Determining the effectiveness of cognitive-behavioral stress management on fear of disease progression in women with breast cancer
Design
Clinical trial with control group, randomized, on 54 patients
Random allocation using block design method (4 blocks) in two groups of intervention and control
Settings and conduct
The statistical population of women with breast cancer referred to the accelerator ward of Golestan Hospital in ahvaz.54 women with a high fear of disease progression score who meet the inclusion criteria are selected.And fall into two groups of intervention (27) and control (27).Behavioral cognitive stress management training is performed on the intervention group during 10 weekly sessions.The Fear of Progress of Hersbach's disease questionnaire is completed in two stages: pre-test and post-test.
Participants/Inclusion and exclusion criteria
Having a cancer diagnosis by a specialist
Score above 85 of the Fear of Disease Progression Questionnaire
Be literate
Willingness to participate in research
Written consent to participate in the research
Reluctance to continue participating in research
Incomplete completion of the questionnaire
Having medical disorders at the same time
Under psychotherapy simultaneously
Having serious illnesses or cancer
Having any signs of metastatic disease
Intervention groups
cognitive-behavioral therapy in 10 sessions of 90 minutes, one day a week, for the interventional group in the study . no training and advice is given in the control group
Main outcome variables
fear of disease progression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220122053798N1
Registration date:2022-02-28, 1400/12/09
Registration timing:prospective
Last update:2022-02-28, 1400/12/09
Update count:0
Registration date
2022-02-28, 1400/12/09
Registrant information
Name
Fatemeh zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3273 8397
Email address
zare.fatemeh7575@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-14, 1401/01/25
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral stress management on fear of disease progression in women with breast cancer
Public title
The effectiveness of cognitive-behavioral stress management on fear of breast cancer progression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a cancer diagnosis by a specialist
Score above 85 of the Fear of Disease Progression Questionnaire
Be literate
Willingness to participate in research
Written consent to participate in the research
Exclusion criteria:
Reluctance to continue participating in research
Incomplete completion of the questionnaire
Having medical disorders at the same time
Under psychotherapy simultaneously
Having serious illnesses or cancer
Having any signs of metastatic disease
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning individuals in control and test groups is random and quadruple blocks (using the table related to random permutations).After determining the volume of blocks, which in this study is 4, a list of blocks is prepared and a number is assigned to them.Then random numbers between 1 and 6 will be selected.(4)AABB(1) , ABAB(2),ABBA(3),BBAA
BABA(5),BAAB(6)
There will be a total of 24 opportunities for random selection.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committeee of Ahvaz University of Medical Sciences
Street address
Ahvaz University of Medical sciences, Golestan Blvd,Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.AJUMS.REC.1400.611
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Fear of disease progression score in the fear of disease progression questionnaire of Hersbach
Timepoint
Before the intervention and after the end of the intervention
Method of measurement
fear of disease progression questionnaire of Hersbach
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:For the intervention group (27 people), group stress management training (cognitive-behavioral) is done during 10 weekly sessions. each 90-minute training session will include 45 minutes of training and 45 minutes of practical work Based on Anthony, Ironson, Schneiderman's training package.Behaviorally cognitively stress management is a multifaceted approach in which techniques such as relaxation, diaphragmatic breathing, meditation, detection of negative automatic thoughts, cognitive distortions and its reconstruction by replacing logical thoughts, effective coping training, management Anger and expression are taught to people. Hersbach Fear of disease progression questionnaire is completed in two stages: pre-test and post-test
Category
Behavior
2
Description
Control group:No psychological training is applied for the control group of 27 people, but the questionnaire is administered in two stages of pre-test and post-test and together with the intervention group for the control group.