General purpose:
Determining the impact of teaching coping strategies on the fear of relapse in patients
Specific and practical goals:
1- Determining the effect of teaching coping strategies on the level of fear of disease recurrence in patients
2- Determining the impact of teaching coping strategies on the problem solving skills of patients
3- Determining the improvement of coping strategies when faced with similar stressful conditions after receiving educational intervention in patients
4- Determining the impact of coping strategies on patients' ability to use social support
5- Determining impact of coping strategies on controlling negative emotions
Design
From among the patients referred to Shariati Hospital, according to the specificity of the sample and Cochran's formula, 55people were selected by available and sampling method.
Settings and conduct
In the pre-test phase, fear of recurrence questionnaires and coping strategies questionnaires were completed by the subjects and after the results of the training program were obtained in 8 90-minute sessions based on the theory of Folkman and Lazarus on the definition of stress and its dimensions, the types of coping styles were explained. The five steps of problem solving, dealing with negative emotions, relaxation technique, use of support systems and self-control training are discussed. Then, the tests will be conducted again in two phases: post-test and follow-up. This study will be conducted in Shariati Hospital.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include age between 30 and 45years
Awareness of the disease and its conditions
Chronic leukemia
Exit criteria Lack of knowledge about disease Other types of cancer
Intervention groups
The design of this research is per-test - post-test of one group and follow-up
Main outcome variables
Fear of Recurrence of disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N28
Registration date:2022-12-31, 1401/10/10
Registration timing:registered_while_recruiting
Last update:2022-12-31, 1401/10/10
Update count:0
Registration date
2022-12-31, 1401/10/10
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of coping strategy training on fear of recurrence in patient with Leukemia
Public title
The effectiveness of coping skills training on fear of recurrence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Receive diagnosis of chronic cancer(A.M.L)
Awareness of the disease and its conditions
Age between 30 and 45years
higher than High school diploma
Receive medical treatment
Participating in training sessions and practicing
Proficiency in Persian language
Exclusion criteria:
More than 45years old
diagnose Other types of cancer
Failure to participate in training sessions
Education less than diploma
Lack of proficiency in Persian language
Failure to receive medical treatment
Lack of knowledge about the disease and its conditions
Age
From 30 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
55
More than 1 sample in each individual
Number of samples in each individual:
55
Between 30 and 45years. Awareness of the disease and its conditions. High school diploma. Chronic CLL cancer
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, after the post-test phase, a follow-up phase is conducted using questionnaires with a gap of one month. Before the training, in order to determine the coping strategies of the participants in the study, the coping strategies questionnaire will be completed by the patients. to be added to the training plan based on The coping strategies training program is designed based on the cognitive-behavioral approach and the theory of Folkman and Lazarus in eight sessions for 90 minutes. In this program, problem solving styles, social support, and dealing with negative emotions are taught. In the first meeting, members are introduced and familiarized, the rules of the group are discussed (participation on time and active presence in the meetings and doing homework outside the group). The second session will discuss the definition of stress and identify its dimensions, the third session will be presented on various coping styles of education. In fact, problem-oriented coping styles (seeking more information about the problem, cognitively changing the structure of the problem), emotion-oriented (dealing with fault-finding behaviors, being nervous and upset, mental preoccupation and fantasizing (and avoidance) include behaviors such as coming to society) is explained. The fourth session of problem-solving skills will be taught, and in this session, things like the five steps of problem-solving (problem definition, accurate analysis of anxiety-provoking situations, list of solutions) will be mentioned. In the fifth session: Dealing with negative emotions by teaching how to control the body and teaching relaxation. In the sixth session, teaching how to use support systems including (how to get emotional support, teaching how to get emotional support, teaching how to get practical support, teaching how to get informational support, recommending to use the help of experts) and teaching self-control in the seventh session which includes things (comparing the characteristics of people with external and internal sources of control, teaching self-control or self-management skills, teaching control of behavior and emotions through role playing in the eighth session, as well as summarizing and concluding the materials and teachings presented in the previous sessions which includes (transferring the experience to real life, evaluation of the course by the participants)..The coping strategies training program is designed based on the cognitive-behavioral approach and the theory of Folk man and Lazarus in eight sessions for 90 minutes. In this program, problem solving styles, social support, and dealing with negative emotions are taught. In the first meeting, members are introduced and familiarized, the rules of the group are discussed (participation on time and active presence in the meetings and doing homework outside