Protocol summary
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Study aim
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Determining the Effect of Psychological Training on the Sexual Satisfaction of Women with Breast Cancer
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Design
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Clinical trials with community based and pragmatic control group, parallel groups, blind, randomized, simple blocked
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Settings and conduct
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1. Receipt of permission from the vice chancellor for research in Shiraz University of Medical Sciences and referral to Motahhari clinic of Shiraz.
2. Selection of samples and random blocking in two groups of intervention and control by the researcher but the patient does not know which group is located.
3. Complete the demographic questionnaire and sexual satisfaction and sexual schema by both groups.
4. Educational interventions and cognitive therapy by installing the program on the cellphone of the intervention group and using social networks.
5-control group does not see any training.
6. Completion of the questionnaire and analysis.
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Participants/Inclusion and exclusion criteria
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Entry: Married women with non-metallic breast cancer aged 25-55 years
Non-arrival: Metastatic Breast Cancer Women, Single and Mental Illness
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Intervention groups
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After placing the samples in the intervention and control groups, the intervention group received training in the field of appropriate exercise for breast cancer, stress management and problem-solving and cognitive therapy interventions, but the control group did not receive any training, and only the questionnaire Completed.
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Main outcome variables
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"The effect of psychological training on improving female sexual satisfaction"
"Use the results of the plan for future research"
"Promoting Mental Health in Breast Cancer Women"
General information
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Reason for update
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Enter new information about sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190116042377N1
Registration date:
2019-01-25, 1397/11/05
Registration timing:
prospective
Last update:
2019-11-25, 1398/09/04
Update count:
1
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Registration date
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2019-01-25, 1397/11/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-19, 1397/11/30
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Expected recruitment end date
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2019-04-04, 1398/01/15
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Actual recruitment start date
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2019-04-21, 1398/02/01
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Actual recruitment end date
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2019-06-21, 1398/03/31
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Trial completion date
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2019-08-22, 1398/05/31
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Scientific title
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"Psychosocial Intervention on Sexual Satisfaction of Women With Breast Cancer"
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Public title
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"Sexual Satisfaction in Breast Cancer"
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Married
Age between 25 to 55 years old
It is associated with non-Metastatic Breast Cancer.
The ability to Read and Write.
Ability to work with Android Mobile Phones.
Medical records in Motahhari clinic in Shiraz.
Would like to participate in this Project.
Exclusion criteria:
The patient will have metastatic Breast Cancer.
Crisis or unexpected illness occurs during research.
Separate your spouse from the research.
Participate in other educational interventions.
Has chronic Psychiatric illnesses.
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Age
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From 25 years old to 55 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
102
Actual sample size reached:
102
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first, samples are selected using a random Number Table, then randomly blocked by a researcher in Six blocks in two groups of intervention and control.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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After random selection, samples are entered into two groups of intervention and control in the case of having entered the plan and informed consent for participation in the project. By the fact that the patient knows that he is involved in the research, but in what The group is present and the educational qualities of the groups are not known to the researcher.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-25, 1397/10/04
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Ethics committee reference number
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IR.SUMS.REC.1397.915
Health conditions studied
1
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Description of health condition studied
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Breast Cancer
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ICD-10 code
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ICD-10 code description
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Malignant neoplasm of breastIncl.:connective tissue of breastExcl.:skin of breast (C43.5, C44.5)C50.0Nipple and areolaC50.1Central portion of breastC50.2Upper-inner quadrant of breastC50.3Lower-inner quadrant of breastC50.4Upper-outer quadrant of breastC5
Primary outcomes
1
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Description
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Sexual Satisfaction Scale in Metson and Traponel Sexual Satisfaction Questionnaire
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Timepoint
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Measuring sexual satisfaction score before and after intervention
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Method of measurement
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Scale sexual satisfaction, women Mattson and Trapnl (SSS-W)
Secondary outcomes
1
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Description
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Sexual schema score
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Timepoint
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Measuring the score of sexual cognitive schemas before and after intervention
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Method of measurement
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Questionnaire of Cognitive Schemas Activation in a Sexual Context
Intervention groups
1
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Description
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Intervention group: "Married women with non-metastatic breast cancer" Three sessions with appropriate sports exercises for breast cancer, stress management, and problem-solving training developed in the form of an application are installed on the mobile phone in the intervention group. This group There are also five sessions of cognitive therapy interventions using social networks that aim at these training and interventions to improve sexual behaviors and patient schemas. "The control group does not receive any training." Just complete the questionnaires before and after the end of the intervention.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available