The effect of counseling based of EXPLISSIT model on the sexual function of married women with lumpectumy for Breast cancer: a randomized controlled clinical trial
Determine the impact of consultation with EXPLISSIT Model on sexual function of married women with lumpectomy of breast cancer
Design
The participants will be assigned randomly, using RAS software and blocking system of 4 and 6, in two groups of counseling and control with a 1: 1 ratio.
Settings and conduct
The researcher will refer to the Oncology Clinic of Shahid Ghazi Hospital, Nurnejat, ،Tabriz Central Cancer Clinic. Participants will receive written consent letter. The pre-test questionnaires consisted of Social-Demographic , Sexual Function Index , Sexual Satisfaction For Women and Sexual Quality of Life-Female will be completed by contributors. Women with score of 10-28 the FSFI will participate in the research. At the end, all the mentioned questionnaires will complete after 8 weeks of consultation in both group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women aged 18-45; Married women; stage1-3; FSFI score10- 28; Having a contact number for follow up;One year after lumpectomy.
Exclusion criteria: Progression or recurrence of breast cancer over the past six months, drug addiction and smoking, treat for sexual dysfunction, history of mental disorders, history of chronic diseases, other cancers of women and use of drugs affecting sexual function.
Intervention groups
Intervention group: Intervention group (31women), will receive an individual 60-90 minutes counseling according with EXPLISSIT model and further session if needed. Control group: The control group will not receive special care in relation to sexual dysfunction.
Main outcome variables
Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036615N4
Registration date:2018-04-23, 1397/02/03
Registration timing:registered_while_recruiting
Last update:2018-04-23, 1397/02/03
Update count:0
Registration date
2018-04-23, 1397/02/03
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based of EXPLISSIT model on the sexual function of married women with lumpectumy for Breast cancer: a randomized controlled clinical trial
Public title
The effect of counseling based of EXPLISSIT model on the sexual function of married women with lumpectomy for Breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Exclusion criteria; Women aged 18-45; Married women; Breast cancer in stage1-3; FSFI score10- 28; Having a contact number for follow up; One year's expiration of lumpectomy
Exclusion criteria:
Progression or recurrence of breast cancer over the past six months, drug addiction and smoking, women treated for sexual dysfunction, history of mental disorders, history of chronic and systemic diseases, other cancers of women and use of drugs affecting sexual function.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned randomly, using RAS software and blocking system of 4 and 6, in two groups of counselling and control with a 1: 1 ratio.
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 Tabriz University of Medical Sciences
Street address
South Shariati Street,Faculty of Nursing and Midwifery of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-02-13, 1396/11/24
Ethics committee reference number
IR.TBZMED.REC.1396.998
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
Sexual function
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Sexual Function Index questionnaire
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Before intervention and two months after the intervention
Method of measurement
Sexual Satisfaction questionnaires (SSSW)
2
Description
Sexual quality of life
Timepoint
Before intervention and two months after the intervention
Method of measurement
Sexual Quality of Life-Female questionnaires (SQOL-F)
Intervention groups
1
Description
The control group will receive counseling sessions on self-care
Category
Lifestyle
2
Description
Intervention group: including 60-90 minutes individual counseling and further session if needed