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IRCT20230627058602N1 IRCT 2023-07-22 Tehran University of Medical Sciences Adaptation, feasibility, and investigation of CALM on cognitive and psychological problems of patients with advanced cancer Adaptation and Feasibility of Managing Cancer and Living Meaningfully (CALM) Intervention for Patients with Advanced Cancer in Iran: Investigating Its Cognitive and Psychological Impacts 2023-07-23 anticipated 50 Complete https://irct.ir/trial/71039 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will use simple stratified randomization with 1:1 allocation between arms. Computerized randomization will be created, administered, and password protected by a researcher at Razi University independent of the research team. After obtaining written informed consent and completing the initial steps, the research assistant contacts the center via email to receive the subject and inform the patients about the therapist they will be seeing. No member of the research team will have access to the randomization list. 2-3 Malignant solid tumor as follows: stage III B or IV lung cancer; any stage of pancreatic cancer, stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancer; and stage IV breast, genitourinary, gastrointestinal, melanoma, sarcoma, or endocrine cancers. Intervention group: Managing Cancer and Living Meaningfully (CALM) is a brief, semi structured and manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. It consists of three to six sessions, usually of 45 minutes, delivered across 3 to 6 months, and addresses 4 main domains: symptom control and communication with health care providers; changes in self and relations with close others; spiritual well-being and sense of meaning and purpose; and preparing for the future, sustaining hope, and facing mortality. The timing of sessions and content explored are guided by the patient’s interests and priorities. Interventions are adapted to patient and caregiver needs by using supportive approaches, such as education and validation, and expressive approaches, including facilitation of reflection and creation of meaning. So the therapist facilitates exploration of four broad domains, while also attuning to and helping to regulate the patient’s emotional state. Control group: They are referred to the palliative clinic to receive common treatment. Their therapeutic approach is based on an integrative approach consisting of psycho-oncological counseling, provision of information, crisis intervention as well as supportive individual therapy. As for the intervention arm, patients randomized to the control arm will receive up to six, 50-min sessions delivered over 3 months.. Yes - There is a plan to make this available What will be shared: Demographic information, excluding personally identifiable information, medical information, and primary outcome information, may be shared. Also, the information obtained from the analysis of tests and questionnaires and the result of the research will be available to those interested in the form of an article. When: The start of the access period will be after the publication of the results in the form of an article, and will be for a maximum period of one year. To whom: Researchers working in academic and scientific institutions can request to send data. Conditions: The information contained in the data will be provided to the applicant for study purposes only. Where to obtain: Applicants can send their application through the email below: nabipour.sanaz@gmail.com How to obtain: In case of request via email, they will be answered within 48 working hours. Comments:
public Sanaz Nabipour
First Flour, No. 307, Mojahedin Ave and Rahmanipour Ave Junc., Baharestan
Tehran Iran (Islamic Republic of) 1154917513 +98 21 2220 8653 nabipour.sanaz@gmail.com The University of Kharazmi scientific Alireza Moradi
No. 43, Shahid Muftah St.
Tehran Iran (Islamic Republic of) ۱۴۹۱۱۱۵۷۱۹ +98 21 8832 9220 moradi90@yahoo.com The University of Kharazmi Iran (Islamic Republic of) Fluency in Persian language Diploma or higher level of education and living in Tehran Diagnosis of the metastatic solid tumor as follows: stage III B or IV lung cancer; any stage of pancreatic cancer, stage III or IV ovarian and fallopian tube cancers, or stage IV of other gynecological cancers; and stage IV breast, genitourinary, gastrointestinal, melanoma, sarcoma, or endocrine cancers Life expectancy 12 to 18 months A score greater than or equal10 on the Patient Health Questionnaire (PHQ9) A score greater than 5 on the Post-traumatic Stress Disorder Checklist (PCL-5) A score greater than or equal to 20 on the Death and Dying Distress Scale (DADDS) A score lesser than 27 on Mini-Mental State Examination (MMSE) 18 years no limit Both Language or communication barriers hindering psychotherapy Consciousness problems or inability to participate in assessment and intervention sessions Disorder and features of acute psychosis Suicidal thoughts and attempts Severe sensorimotor disabilities Brain damage or any medical condition that better explains the cognitive and psychological problems of patients with advanced cancer Concomitant psychotherapy C00-C80 Malignant neoplasms, of specified sites, except of lymphoid, haematopoietic and related tissue Rehabilitation Intervention group: Managing Cancer and Living Meaningfully (CALM) is a brief, semi structured and manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. It consists of three to six sessions, usually of 45 minutes, delivered across 3 to 6 months, and addresses 4 main domains: symptom control and communication with health care providers; changes in self and relations with close others; spiritual well-being and sense of meaning and purpose; and preparing for the future, sustaining hope, and facing mortality. The timing of sessions and content explored are guided by the patient’s interests and priorities. Interventions are adapted to patient and caregiver needs by using supportive approaches, such as education and validation, and expressive approaches, including facilitation of reflection and creation of meaning. So the therapist facilitates exploration of four broad domains, while also attuning to and helping to regulate the patient’s emotional state. Control group: They are referred to the palliative clinic to receive common treatment. Their therapeutic approach is based on an integrative approach consisting of psycho-oncological counseling, provision of information, crisis intervention as well as supportive individual therapy. As for the intervention arm, patients randomized to the control arm will receive up to six, 50-min sessions delivered over 3 months. The score of depression symptoms in the Patient Health Questionnaire (PHQ-9). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using the Patient Health Questionnaire (PHQ-9). The score of death distress in the Death And Dying Distress Scale (DADDS). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Death And Dying Distress Scale (DADDS). The score of post-traumatic stress symptoms in Posttraumatic Stress Disorder Checklist (PCL-5). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Posttraumatic Stress Disorder Checklist (PCL-5). The quality of life score in the quality-of-life scale of patients with advanced cancer (QUAL-EC). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Quality of life scale of patients with advanced cancer (QUAL-EC). The memory score in the Prospective and Retrospective Memory Questionnaire (PRMQ). Timepoint: Before starting the intervention, the third month for evaluation and the 4th month for follow-up. Method of measurement: Using Prospective and Retrospective Memory Questionnaire (PRMQ). Tehran University of Medical Sciences Approved 2023-06-20 Research Ethics Committees of Imam Khomeini Hosp Management of Research and Technology Affairs of the University, 6th Floor, Central Building of Tehran University of Medical Sciences, Intersection of Keshavarz Blvd and Qods Street, Tehran Tehran Tehran Iran (Islamic Republic of)