Comparison of the effectiveness of the PLISSIT model with the Sexual health model on quality of life and sexual behavior among women with breast cancer
This study is a randomized controlled clinical trial. In the study sample size is 75 women 50-20 years old, married with breast cancer who are sexually active. Subjects were randomized using a random numbers table into three groups, two experimental groups and one control group will be divided. The first group intervention model approach PILSSIT will receive counseling. The second group intervention model based sexual health Model will be to form a group. The control group, no organization would be made and the action group will receive routine. Information Demographic data questionnaire, Sexual behavior questionnaire , Quality of life questionnaire QLQ-BR 23 and QLQ-C30 ,Sexual distress questionnaire and Sexual Function questionnaire will be collected. The information collected will be analyzed by SPSS statistical tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083025431N2
Registration date:2017-10-31, 1396/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-31, 1396/08/09
Registrant information
Name
Elham Shakibazadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3210
Email address
shakib@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental( Zanjan University of Medical Sciences)
Expected recruitment start date
2016-09-04, 1395/06/14
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of the PLISSIT model with the Sexual health model on quality of life and sexual behavior among women with breast cancer
Public title
Comparison of the effectiveness of the PLISSIT model with the Sexual health model on quality of life and sexual behavior among women with breast cancer
Purpose
Other
Inclusion/Exclusion criteria
Study inclusion criteria:
1. Having a wife and sexually active individual reports
2. age between 20 and 50 years
3. Other breast cancer and non-cancer
4. Sexual Distress Scale score above 11
5. fiftieth percentile score means lower sexual behavior of women of reproductive age.
6. treatment of patients with surgery or chemotherapy or both
7. After at least 3 months of treatment,
8. do not receive formal education about sexual issues during the last 6 months
9. no history of mental illness in the past year at least
10. No drugs or alcohol
Exclusion criteria Study:
1. relapse
2. intervention during hospitalization
3. Pregnancy
4. Start the field of psychiatric medications
5. participate in therapy sessions over a meeting
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Azady square. Center of Zanjan university medical science
City
Zanjan
Postal code
Approval date
2016-08-15, 1395/05/25
Ethics committee reference number
َA_ 11-177-6
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
c50.8
ICD-10 code description
Malignant neoplasm: Overlapping lesion of breast
Primary outcomes
1
Description
sexual behavior/ quality of life
Timepoint
befor intervention/ 6 week after intervention/ 12 week after intervention
Method of measurement
DemoDemographic questionnaire, the questions related illness and treatments, native standardized questionnaire and sexual distress, sexual function questionnaire to determine the type of sexual dysfunction, native questionnaire to assess sexual behavior in women of childbearing age and quality of life questionnaire in patients with breast cancer
2
Description
sexual behavior/ quality of life
Timepoint
befor intervention/ 6 week after intervention/ 12 week after intervention
Method of measurement
Demographic questionnaire, the questions related illness and treatments, native standardized questionnaire and sexual distress, sexual function questionnaire to determine the type of sexual dysfunction, native questionnaire to assess sexual behavior in women of childbearing age and quality of life questionnaire in patients with breast cancer