Protocol summary

Study aim
Since one of the ways to improve the quality of life in cancer patients is to control the symptoms and complications caused by cancer, therefore, the investigation and management of these symptoms become very important. The purpose of this study is to investigate the effectiveness of controlling the symptoms of cancer patients in palliative care on their quality of life.
Design
This research constitutes a pre-post interventional clinical trial to be conducted on a cohort of 90 individuals diagnosed with one type of cancer.
Settings and conduct
This study will be conducted in Imam Khomeini Hospital in Tehran. Patients referring to the oncologist who have annoying symptoms related to cancer will be referred to a palliative medicine specialist through a letter. Then, based on the severity of the annoying symptoms and the physical needs of the person, a symptom control program, specific to each patient, in the form of drug interventions and also Counseling sessions for psychology, spirituality, nutrition, etc. will be available to patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a definite cancer diagnosis with the opinion of an oncologist Having a score of at least 4 in one of the annoying symptoms such as pain or other physical symptoms The patient in the final phase of the disease and with a survival of less than one month will be excluded from the study
Intervention groups
Symptom control includes managing annoying physical symptoms such as pain, digestive symptoms (nausea, vomiting, constipation, diarrhea, etc.), respiratory symptoms (shortness of breath, cough, etc.), neurological symptoms (delirium, headache, etc.) and other symptoms that will be performed in the outpatient clinic in the form of pharmacological and non-pharmacological interventions.
Main outcome variables
Severity score of common symptoms in cancer patients and their quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230408057851N1
Registration date: 2023-05-07, 1402/02/17
Registration timing: prospective

Last update: 2023-05-07, 1402/02/17
Update count: 0
Registration date
2023-05-07, 1402/02/17
Registrant information
Name
Adeleh Rezagholizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2530
Email address
adelehgholizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of symptom control in palliative care on the quality of life of cancer patients referred by oncologists
Public title
Evaluation of the effectiveness of symptom control in patients with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a definite cancer diagnosis with the opinion of an oncologist Physical and mental ability to communicate and complete questionnaires Having a score of at least 4 in one of the annoying symptoms such as pain or other physical symptoms Patient availability during the 2-week study period First referral to the palliative care service
Exclusion criteria:
The patient is in the final phase of the disease Prediction of survival of less than one month for the patient
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
مجتمع بیمارستانی امام خمینی ره- دانشگاه علوم پزشکی تهران (کمیته اخلاق در پژوهش)
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.455

Health conditions studied

1

Description of health condition studied
Advanced Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasm

Primary outcomes

1

Description
The intensity score of common symptoms experienced by cancer patients in the Edmonton Symptom Assessment Scale questionnaire
Timepoint
Time intervals for evaluation at the beginning of the study (before the cancer symptom management plan), and by passing 7, and 14 days from the intervention (Follow-up)
Method of measurement
Edmonton Symptom Assessment Scale questionnaire (ESAS)

2

Description
Quality of life in cancer patients
Timepoint
Time intervals for evaluation at the beginning of the study (before the cancer symptom management plan), and by passing 7, and 14 days from the intervention (Follow-up)
Method of measurement
The European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC-QLQ-C۳۰)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A personalized cancer symptom management plan, designed by a palliative medicine specialist, which includes pharmacological and non-pharmacological interventions (psychological, spiritual, nutritional counseling sessions, etc.) in the outpatient clinic.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Adeleh Rezagholizadeh Shirvan
Street address
Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2530
Email
adelehgholizadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Adeleh Rezagholizadeh Shirvan
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
adelehgholizadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Adeleh Rezagholizadeh Shirvan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Palliative Medicine
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
adelehgholizadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Adeleh Rezagholizade Shirvan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Palliative Medicine
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
adelehgholizadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Adeleh Rezagholizadeh Shirvan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Palliative Medicine
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2530
Email
adelehgholizadeh@gmail.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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