Protocol summary
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Study aim
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The effect of supportive palliative medicine treatment on the symptoms of terminally ill cancer patients in Imam Khomeini Hospital
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Design
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Clinical trial with control group, with parallel groups, single-blind, randomized, on 15 patients. The rand function of Excel software was used for randomization.
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Settings and conduct
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A clinical trial is conducted at Imam Khomeini Hospital, who refer to the palliative medicine clin
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Participants/Inclusion and exclusion criteria
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The entry conditions of cancer patients in the final stages and the non-entry of cancer patients who receive specific treatments for the disease.
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Intervention groups
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The intervention in the control group is not receiving psychotherapy and in the intervention group psychotherapy.
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Main outcome variables
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Wasting the patient's time to fill out the questionnaire
General information
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Reason for update
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Due to numerous corrections in the trial registration and prolongation of approval in IRCT, the start and end date of sampling was changed.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230528058320N1
Registration date:
2023-10-04, 1402/07/12
Registration timing:
prospective
Last update:
2023-10-09, 1402/07/17
Update count:
1
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Registration date
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2023-10-04, 1402/07/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-10-09, 1402/07/17
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Expected recruitment end date
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2023-11-09, 1402/08/18
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the impact of palliative care supportive treatment on the symptoms of cancer patients in the final stage 2022-2023
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Public title
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Investigating the effect of palliative medicine on the symptoms of cancer patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
All patients in the final stages of cancer
End-stage cancer patients referred to palliative medicine clinic of Imam Khomeini Hospital
All patients in the final stages of hematological cancers
All cancer patients who do not receive special cancer treatment
End-stage cancer patients referred to internal clinic of Imam Khomeini Hospital
Exclusion criteria:
Patients receiving specific cancer treatment
Cancer patients who visit the surgery clinic
Cancer patients receiving chemotherapy
Cancer patients candidates for surgery
Cancer patients candidates for radiotherapy
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
15
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Questionnaires are given to people randomly with the help of a random number table in the internal clinic, and in the same way, the questionnaire is given in the palliative medicine clinic.
The people of the two study groups do not know about the other group
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The patients who refer to the palliative medicine clinic do not know about the patients who refer to the internal clinic
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-09, 1402/02/19
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1402.041
Health conditions studied
1
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Description of health condition studied
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End stage cancer
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ICD-10 code
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Z85.8
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ICD-10 code description
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Personal history of malignant neoplasms of other organs and systems
Primary outcomes
1
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Description
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Questionnaire of sleep quality, appetite and depression
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Timepoint
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Filling out the questionnaire at the first visit and then four weeks later.
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Method of measurement
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Questionnaire for the effect of supportive treatments on patients' symptoms
2
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Description
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appetite
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Timepoint
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sleep
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Method of measurement
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depression
Intervention groups
1
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Description
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Intervention group: The intervention includes psychotherapy and the patient's conversation with the doctor and creating empathy during a ten-minute session and symptomatic treatment according to the patient's complaints, including constipation or diarrhea or weakness and fatigue or feelings of hopelessness and sleep problems.
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Category
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Treatment - Other
2
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Description
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Control group: This group goes to the internal clinic due to physical problems and receives the desired treatment according to the complaint, but the psychotherapy session and the patient's mental problems are not discussed.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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80
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available