Objectives: Aim of this study is to determine the effect of group counseling based on problem solving therapy on sexual quality of life in patients suffering from breast cancer. Design: This study is a clinical trial in two groups. Participants: The population will be 110 randomly selected women who suffering from breast cancer in Mahdieh MRI center in Hamadan city, Iran. A sample of 55 patients in the intervention group and 55 patients in the control group will be determined. Method: Before starting the study SQOL-F questionnaire will be completed by both groups and then they will divide into intervention and control groups. The intervention group will divide into groups of 25 to 30 persons that they will participate in 6 meeting. Each meeting will last 1 to 1.5 hours. At the end of women concealing meeting, a meeting will be perform for women's husbands to give them some information. Husbands will complete SQOL-M questionnaire before and after the meeting. After that, two groups will give two months to practice the skills that have learned. After two months two groups will complete the SQOL-F questionnaire again. During the study there is no intervention on control group. However, at the end of study whole of information will be given to the control group as well. A main outcome measure is sexual quality of life in breast cancer patients. Comparison of two groups will done before and two months after intervention in term of sexual quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100910426N15
Registration date:2016-10-28, 1395/08/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-28, 1395/08/07
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling based on problem solving on sexual quality of life in patients suffering from breast cancer
Public title
The effect of group counseling based on problem solving on sexual quality of life in patients suffering from breast cancer in MRI center of Hamadan city in 2016
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 25 to 50 years old; married; living with her husband; Diagnosis of breast cancer at least 6 moths ago; being in stage I and II breast cancer; lack of participating in any counseling programs and training on breast cancer in the past; lack of undergoing chemotherapy.
Exclusion criteria: No participate in meeting more than two sessions; Severity of disease during the study; the incidence of other serious illnesses such as: heart disease, kidney, liver and mental illness during the study; existence of other factors that will effect on sexual life of patients such as: disaster and important change in the life and marital relationships such as violence and divorce during the study, using drugs that interfere with sexual activity, drug addiction and so on.
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street, Counterpoint of Mardom Park, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.UMSHA.REC.1395.320
Health conditions studied
1
Description of health condition studied
brast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
Sexual quality of life in breast cancer
Timepoint
Before and two months after intervention
Method of measurement
Sexual Quality of Life Questionnaire (SQOL-F)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:After completing consent form by participants, Two groups will complete demographic and SQOL-F questionnaires. After Completing the questionnaire, the intervention group will divide into groups of 25 to 30 persons that they will participate in 6 meeting. Each meeting will last 1 hour to 1 and half. At the end of women concealing meeting , a meeting will be perform for women's husbands to give them some information. Husbands will complete SQOL-M questionnaire before and after the meeting. After the meeting , two groups will give two month to practice the skills that have learned. After two months two groups will complete the SQOL-F questionnaire again.
Category
Other
2
Description
Control group: only receive routine cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Mahdieh M.R.I. Center
Full name of responsible person
Nazanin Kademi
Street address
Parastar Street, Pajohesh square, Hamedan Mahdieh M.R.I. Center, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Shahid Fahmideh Street, Counterpoint of Mardom Park, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Fahmide street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
65178-38698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Counterpoint of Mardom Park, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Fahmideh Street, Counterpoint of Mardom Park, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3835 0150
Fax
Email
parsa@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)