Effect of counseling intervention based on good enough sex (GES) model versus control group on the sexual self-esteem and the sexual quality of life among breast cancer survivors: a randomized clinical trial
To assess the effect of counseling intervention based on good enough sex (GES) model versus control group on the sexual self-esteem and the sexual quality of life among breast cancer survivors
Design
This is a randomized clinical trial with a control group, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Mahdieh Diagnostic and Treatment Center in Hamadan city, involving 100 eligible breast cancer survivors. The patients will be randomly assigned to the intervention and control groups through the block randomization. It should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 49 years
Married women
Definitive diagnosis of breast cancer
At least 6 months and a maximum of 5 years have passed since the treatment
Being literate
Being a Persian speaker
Exclusion criteria:
Pregnancy or breastfeeding
History of participation in sex counseling sessions
Psychological or cognitive problems
Blindness or deafness
Intervention groups
Intervention group:
Routine care plus 60-90-minute counseling sessions with the Good Enough Sex (GES) approach weekly for 4 weeks
Control group:
Just routine care
Main outcome variables
Primary outcome:
Sexual self-esteem
Sexual quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N482
Registration date:2023-08-30, 1402/06/08
Registration timing:prospective
Last update:2023-08-30, 1402/06/08
Update count:0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling intervention based on good enough sex (GES) model versus control group on the sexual self-esteem and the sexual quality of life among breast cancer survivors: a randomized clinical trial
Public title
Effect of counseling intervention based on good enough sex (GES) model versus control group on the sexual self-esteem and the sexual quality of life among breast cancer survivors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 49 years
Married women
Definitive diagnosis of breast cancer
At least 6 months and a maximum of 5 years have passed since the treatment
Being literate
Being a Persian speaker
Exclusion criteria:
Pregnancy or breastfeeding
History of participation in sex counseling sessions
Psychological or cognitive problems
Blindness or deafness
Age
From 18 years old to 49 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
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.UMSHA.REC.1402.409
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 self-esteem
Timepoint
Before the intervention and 2 months later
Method of measurement
Using Sexual Self-Esteem Inventory- Women (SSEI-W)
2
Description
Sexual quality of life
Timepoint
Before the intervention and 2 months later
Method of measurement
Using Sexual Quality of Life-Female (SQOL-F) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus 60-90-minute counseling sessions with the Good Enough Sex (GES) approach weekly for 4 weeks (including: getting to know the anatomy of the body, the reproductive cycle, the importance of sex, the quality of sex, satisfaction and sexual performance, expectations in sex , correction of false beliefs and superstitions about sexual intercourse, the effect of breast cancer and mastectomy on sexual function, nutritional recommendations, sleep hygiene, body examination and conscious attention to different parts of the body, duration of sexual stimulation, enjoying sex , communication skills , skills to create and maintain intimacy)
Category
Treatment - Other
2
Description
Control group: Just routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Diagnostic and Treatment Center in Hamadan city
Full name of responsible person
Samaneh Goudarz
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Samaneh.goudarz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Samaneh Goudarz
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azita.tizno@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Azita Tiznobaik
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azita.tizno@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available