Determination of effectiveness of cognitive behavioral therapy on sexual function and satisfaction of women with breast cancer after mastectomy
Design
Clinical trial with two intervention and control groups, simple randomized, each group with 21 participants.
Settings and conduct
Women with breast cancer are selected according to inclusion and exclusion criteria from all women reffered to the oncology ward of Golestan hospital in Ahvaz who have sexual dysfunction. the model of cognitive-behavioral therapy is explained and homework assignments are given. The feedback on the efficacy of the treatment, female sexual function index questionnaire and Larson questionnaire is completed by the intervention group after the end of the eight sessions.for control group, they will be given a training session
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with age 18-49; women with breast cancer after mastectomy; score less than 26.5 of female sexual function index questionnaire and less than 75 of Larson's sexual satisfaction questionnaire; married; to have sexual relation with husband; after complete chemotherapy
Exclusion criteria: Menopause; pregnancy and lactation; psychotic disorder; hysterectomy; use drug or alcohol dependency; or psychotropic substances; treatment of another type of cancer or malignancy.
Intervention groups
Cognitive behavioral therapy is performed as 8 group sessions of 90-minute in three groups of 7 individuals and once a week by the researcher. The feedback on the efficacy of the treatment, female sexual function index questionnaire and Larson questionnaire is completed by the intervention group after the end of the eight sessions. after 2 month call to control group and female sexual function index and Larson questionnaires is completed and they will be given a training session.
Main outcome variables
1. sexual function
2.sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180616040113N1
Registration date:2019-02-15, 1397/11/26
Registration timing:retrospective
Last update:2019-02-15, 1397/11/26
Update count:0
Registration date
2019-02-15, 1397/11/26
Registrant information
Name
Fatemeh Farhadi Cheshmeh Morvari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8395
Email address
farhadi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Cognitive Behavioral Therapy (CBT) on sexual function and satisfaction of women with breast cancer after mastectomy
Public title
The effect of Cognitive Behavioral Therapy (CBT) on sexual function and satisfaction of women with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with breast cancer after mastectomy
Score less than 26.5 of female sexual function index questionnaire
Married
To have sexual relation with husband
To have minimum one child
After complete of chemotherapy course
Diagnosis of breast cancer 6 month till 5 years before present in research
Ability to attend in group therapy session
Having at least elementary education
Score less than 75 of Larson sexual satisfaction questionnaire
Reproductive ages 18-49 years
Exclusion criteria:
Pregnancy and lactation
Chronic diseases such as hypertension, diabetes and thyroid disease, and autoimmune diseases
Menopause
Taking antipsychotic drugs during the past 6 months
Psychiatric disorders
Use of Hormone Replacement Therapy (HRT)
Drug addiction or alcohol dependence or psychoactive materials based on personal comments
Treatment another type of cancer or malignancy
Participate in concurrent therapy programs to reduce sexual problems and reduce other psychological problems
The occurrence of a unpleasant event during the last 6 months
Hysterectomy
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:
42
Randomization (investigator's opinion)
Randomized
Randomization description
In order to intervention, the women will be divided into two groups of 21 participants as control and intervention groups in randomized blocking , using four blocks and a one to one allocation ratio by use RAS software. Then,the intervention and control group's numbers will be held in envelops by block rows. The envelops will be closed and by Golestan Hospital's oncology secretary, they will be randomly assigned to eligible individuals in the study.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Faculty of Nursing and Midwifery Ahvaz Jundishapur, Esfand Ave, Golestan Blvd, Ahvaz, Khuzestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.AJUMS.REC.1397.189
Health conditions studied
1
Description of health condition studied
Sexual function of women with breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Sexual function of women with breast cancer
Timepoint
Before the intervention- 8 weeks after intervention
Method of measurement
Female sexual function index questionnaire
2
Description
Sexual satisfaction
Timepoint
Before the intervention- 8 weeks after intervention
Method of measurement
Larson sexual satisfaction questionnaire
Secondary outcomes
1
Description
Sexual desire
Timepoint
Before intervention- 8 weeks after intervention
Method of measurement
Female sexual function index questionnaire
2
Description
Sexual arousal
Timepoint
Before intervention- 8 weeks after intervention
Method of measurement
Female sexual function index questionnaire
3
Description
Vaginal Lubrication
Timepoint
Before intervention- 8 weeks after intervention
Method of measurement
Female sexual function index questionnaire
4
Description
Orgasm
Timepoint
Before intervention- 8 weeks after intervention
Method of measurement
Female sexual function index questionnaire
5
Description
Dyspareunia
Timepoint
Before intervention- 8 weeks after intervention
Method of measurement
Female sexual function index questionnaire
6
Description
Sexual pleasure
Timepoint
Before intervention- 8 weeks after intervention
Method of measurement
Female sexual function index questionnaire
Intervention groups
1
Description
Intervention group: Cognitive behavioral therapy result in more positive attitude toward sexual relation and improved sexual function disorder of couples. Cognitive-behavioral therapy is organized in 8 group sessions.The research samples are divided into 3 groups of 7 people. The sessions are organized by a researcher once a week for 90 minutes. Educational content includes: Familiarity of members with each other and explaining the model of cognitive-behavioral therapy, Identifying their own thoughts and finding negative thoughts on sexual issues, types of beliefs and changing wrong beliefs, analysis of beneficial, body image and its changes during chemotherapy and mastectomy, relaxation training and imagination and confront negative excitements.Homework is given to the participants. After the end of eight sessions, the sexual function and sexual satisfaction questionnaires are completed by the intervention group.
Category
Treatment - Other
2
Description
Control group: Before starting treatment, sexual function Index and sexual satisfaction questionnaires are completed by the control group. Two months after starting treatment, the control group is contacted and sexual function Index and sexual satisfaction questionnaires are again completed, A training session is given to them.Educational content includes body image and its changes during chemotherapy and mastectomy, relaxation training and imagination and confront negative excitements.They are referred to consultant if they wish.