improving sexual function in breast cancer survivors
Design
this is a quasi experimental study with control group. intervention groups include 30 participants in educational intervention group and 30 individuals in control group (without education).
Settings and conduct
Participants will be selected from the places that survivors are accessible like Cancer Research Center of Shohadaye-Tajrish hospital and their place of natural and rel life.In this way, sexual health classes will be announced in the cancer research center and through virtual media. Then we will invited who are interested for participating in our 4 session classes. FSFI-BC questionnaire will be completed for participants before intervention and again 1 week after the end of last educational session . This questionnaire will be completed for control group in those times too. The control group will be selected with the same criteria and from the attendances of cancer research center.
Participants/Inclusion and exclusion criteria
breast cancer survivors in stage 1 or 2 that are at least in a 6 month interval from their last chemotherapy or radiation therapy will be entered the study and survivors with metastatic cancer, disease recurrence and other physical or psychological disease that affect on sexual function will be excluded
Intervention groups
The intervention groups include one group with educational intervention(4 sessions) and one control group without education.
Main outcome variables
FSFI-BC have sub-scales which will be evaluated:
changes after cancer, desire /arousal , lubrication,orgasm, pain and distress about sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190107042278N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Marzieh Masjoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
masjoudi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effects of sexual health education on improving sexual function in breast cancer survivors
Public title
improving sexual function in breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
married Iranian breast cancer survivors
being in stage 1 or 2
at least 6 month interval from their last chemotherapy or radiation therapy
Exclusion criteria:
metastatic cancer
disease recurrence
other physical or psychological disease that can affect sexual function
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
FSFI-BC will be used for evaluating the effects of intervention . This instrument has been translated and validated by the research team
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی
Street address
Shahid Beheshti University of medical sciences, Arabi Ave.Daneshjoo Blvd.Velenjak , Tehran,Iran Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.SBMU.PHNM.1395.496
Health conditions studied
1
Description of health condition studied
sexual function
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sexual function will be evaluated with FSFI-BC. It has phrases separately for sexually active and non- sexually active women .This scale has 6 domaines : changes after cancer , desire, lubrication , orgasm, pain and distress.For 5 phrases in Changes after cancer , total scores is considered between 5 and 25.
Timepoint
Firstly before education and second one week after last educational session
Method of measurement
For changes after cancer ,total score less than 15 means sexual function deterioration and need follow up.Increasing mean score in second stage is considered as improve in sexual function.
2
Description
For desire domain with 6 phrases , the scores are between minimum 5 and maximum 30.
Timepoint
Firstly before education and second one week after last educational session
Method of measurement
the total score less than 12 need follow up.Increasing mean score in second stage is considered as improve in sexual function.
3
Description
vaginal lubrication include 4 item with minimum score 4 and maximum 20.For sexually active women with adding one item for using lubricant ,the maximum score reaches to 24.
Timepoint
Firstly before education and second one week after last educational session
Method of measurement
total score less than 12 need follow up.Increasing mean score in second stage is considered as improve in sexual function.
4
Description
Orgasm include 3 phrases and scores between 3 and 15.
Timepoint
Firstly before education and second one week after last educational session
Method of measurement
total score less than 9 means function deterioration and need follow up.Increasing mean score in second stage is considered as improve in sexual function.
5
Description
pain is evaluated with 3 phrases and scores between 3 to 15l This domain will be evaluated through reverse scoring .So score 5 means the worst situation.
Timepoint
Firstly before education and second one week after last educational session
Method of measurement
total score less than 9 means function deterioration and need follow up.Increasing mean score in second stage is considered as improve in sexual function.
6
Description
Distress domain include 6 phrases with score from 6 to 30.
Timepoint
Firstly before education and second one week after last educational session
Method of measurement
total score less than 18 means function deterioration and need follow up.Increasing mean score in second stage is considered as improve in sexual function.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: FSI-BC questionnaire will be completed at beginning for all participants who have inclusion criteria. Then individuals will be take part in 4 educational sessions. FSFI-BC will be completed again the one week , after the last educational session.
Category
Behavior
2
Description
Control group: The secon intervention group or Control group members have the same criteria of intervention group 1 and will be selected from the attendance list of cancer research center. FSFI-BC will be completed at beginning and the end of study (the same time as intervention group).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
cancer research center of Shohadaye-Tajrish hospital and virtual campaign of combating the breast ca
Full name of responsible person
Zohre Keshavarz
Street address
School of Nursing and Midwifery of Shahid Beheshti University of medical sciences, Niayesh intersection , Vali-e-Asr street, Tehran,Iran