This study is experimental with pre-test and post-test randomly. The aim is to determine the effect of counseling on sex sexual quality of life of women with breast cancer are under study population of 120 women with breast cancer patients Cancer Center of Sari. Put the consent form to participate in the study volunteers who are selected to participate in the study by simple random sampling. Done to them by initial screening criteria for inclusion and exclusion based on sexual evaluation Askvvr and Beck Depression Inventory and sexual function questionnaire (FSFI). They then selected 120 patients completed questionnaires for demographic information and clinical, sexual satisfaction (ISS) and sexual quality of life questionnaire (SQOL.F). In order to impress sexual function, sexual pleasure and sexual quality of life of patients counseling is designed to attach content in four 75-minute sessions. Then there will be follow-up four weeks after the intervention to assess the impact of consultations. Is a researcher in the experimental group linked via a phone call.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060528278N1
Registration date:2016-06-28, 1395/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-28, 1395/04/08
Registrant information
Name
shakiba fatehi abdolmaleki
Name of organization / entity
University of Medical Sciences Shahroud
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 3476
Email address
shakiba.fatehi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vico Chanellor for research Shahroud University of Medical Sciences .
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of psychosexual counselling on the quality of sexual life of women with breast cancer
Public title
Effect of psychosexual counselling on the quality of sexual life of women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• a history of breast cancer
• traverse at least 6 months and a maximum of 3 years from completion of chemotherapy and chemotherapy (except hormonal therapy)
• Having at least one type of sexual dysfunction using a classification based on the FSFI and DSM5
• sexually active before cancer
• No drugs or drug addiction couples
Excluding criteria:
• Having heart disease - cardiovascular, diabetes, asthma and other chronic diseases
• The use of drugs affecting sexual activity
• history of malignancy other the
• participation in educational programs, counseling and sex
• psychological disorders such as depression
Age
From 15 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Are randomized in this study using a random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee Of Shahroud University of Medical Sciences
Street address
Hafte-Tir Square Shahroud Shahroud University of Medical Sciences
City
shahroud
Postal code
3614773955
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
ir.shmu.rec.1394.115
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C44.5
ICD-10 code description
C44.5 Skin of trunk
Primary outcomes
1
Description
Sexual quality of life
Timepoint
Before the intervention, one month after the intervention.
Method of measurement
Sexual Quality of Life Questionnaire
Secondary outcomes
1
Description
Sexual Function
Timepoint
Before the intervention, one month after the intervention.
Method of measurement
Sexual Function Questionnaire
2
Description
Sexual Satisfaction
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Sexual satisfaction questionnaires
Intervention groups
1
Description
Intervention runs in the plan based on needs assessment and on the basis of sexual schover Administrative Template psychosexual counselling.and checked recent information on past medical history. Askvvr model is merely a tool for qualitative screening is that screening clinical samples. Then, using the FSFI questionnaires and entered the realm of the six samples are screened based on the type of sexual dysfunction DSM5 (ADHD interest / sexual arousal, orgasmic disorders and impaired entry / genital-pelvic pain). Then in the same groups are using this screening tool sub-groups, namely people who have similar sexual dysfunction. In order to impress sexual function, sexual pleasure and sexual quality of life of patients is designed with the content of counseling sessions: the first session (of male and female genitalia and sexual cycle)
Session II (impact of breast cancer on sexuality)
Third session (the impact of breast cancer on sexuality)
Fourth session (interventions)
In the four 75-minute sessions. Then there will be follow-up four weeks after the intervention to assess the impact of consultations. In the meantime, a researcher with groups linked via a phone call. At the end of four weeks will test and control groups of sexual quality of life questionnaire, completed function and sexual satisfaction.
Category
Other
2
Description
The control group will follow after a counseling session
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Cancer Center of Mazandaran (Sari)
Full name of responsible person
Shakiba Fatehi Abdolmaleli
Street address
Sari Street Salman Farsi streets in paradise Basir first floor apartment unit 2
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanellor for Research of Shahroud University of Medical Sciences
Full name of responsible person
Mohamad Hasan Emamiyan
Street address
Hafte-Tir Square Shahroud Shahroud University of Medical Sciences
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanellor for Research of Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Medical Sciences Shahroud
Full name of responsible person
Shakiba Fatehi Abdolmaleki
Position
MSc Student in midwifery counseling
Other areas of specialty/work
Street address
Sari Street Salman Farsi streets in paradise Basir first floor apartment unit 2