the group). The second session will discuss the definition of stress and identify its dimensions, the third session will be presented on various coping styles of education. In fact, problem-oriented coping styles (seeking more information about the problem, cognitively changing the structure of the problem), emotion-oriented (dealing with fault-finding behaviors, being nervous and upset, mental preoccupation and fantasizing (and avoidance) include behaviors such as coming to society) is explained. The fourth session of problem-solving skills will be taught, and in this session, things like the five steps of problem-solving (problem definition, accurate analysis of anxiety-provoking situations, list of solutions) will be mentioned. In the fifth session: Dealing with negative emotions by teaching how to control the body and teaching relaxation. In the sixth session, teaching how to use support systems including (how to get emotional support, teaching how to get emotional support, teaching how to get practical support, teaching how to get informational support, recommending to use the help of experts) and teaching self-control in the seventh session which includes things (comparing the characteristics of people with external and internal sources of control, teaching self-control or self-management skills, teaching control of behavior and emotions through role playing in the eighth session, as well as summarizing and concluding the materials and teachings presented in the previous sessions which includes (transferring the experience to real life, evaluation of the course by the participants).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research Ethics commities of research institute for Oncology, Hematology and cell therapy/ tehran un
Street address
13th floor,Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Educationbetween South Flamek and Zarafshan, Simai Iran s.t , Quds town (west),
City
tehran
Province
Tehran
Postal code
33336-94139
Approval date
2022-08-17, 1401/05/26
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1401.014
Health conditions studied
1
Description of health condition studied
Chronic leukemia (C.L.L/C.M.L)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
coping strategy
Timepoint
Pr-test and post-training. Follow-up stage
Method of measurement
Coping Action Preference Questionnaire (COPE) by Carver et al
2
Description
Fear of relapse
Timepoint
Pr-test and post-training. Follow-up stage
Method of measurement
Questionnaire of fear of recurrence Simard et al
Secondary outcomes
1
Description
fear of recurrence
Timepoint
In the pre-test stage, using Simard's Fear of Recurrence Questionnaire, then receiving 8/ 90-minute sessions of coping strategies training based on Folkman and Lazarus' theory, with an emphasis on teaching problem-solving styles, social support, dealing with negative emotions, again in the post-test stage of this The test is repeated to determine the effectiveness of coping strategies training on this variable. A month later, in the follow-up phase, this test will be performed again to measure the continuity of the training received by the patients.
Method of measurement
Simard's Fear of Recurrence Questionnaire
2
Description
Coping strategies
Timepoint
Pre-test, post-test and follow-up
Method of measurement
cope operations preference equerry
Intervention groups
1
Description
Intervention group:
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شریعتی تهران
Full name of responsible person
Dr. Mohammad Vaezi
Street address
, North Kargar St., Jalal Al Ahmad Street, in front of the Faculty of Economics, Dr. Shariati's Medical Research and Training Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
D.R Mohammad Vaezi
Street address
Shariati hospital , North kargar Ave
City
TEHRAN
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Email
vaezi.mohammad@yahoo.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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leyla sharifi Aliabadi
Position
researcher assistant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shariati Hospital , north of Kargar S.T
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
ctu@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morvarid ilkhani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mirdamad S.t , Tabrizian S.t
City
Tehran
Province
Tehran
Postal code
1919953969
Phone
+98 21 2225 9115
Email
Milkhani91@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morvarid Ilkhani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mirdamad S.t , Tabrizian S.t
City
Tehran
Province
Tehran
Postal code
1919953969
Phone
+98 21 2225 9115
Email
Milkhani91@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Regarding the coping strategies training protocol, we will explain the full description of the sessions along with the goals and tasks presented to the patients in the article.
When the data will become available and for how long
First, the pre-test stage is performed by implementing two questionnaires of coping strategies and fear of disease recurrence, then intervention is done on the patients based on the results of the questionnaires and the educational protocol. Then, the post-test phase will be done by completing the questionnaires again by the participants, after that, the follow-up phase will be done with an interval of one month. Then the data is collected and analyzed in SPSS software. The whole process takes about 4 months.
To whom data/document is available
Professors and researchers who intend to use the data for their further studies.
Under which criteria data/document could be used
Professors and researchers who intend to use the data for their further studies.
From where data/document is obtainable
Data Center of Blood, Hematology and Tuberculosis Research Center of Shariati Hospital
What processes are involved for a request to access data/document
The data with descriptive and inferential statistics of the analysis and its results will be published in the form of an article.