Investigating the effectiveness of treatment based on acceptance and commitment on tolerance of failure and fear of disease worsening in gastrointestinal cancer patients with stoma in Zahedan
Determining the effect of treatment based on acceptance and commitment on tolerance of failure and fear of disease worsening in gastrointestinal cancer patients with stoma in Zahedan
Design
Clinical trial with control group, with parallel groups, one-sided blind, randomized, on 40 patients.
Settings and conduct
Colorectal cancer patients with stoma will be selected from hospital departments and private practices and intervention will be performed on them
Participants/Inclusion and exclusion criteria
1) The patient is suffering from gastrointestinal cancers and will receive stoma treatment.
2) He has not participated in stoma care training courses.
3) A member of the patient's family should not be part of the treatment staff.
4) The patient is not from the treatment staff.
5) The patient is not supported by the country's stoma association.
6) At least one month has passed since his ostomy surgery.
7) Do not have speech or hearing and vision impairment.
8) Also, in addition to other patients with temporary and permanent stoma (for any reason), patients with stoma due to grade 1 and 2 cancer will also be included in the study
Intervention groups
Therapy based on acceptance and commitment is a part of the third wave of behavioral therapies, and it emerged after the second wave of these therapies, such as cognitive behavioral therapy. In ACT, the main goal is to create mental flexibility; It means creating the ability to choose a practice among different options that is more appropriate, not that a practice is done or imposed on a person simply to avoid disturbing thoughts, feelings, memories or tendencies.
Main outcome variables
Carrying failure and fear of worsening the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231120060120N3
Registration date:2024-07-20, 1403/04/30
Registration timing:prospective
Last update:2024-07-20, 1403/04/30
Update count:0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Mahla Dahmardeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 6610
Email address
mahla.dahmardeh.nurse1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of treatment based on acceptance and commitment on tolerance of failure and fear of disease worsening in gastrointestinal cancer patients with stoma in Zahedan
Public title
The effect of treatment based on acceptance and commitment on tolerance of failure and fear of disease worsening in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is suffering from gastrointestinal cancers and will receive stoma treatment
He has not participated in stoma care training courses
A member of the patient's family should not be part of the treatment staff
The patient is not from the treatment staff
he patient is not supported by the country's stoma association
At least one month has passed since his ostomy surgery
Do not have speech or hearing and vision impairment
Also, in addition to other patients with temporary and permanent stoma (for any reason), patients with stoma due to grade 1 and 2 cancer will also be included in the study
Exclusion criteria:
Aggravation of the disease that leads to hospitalization of the patient
Unwillingness to participate or continue to participate in the research
Age
From 18 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher will be present at the bedside of the patients, will explain to them the purpose of the study, and the informed consent form will be completed by the patients to participate in the study, but the people in the intervention and control groups will not know which group they will be in. Both groups will receive routine ward care.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Approval date
2024-05-19, 1403/02/30
Ethics committee reference number
IR.ZAUMS.REC.1403.084
Health conditions studied
1
Description of health condition studied
Colorectal Cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
Tolerance of Failure
Timepoint
Measurement at the beginning of the study and 3 months after the start of the intervention
Method of measurement
Harrington Failure Tolerance Questionnaire
2
Description
Fear of Disease progression
Timepoint
Measurement at the beginning of the study and 3 months after the start of the intervention
Method of measurement
Fear of Disease progression Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The receiving group of the Treatment Program based on Acceptance and Commitment
Category
Lifestyle
2
Description
Control group: The group receiving routine care and training in the inpatient department
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital, Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 993 706 8022
Email
haniedahmardeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
haniedahmardeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
haniedahmardeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
haniedahmardeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
haniedahmardeh@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
Due to the confidentiality of information and maintaining the principle of confidentiality
Study Protocol
Yes - There is 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
The data will be analyzed and the results will be presented in the article.
When the data will become available and for how long
Since 2024
To whom data/document is available
The data will be presented in the form of results in the article and researchers can access it
Under which criteria data/document could be used
The data will be presented in the form of results in the article and researchers can access it
From where data/document is obtainable
By sending an email to Mehla Dehmardeh, mahla.dahmardeh.nurse1999@gmail.com
What processes are involved for a request to access data/document