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IRCT20240313061275N1 IRCT 2024-04-12 Tehran University of Medical Sciences Effect of family participatory dignity therapy on the some psychological outcomes of family caregivers and patients with gastrointestinal cancers undergoing chemotherapy Effect of family participatory dignity therapy on the some psychological outcomes of family caregivers and patients with gastrointestinal cancers undergoing chemotherapy 2024-05-21 anticipated 148 Complete https://irct.ir/trial/76002 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: Blinding will be done for data analysts. N/A سرطان های گوارشی. Intervention 1: Intervention group: In order to implement family participatory dignity therapy, four sessions of 45-60 minutes will be considered. The patient and the patient's companion are present in the sessions at the same time. In the first session, the researcher will introduce dignity therapy with family participation to the patient-family couples and will receive their written informed consent. Also, the optimal time and place will be planned according to the patient's condition and the family caregiver's schedule. In the second session, that is, 24 to 48 hours later, two or three interviews, which are adjusted to the needs of the participants, will be conducted based on the framework of questions of the family participatory dignity therapy method and will be recorded using a digital audio recorder. The therapist also facilitates conversations, disclosure of real feelings and concerns, and encourages caregivers to think positively. In the third session, the interview will be transcribed verbatim and cleaned by the therapist to obtain a coherent text using an editing process. In this stage, the therapist reads the text to the patient and his companion and asks them to express the parts that need to be corrected. It will be collected from virtual space software, and at the end of this stage, the therapist will check that the edited text matches the participants' statements. In the final session, the final and edited product will be provided to the participants and it will be read in full by the therapist, the patient and the patient's companion, and the participants' opinion will be asked about the final product. In this meeting, the patient and the family can share the final product, which includes the images sent and the texts expressed, with anyone who wishes. After the intervention, the questionnaires mentioned above will be completed again one month after the completion of the treatment for the intervention group. During the study period, the control group will receive the center's routine treatments.The content of the meetingsThe main activity in family-centered participatory dignity therapy intervention is that the patient's couple and family talk about the important incidents and events in the patient's life, and finally the stated items are rewritten and given to friends and acquaintances. The patient and family can share the final version of the retold memories with friends and acquaintances. In this intervention, education is not given to the patient, and the patient himself has an active and main role in this intervention, and by doing it, the focus of the patient and the family is focused on the previous life activities and important events in the patient's life. By remembering and sharing the bright and important points of life, the patient will find a sense of purpose in life.Session 1: Introduction to family participatory dignity therapy The therapist introduces the method to the patient-family pairs and receives their written informed consent: in this part, the activities that will be performed in this intervention are fully explained to the patient and family, which include 1- Interview sessions (in which the patient's memories and past activities are asked in these sessions) 2- Sessions related to reviewing the expressed memories and correcting them 3- Session to share the final file with friends and acquaintancesThe questions of patients and their families are answeredThe optimal time of the interviews is planned according to the patient's condition and the family caregiver's scheduleSession 2: InterviewsQuestions related to family participatory dignity therapy are asked to patients and their families, which can be asked to family and patient couples in two or three interviews according to the conditions of the participants.(Questions related to the intervention are given in full in the attached files)Questions and answers of patients and family members are recorded with a tape recorderSession 3: Examining transcripts and collecting imagesThe recorded audio files have been fully transcribed and in this session the transcribed files will be shown to the patient and the caregiver, and the patient and the caregiver will identify the parts that need to be corrected by reading the file and checking it.Collecting photos: The patient and the caregiver are asked to provide the researcher with the photos and images related to the memories expressed in the previous session. Photos that evoke memories for family members and patients are collected by virtual space softwareSession 4: SharingThe final electronic file and product (which includes the collected memories and photos) can be shared with anyone the patient-family couple wishes.At this stage, the file and the final product are read by the patient couple and family and their opinion is asked about it. Intervention 2: Control group: The patients of the control group receive the usual care of the hospital and their caregivers do not receive any intervention. 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 Uncertainty of the result
public Pegah Matouypour
Tohid Square, Dr. Mirkhani St. (East Nusrat), Tehran Town
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 matourypour@yahoo.com Tehran University of Medical Sciences scientific Pegah Matouypour
Tohid Square, Dr. Mirkhani St. (East Nusrat), Tehran Town
