Investigating of the effect of psychotherapy intervention on anxiety of gastrointestinal cancer patients and in Valiasr hospital oncology ward Zanjan in 2022
Determining the effect of group psychotherapy and support on the level of anxiety in patients with gastrointestinal cancer
Design
The present study is a randomized clinical trial study of parallel design, double-blind and with a control group, which will be performed on 50 patients with gastrointestinal cancers with anxiety referring to the oncology department of Waliasr Hospital. Then the patients will be randomly divided into two groups of intervention (N=25) and control (N=25) using the table of random numbers. For the intervention group, 6 sessions of psychotherapy will be held for 30 minutes (2 sessions per week), and for the control group, a series of trainings and routine care will take place. It should be noted that for better education and class management, intervention group patients will be divided into groups of 10 if necessary.
Settings and conduct
This study is a clinical trial study. The target group is patients over 18 years old with one of the gastrointestinal cancers who have symptoms of anxiety and depression.
The location of this research is the oncology department of Waliasr Hospital, Zanjan-1401.
Data collection tool based on demographic and clinical characteristics. The second version of Beck's anxiety questionnaire is BDI-II, which is through interviews with patients; For the intervention group, six psychotherapy sessions will be held for 30 minutes and 2 sessions per week, and there will be no intervention for the control group. Finally, the data is entered into SPSS26 software after collection.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age with one of the gastrointestinal cancers referred to the oncology department
Intervention groups
Intervention group: 6 psychotherapy sessions for 30 minutes (2 sessions per week). Control group: education and routine care.
Main outcome variables
Anxiety; Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221118056532N1
Registration date:2022-12-18, 1401/09/27
Registration timing:prospective
Last update:2022-12-18, 1401/09/27
Update count:0
Registration date
2022-12-18, 1401/09/27
Registrant information
Name
Kazem Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4001
Email address
beheshti@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating of the effect of psychotherapy intervention on anxiety of gastrointestinal cancer patients and in Valiasr hospital oncology ward Zanjan in 2022
Public title
Investigating of the effect of psychotherapy intervention on anxiety of gastrointestinal cancer patients and in Valiasr hospital oncology ward Zanjan in 2022
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
volunteering to enter the study,
Age above 18 years
Having one of the gasterointestinal cancer
Exclusion criteria:
Having diagnosed psychological illness including anxiety and depression
Participation in psychotherapy classes
death of a loved one; Divorced in the last 6 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
To use the table of random numbers, we first determine the direction of reading the numbers in the table (for example, up, down, left or right), then even numbers are considered for the intervention group and odd numbers for the control group. In the next step, the researcher puts his hand on one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups, and this should continue until the samples are assigned to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blind, so that the patients and the researcher responsible for data analysis will not have any intervention or control information regarding the allocation of people to groups. To blind the patients, we will provide a series of trainings and routine care to the control group. For the purpose of blinding the statistician who is responsible for data analysis, the intervention and control groups will be coded and provided to him for analysis without mentioning the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee of ethics in biomedical research
Street address
Ark square, Hospitalof Shahid Beheshti Educational & Treatment Center of Shahid Beheshti
City
Zanjan
Province
Zanjan
Postal code
4513615788
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.ZUMS.REC.A-12-1523-6
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
cancer
ICD-10 code
D70.1
ICD-10 code description
Agranulocytosis secondary to cancer chemotherapy
Primary outcomes
1
Description
depression
Timepoint
Before starting the study - 6 sessions
Method of measurement
BDI-II
Secondary outcomes
1
Description
Anxiety and depression score
Timepoint
Before the intervention - six sessions
Method of measurement
BDI-II,Depression questionnaire
Intervention groups
1
Description
Intervention group: will participate in 6 psychotherapy sessions for 30 to 60 minutes and 2 sessions per week. The first session: supportive psychotherapy and its importance, getting to know the principles of the group, getting to know more about the members and getting to know the disease. The second session: discussion and exchange of opinions of members about cancer and its impact on life. Session 6-3: Focus on members' concerns and problems.
Category
Behavior
2
Description
Control group: The control group will receive regular training and care during the study period.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Department of Valiasr Hospital, Zanjan
Full name of responsible person
Kazem Ashrafi
Street address
Valiasr Hospital, Valiasr square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45157-77978
Phone
+98 914 349 8738
Email
Kazemashrafi78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nedri
Street address
Arg Square, Dr. Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3315 6141
Email
Kazemashrafi78@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Kazem Ashrafi
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Arg Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
Kazemashrafi78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kazem Ashrafi
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Arg Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Email
Kazemashrafi78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kazem Ashrafi
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hospital, Arg Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
0243544001
Email
Kazemashrafi78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main message can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
People working in medical and academic institutions
Under which criteria data/document could be used
It is allowed for therapeutic and research use.
From where data/document is obtainable
People can refer to Dr. Kazem Ashrafi working at Shahid Beheshti Hospital in Zanjan for receipts.
What processes are involved for a request to access data/document
After applying to the University of Medical Sciences and obtaining permission.