Determining the influence of uncertainty toleration-based intervention among couples on mental adjustment with illness in women with breast cancer who have referred to Urmia Medical Education and Research Center in 2020-2021
Design
Clinical trial with control and intervention group, with parallel groups, non-blinded, randomized, on 100 patients. An envelope containing even and odd numbers was used for randomization. Even numbers are for the control group and odd numbers are for the intervention group
Settings and conduct
Study place: Imam Khomeini Hospital, Urmia.
There is no blinding in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range of 30 -60 years; breast cancer in stage 1,2, and 3 according to pathology report; breast cancer awareness; after more than 48 hours of chemotherapy; being married and lived more than 12 months with her partner; not attending other educational sessions; having mental health. Non inclusion criteria: having other cancers or life-threatening illnesses.
Intervention groups
Intervention group: Uncertainty tolerance intervention will be done on couples in intervention group, which will include groups of 6 to 10 individuals and will be held weekly in 6 sessions, lasting 60 to 90 minutes each. The designed interventions include: helping to create the ability to tolerate ambiguous situations, improving positive beliefs about worries, cognitive avoidance and negative orientation towards the problems. To evaluate the participants, a diary will be provided for each person to record her daily behavior
Control group: The control group will not receive the any intervention. But due to ethical norms, after the intervention, one or two sessions will do for them.
Main outcome variables
Mental Adaptation to cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150125020778N21
Registration date:2020-12-13, 1399/09/23
Registration timing:retrospective
Last update:2020-12-13, 1399/09/23
Update count:0
Registration date
2020-12-13, 1399/09/23
Registrant information
Name
Fatemeh Moghaddam Tabrizi
Name of organization / entity
Uromia University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
moghaddam.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2020-02-21, 1398/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the influence of uncertainty toleration-based intervention among couples on mental adjustment with illness in women with breast cancer
Public title
The effect of intervention on couples on mental adjustment with illness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age range of 30 -60 years old
breast cancer in stage 1,2, and 3 according to pathology sheet
awareness of breast cancer in herself
after more than 48 hours of chemotherapy
being married and living more than 12 months with her partner
not attending other educational sessions
the patient and her partner should be mentally healthy i.e., not having hospitalization history in psychiatry and no history of antidepressant medicine use
Exclusion criteria:
Having other cancers
Having any life-threatening illness
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
By taking into account the inclusion criteria and getting the consent, 100 couples enter the study by availability sampling method. Using the envelope containing odd and even numbers, 50 people will be selected randomly for the control group and 50 for the intervention group.Even numbers are for the control group and odd numbers are for the intervention group
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 Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, next to the emergency center, Resalat blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
IR.UMSU.REC.1398.032
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
Mental Adaptation with cancer
Timepoint
Before intervention and 6 weeks after the first session
Method of measurement
Mental adjustment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Uncertainty tolerance intervention will be done on couples in intervention group, which will include groups of 6 to 10 with titles introduce, communicate and encourage clients to express their views on their experiences in applying methods of adjustment before, providing effective solutions and use and interpret and discuss each item of the intervention program that will be held weekly in 6 sessions, each of them lasting 60 to 90 minutes. Researcher will use tools such as flash card, PowerPoint, pamphlets, lectures and group discussion to more effective intervention program during the intervention. The designed interventions include: helping to create the ability to tolerate ambiguous situations, improving positive beliefs about worries, cognitive avoidance and negative orientation towards the problems. To evaluate the participants, a diary will be provided for each person to record her daily behavior
Category
Lifestyle
2
Description
Control group:The control group will not receive the any intervention. But due to ethical norms that they were in the control group, after the intervention, one or two sessions will do for them