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 matourypour@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Having a medical file with the diagnosis of gastrointestinal cancers, confirmed by the attending physician Age range from 18 to 65 years Listening, speaking and writing ability to participate in the study Being aware of the disease and being interested in participating in the study Not having cognitive impairment The presence of a caregiver next to the patient during hospitalization 18 years 65 years Both C26.9 Malignant neoplasm: Ill-defined sites within the digestive system Other Other Intervention group: In order to implement family participatory dignity therapy, four sessions of 45-60 minutes will be considered. The patient and the patient's companion are present in the sessions at the same time. In the first session, the researcher will introduce dignity therapy with family participation to the patient-family couples and will receive their written informed consent. Also, the optimal time and place will be planned according to the patient's condition and the family caregiver's schedule. In the second session, that is, 24 to 48 hours later, two or three interviews, which are adjusted to the needs of the participants, will be conducted based on the framework of questions of the family participatory dignity therapy method and will be recorded using a digital audio recorder. The therapist also facilitates conversations, disclosure of real feelings and concerns, and encourages caregivers to think positively. In the third session, the interview will be transcribed verbatim and cleaned by the therapist to obtain a coherent text using an editing process. In this stage, the therapist reads the text to the patient and his companion and asks them to express the parts that need to be corrected. It will be collected from virtual space software, and at the end of this stage, the therapist will check that the edited text matches the participants' statements. In the final session, the final and edited product will be provided to the participants and it will be read in full by the therapist, the patient and the patient's companion, and the participants' opinion will be asked about the final product. In this meeting, the patient and the family can share the final product, which includes the images sent and the texts expressed, with anyone who wishes. After the intervention, the questionnaires mentioned above will be completed again one month after the completion of the treatment for the intervention group. During the study period, the control group will receive the center's routine treatments.The content of the meetingsThe main activity in family-centered participatory dignity therapy intervention is that the patient's couple and family talk about the important incidents and events in the patient's life, and finally the stated items are rewritten and given to friends and acquaintances. The patient and family can share the final version of the retold memories with friends and acquaintances. In this intervention, education is not given to the patient, and the patient himself has an active and main role in this intervention, and by doing it, the focus of the patient and the family is focused on the previous life activities and important events in the patient's life. By remembering and sharing the bright and important points of life, the patient will find a sense of purpose in life.Session 1: Introduction to family participatory dignity therapy The therapist introduces the method to the patient-family pairs and receives their written informed consent: in this part, the activities that will be performed in this intervention are fully explained to the patient and family, which include 1- Interview sessions (in which the patient's memories and past activities are asked in these sessions) 2- Sessions related to reviewing the expressed memories and correcting them 3- Session to share the final file with friends and acquaintancesThe questions of patients and their families are answeredThe optimal time of the interviews is planned according to the patient's condition and the family caregiver's scheduleSession 2: InterviewsQuestions related to family participatory dignity therapy are asked to patients and their families, which can be asked to family and patient couples in two or three interviews according to the conditions of the participants.(Questions related to the intervention are given in full in the attached files)Questions and answers of patients and family members are recorded with a tape recorderSession 3: Examining transcripts and collecting imagesThe recorded audio files have been fully transcribed and in this session the transcribed files will be shown to the patient and the caregiver, and the patient and the caregiver will identify the parts that need to be corrected by reading the file and checking it.Collecting photos: The patient and the caregiver are asked to provide the researcher with the photos and images related to the memories expressed in the previous session. Photos that evoke memories for family members and patients are collected by virtual space softwareSession 4: SharingThe final electronic file and product (which includes the collected memories and photos) can be shared with anyone the patient-family couple wishes.At this stage, the file and the final product are read by the patient couple and family and their opinion is asked about it Control group: The patients of the control group receive the usual care of the hospital and their caregivers do not receive any intervention Depression score in Beck questionnaire. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Beck's standard depression questionnaire, second version (BDI-II). Hope score in Snyder 12-item hope questionnaire. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Snyder 12-item hope questionnaire. Psychological distress score in Kessler questionnaire. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Kessler psychological distress questionnaire. The score of family adaptation and cohesion in Elson et al.'s questionnaire. Timepoint: Before the intervention and one month after the intervention. Method of measurement: family adaptation and cohesion Elson et al.'s questionnaire. Tehran University of Medical Sciences Approved 2024-03-10 Ethics committee of Tehran University of Medical Sciences Tohid square- Nursing & Midwifery faculty Tehran Tehran Iran (Islamic Republic of)