intervention, the educational booklet containing the educational materials will be provided to the patient and the family of the control 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 Sajad Salehipour
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
Shahroud Iran (Islamic Republic of) 3619676483 +98 23 3237 3188 ssn.shahroud@yahoo.com Semnan University of Medical Sciences scientific Sajad Salehipour
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
Shahroud Iran (Islamic Republic of) 3619676483 +98 23 3237 3188 ssn.shahroud@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age above 18 years Not having problems such as mental retardation, mental behavioral disorder and hearing according to the patients medical record Failure to participate in similar training courses Having minimum literacy to read and write and use of a continuing care program Having breast cancer for at least 1 year Female gender Having a mobile phone personally or in the family or having a fixed phone in the place of residence A native of Semnan province Complete consent of the patient and family to refer and follow up a phone number, a purpose of treatment and continuing training and counseling required by the researcher 18 years no limit Female The occurrence of severe physical complications caused by the disease Death of the patient Metastasis to other parts and organs of the body Unwillingness to continue cooperation Absence of more than two sessions C50.9 Breast, unspecified Rehabilitation Rehabilitation Intervention group: Before implementing the intervention with therapeutic communication techniques, the researcher will explain the intervention to the patient. This care technique includes 4 stages (familiarity - sensitization - control - evaluation). . 1- Familiarization stage: It is considered as the starting point and the first meeting will be held in order to justify and encourage the patient and his family and to feel the necessity of the follow-up process of the patients within 30-45 minutes with the presence of the patient and his family. At this stage, the researcher and the patient and his family will get to know each other. He will express his expectations and make recommendations on the necessity of continuing and even if possible not interrupting the therapeutic care relationship between the parties until the end of the appointed time. The actions of this stage of interventions include: introducing the researcher to the patient and family, completing the demographic information questionnaire and quality of life and compliance with the patient's treatment by the researcher, determining and agreeing on the time of the patient's visit to the relevant medical centers (this time is based on the wishes of the patient and the family) will be determined) and the time of phone calls and how to communicate (according to the patient and family) will also be discussed. A follow-up will be held in the implementation of the research (chemotherapy department of Kausar and Bahar hospitals) face-to-face and with the coordination of the clinic officials, the patient and their family for 45-60 minutes and according to the level of tolerance. Also, during the individual interaction between the researcher and the patient, preliminary questions will be asked to identify their level of awareness (about breast cancer and its complications, self-care behaviors and treatment recommendations). The content of the educational program will be adjusted according to the latest articles and consultation with expert professors. The number of sessions for each sample will depend on the patient's level of awareness and knowledge. On average, 6 sessions and three times a week with the presence of the patient and family based on the time set in the familiarization phase, according to the request of the patient and family, will be held face to face and individually in the relevant department, and at the end of the sessions, an educational platform including an educational booklet will be provided. The patient and family will be placed. 3- Control stage: The purpose of this stage is to continue the process of continuous care implementation. There is no doubt that the most appropriate programs without control and follow-up will be forgotten with the passage of time or lose their desired effect. Therefore, considering that the model used is called continuous care, the researcher communicates with the patient and family once a week through a telephone call (the day, week and time of the call are coordinated with the patient and family during the sensitization phase) and through the checklist. Care and education ensures that the interventions are carried out, in addition to that, he asks questions from the patient in relation to the training given to ensure that he has learned the content of the training sessions. If the patient had a problem in doing and learning the given training, a reminder training session will be given to him again. Also, the researcher made an appointment with the patients and their families to call the researcher's mobile phone and solve their problem if they face any question or problem at home. For 3 months, follow-up care by phone (once a week) will be carried out repeatedly with the aim of checking the care process (through the care checklist and asking questions). 4- Evaluation stage: The fourth and final step of the model. Evaluation is presented as the final stage of the continuous care model, but it is considered and ongoing in all stages of the study. In this study, the evaluation will be done in two stages. The first stage after one month and the second stage after three months of the implementation of the model, the researcher coordinates the time and place during the phone call with the patient and the quality of life and treatment compliance questionnaires are completed again. The duration of the intervention is 4 months. Control group: If the patient is assigned to the control group, first, to start the pre-test, the demographic information questionnaire, the standard questionnaire of quality of life and compliance with the treatment was completed by the researcher, and this group received no intervention except for routine care that is applicable in medical centers for patients with Breast cancer, including blood samples and chemotherapy, etc. are not received. Then the test will be completed simultaneously with the intervention group during a phone call by the researcher, the time of which is based on the wishes of the patient and his family, one and three months later. At the end of the intervention, the educational booklet containing the educational materials will be provided to the patient and the family of the control group. The score that the patient receives from the specific quality of life questionnaire for cancer patients (EORTC QLQ-C30) ranges from 30 to 126. Timepoint: It is before the start of the intervention and one month and three months after the end of the intervention. Method of measurement: The score obtained by the patient from the questionnaire (EORTC QLQ-C30) which is specific for cancer patients and includes 9 subscales and mostly 30 questions in the range of 126-30. This questionnaire includes 5 functional domains, 9 symptom domains and one general domain of quality of life. This questionnaire is based on a four-point Likert scale. Not at all (score 1), a little (score 2), a bit (score 3), very much (score 4). To calculate the score of each subscale, the score of each item related to that subscale is added together. The minimum and maximum score of this questionnaire is 30 and 126. The higher the score obtained from this questionnaire, the higher the quality of life and vice versa. The score that a person gets from the 8-item treatment adherence questionnaire (MMAS-8) and the range of total scores is between 0 and 8. Timepoint: It is before the start of the intervention and one month and three months after the end of the intervention. Method of measurement: The drug treatment compliance questionnaire has 8 questions and measures drug treatment compliance. MMAS-8 drug treatment compliance questionnaire includes seven two-choice questions (with yes and no answers) and one Likert-type question, and question number 5 is scored in contrast to other questions. The range of total scores is between 0 and 8. The lower the score, the more people will adhere to medication. Scoring: In questions 1 to 7, yes answers are given a score of 1 and no answers are given a zero score. Question 5 is scored in reverse. In question 8, a score of 1, sometimes a score of 0.75, usually a score of 0.5, usually a score of 0.25, and always a score of zero is given for the answer of never. Semnan University of Medical Sciences Approved 2023-03-13 Ethics committee of Semnan University of Medical Sciences headquarters of Semnan University of Medical Sciences and Health Services-Basij Blvd Semnan Semnan Iran (Islamic Republic of)