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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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History
# Registration date Revision Id
2 2023-10-08, 1402/07/16 281321
1 2023-10-04, 1402/07/12 280819
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  • General information

    2023-08-16, 1402/05/25
    2023-10-09, 1402/07/17
    2023-10-22, 1402/07/30
    2023-11-09, 1402/08/18
    empty
    Due to numerous corrections in the trial registration and prolongation of approval in IRCT, the start and end date of sampling was changed.
    empty
    به علت اصلاحات متعدد در ثبت کارآزمایی و طولانی شدن تایید در irctتاریخ شروع و پایان نمونه گیری تغییر داده شد

  • Recruitment centers

    #1
    Name of recruitment center - English: Emam Khomeini haspital.
    Name of recruitment center - Persian: بیمارستان امام خمینی
    Full name of responsible person - English: Nakisa Solymanian
    Full name of responsible person - Persian: نکیسا سلیمانیان
    Street address - English: Kheshavars Blvd,Emam Khomeini Haspital
    Street address - Persian: بلوار کشاورز, بیمارستان امام خمینی
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733141
    Phone: +98 21 6119 2233
    Fax:
    Email: mydigital.market1@gmail.com
    Web page address:
    Name of recruitment center - English: Emam Khomeini haspital.
    Name of recruitment center - Persian: بیمارستان امام خمینی
    Full name of responsible person - English: Nakisa Solymanian
    Full name of responsible person - Persian: نکیسا سلیمانیان
    Street address - English: Emam Khomeini Hospital, Kheshavars Blvd.
    Street address - Persian: بلوار کشاورز, بیمارستان امام خمینی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733141
    Phone: +98 21 6119 2233
    Fax:
    Email: mydigital.market1@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akbar Foutohi
    Full name of responsible person - Persian: اکبر فتوحی
    Street address - English: Kheshavars Blvd , Emam Khomeini Haspital
    Street address - Persian: بلوار کشاورز بیمارستان امام خمینی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733141
    Phone: +98 21 6119 2233
    Fax:
    Email: mydigital.market1@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akbar Foutohi
    Full name of responsible person - Persian: اکبر فتوحی
    Street address - English: The central organization of the university ,Qods St., Kheshavars Blvd.
    Street address - Persian: بلوار کشاورز خیابان قدس سازمان مرکزی دانشگاه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733141
    Phone: +98 21 8899 2970
    Fax:
    Email: afotouhi@tums.ac.ir
    Web page address:

Protocol summary

Study aim
The effect of supportive palliative medicine treatment on the symptoms of terminally ill cancer patients in Imam Khomeini Hospital
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 15 patients. The rand function of Excel software was used for randomization.
Settings and conduct
A clinical trial is conducted at Imam Khomeini Hospital, who refer to the palliative medicine clin
Participants/Inclusion and exclusion criteria
The entry conditions of cancer patients in the final stages and the non-entry of cancer patients who receive specific treatments for the disease.
Intervention groups
The intervention in the control group is not receiving psychotherapy and in the intervention group psychotherapy.
Main outcome variables
Wasting the patient's time to fill out the questionnaire

General information

Reason for update
Due to numerous corrections in the trial registration and prolongation of approval in IRCT, the start and end date of sampling was changed.
Acronym
IRCT registration information
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
Registration date
2023-10-04, 1402/07/12
Registrant information
Name
Nakisa Soleymanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 169 3774
Email address
mydigital.market1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-09, 1402/07/17
Expected recruitment end date
2023-11-09, 1402/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of palliative care supportive treatment on the symptoms of cancer patients in the final stage 2022-2023
Public title
Investigating the effect of palliative medicine on the symptoms of cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients who refer to the palliative medicine clinic do not know about the patients who refer to the internal clinic
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Emam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.041

Health conditions studied

1

Description of health condition studied
End stage cancer
ICD-10 code
Z85.8
ICD-10 code description
Personal history of malignant neoplasms of other organs and systems

Primary outcomes

1

Description
Questionnaire of sleep quality, appetite and depression
Timepoint
Filling out the questionnaire at the first visit and then four weeks later.
Method of measurement
Questionnaire for the effect of supportive treatments on patients' symptoms

2

Description
appetite
Timepoint
sleep
Method of measurement
depression

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini haspital.
Full name of responsible person
Nakisa Solymanian
Street address
Emam Khomeini Hospital, Kheshavars Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2233
Email
mydigital.market1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Foutohi
Street address
The central organization of the university ,Qods St., Kheshavars Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nakisa Solymanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Khomeini Hospital, Kheshavars Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
0098 21 61190
Email
mydigital.market1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nakisa Solymanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Khomeini Hospital, Kheshavars Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
0098 21 61190
Email
mydigital.market1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nakisa Solymanian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Khomeini Hospital, Kheshavars Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
0098 21 61190
Email
fsalehinik@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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