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The effect of Social Network-Based Supportive Program (Whats App) on the sexual self-concept of women with breast cancer

Protocol summary

Study aim
Determining the effect of Social Network-Based Supportive Program(whatsapp) on the sexual self-concept of women with breast cancer
Design
The trial included two control and intervention groups, in parallel and not blind and random.
Settings and conduct
location: The oncologist clinic will be in Sari. Randomization into 2 groups of intervention and control. 8 sessions of 45-minute are performed twice a week for the intervention group. The evaluation is performed in 3 times of before, immediately and one month after the intervention.
Participants/Inclusion and exclusion criteria
Admission: , At least education, married women of childbearing age,One week after the last course of treatment, stages 1 to 3 of the disease, living with a spouse, no history of adverse events, Failure to attend sexual health-related classes , no depression, anxiety and severe stress Failure to enter: absence of more than 2 sessions, exacerbation of the disease, adverse events, severe complications from radiotherapy, failure to continue cooperation.
Intervention groups
WhatsApp messenger support program sessions will be held in 8 sessions, 2 sessions of 45 minutes per week. In the intervention group awareness about breast cancer, its effects on cohabitation and sexual self-concept, anatomy and sexual cycle, misconceptions, self-esteem in sexual relations, coping with shame and body image, sensory focus technique, marital satisfaction, solving skills and cceptance of supportive relationships and answers to patients' questions in the group as well as homework assessment will be addressed. At the end and 1 month later, the questionnaires will be completed by the intervention and control group to follow up. The control group will also receive audio and video files in 8 sessions that no related to sexual self-concept.
Main outcome variables
sexual self-concept

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150608022609N8
Registration date: 2020-07-02, 1399/04/12
Registration timing: registered_while_recruiting

Last update: 2020-07-02, 1399/04/12
Update count: 0
Registration date
2020-07-02, 1399/04/12
Registrant information
Name
Zohre Shahhosseini
Name of organization / entity
Mazandaran Univercity of Medical Science, Nasibe School Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.shahhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Social Network-Based Supportive Program (Whats App) on the sexual self-concept of women with breast cancer
Public title
The effect of supportive program on sexual self-concept of women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian, At least primary education, Married women of childbearing age, One week after the last course of treatment (radiotherapy), Stage 1 to 3 of the disease, Living with a spouse for the past 4 weeks , No history of adverse event (such as death of a family member and severe accident) in the last 3 months, Failure to attend sexual health-related classes in the last 6 months, No depression, anxiety and severe stress according to the DASS-21 questionnaire, Satisfaction with participating in the research.
Exclusion criteria:
Absence of more than 2 sessions in intervention meetings, Exacerbation of the disease (occurrence of new metastases), Occurrence of an adverse event (death of family members or accident leading to disability and divorce) during the study and until follow-up, Severe complications caused by radiotherapy, failure to continue cooperation in completing the questionnaire.
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)
Randomized
Randomization description
After completing the informed consent form, the eligible individuals will receive an explanation about the purpose of the study and its importance. Then the Depression, Anxiety and Stress Questionnaire (DASS-21) will be administrated to participants and the one with 15 or higher score for the depression scale and 13 and above for the anxiety scale and 18 and above for the stress scale will be excluded from the study. They will be provided with additional information on how to study and randomly assign to the control and intervention groups. Also, In terms of ethics, there will be an opportunity to answer possible questions for participants, who are not eligible to continue and if necessary, they will be advised to refer to medical centers. Then, 60 eligible patients will be randomly divided into two groups. In this way, using computer software and based on the Permuted block randomization method, using 4 and 6 blocks between the numbers one to 60, two groups of A and group B will be determined. According to the statistical consultant, numbers from 1 to 60 were written on 60 envelopes, and the names of the groups were included in the each envelope according to the computer program. Patients will be randomly selected by the researcher according to the envelope and they will be randomly selected in one of the two intervention or control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the first outcome is the impact of a social network-based support program (Whats App) on the sexual self-concept of women with breast cancer. As a secondary outcome of this study, the quality of sexual life of women with breast cancer will also be measured. Also, the clients' satisfaction questionnaire from counseling will be measured.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University Of Medical Sciences
Street address
Deputy Of Research And Technology Of Mazandaran University Of Medical Sciences, Moallem Square, Moallem Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.MAZUMS.REC.1399.161

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-concept measurement
Timepoint
Before, immediately after the intervention and a month later
Method of measurement
Multidimensional Sexual Self-concept Questionnaire

Secondary outcomes

1

Description
Sexual quality of life
Timepoint
Before, immediately after the intervention and a month later
Method of measurement
Women's Sexual quality of life Questionnaire, higher scores indicate better quality of life.

2

Description
Client Satisfaction
Timepoint
Immediately after the intervention and a month later
Method of measurement
Client Satisfaction Questionnaire

Intervention groups

1

Description
Intervention group: The social network-based support program (Whats App) will be implemented in 8 sessions, 2 sessions of 45 minutes per week. Each session is dedicated to the roll call and introduction of participants in the first 10 minutes. Then listening to the pre-prepared voice file in 20 minutes. After that, there will be 15 minutes for possible questions and answers. In addition, at the end of the sessions, participants are given a series of homework assignments that they must prepare for the next session and send to the personal account of the researcher in Whats App. The summary of the sessions is as follows: The first session : providing information about breast cancer, the effects of breast cancer on patients' lives and sexual self-concept, second session: training anatomy and sex cycle in men and women, third session includes: providing information about misconceptions and replacing them with correct concepts, fourth: strengthening Self-confidence and self-esteem in sexual intercourse, fifth session includes: teaching how to deal with shame in sexual intercourse and deciding to solve it and body image, sixth session: teaching the technique of sensory focus and explaining how to complete the session self-assessment form, session 7 includes: teaching strategies to enhance marital satisfaction and expressing feelings and opinions about sexual behavior, eighth session includes: training problem-solving skills and acceptance of supportive relationships. At the end of 8 sessions of intervention and 1 month later for follow-up, Snell's Multidimensional Sexual Self-Concept Questionnaire (MSSCQ), Rosen’s The Female Sexual Function Index Questionnaire (FSFI), Body Image Scale (BIS), The sexual quality of life-female Questionnaire (SQOL-F) and Customer Satisfaction Questionnaire (CSQ-8) will be completed by the intervention group by Porss Line.
Category
Other

2

Description
Control group:The control group will also receive audio and video files in 8 sessions that no related to sexual self-concept. This group will complete the questionnaires again 4 weeks after completing the initial questionnaire and 1 month later.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Private Office of The Project's Expert Consultant (Radio-oncologist)
Full name of responsible person
Arash Ghasemi
Street address
Unit 403,Ati Fan Building (Book City),At the beginning of Bahman Gharbi, Payam-e-Noor St, Sari
City
Sari
Province
Mazandaran
Postal code
4818859794
Phone
+98 11 3325 7753
Email
Dr_Arash_Ghasemi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akbar Hedayatizadeh Omran
Street address
Deputy Of Research And Technology Of Mazandaran University of Medical Sciences, Moallem Square, Moallem Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3325 7230
Email
Akbar-Hedayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hamidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Azadi Street- Nehzat Street- Imam Square
City
Sari
Province
Mazandaran
Postal code
4814864664
Phone
+98 11 3339 8858
Email
Fateme.hamidi7575@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Shahhosseni
Position
Ph.D in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh Nursing And Midwifery faculty, Vesal Shirazi Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Fax
Email
Zshahhosseni@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Hamidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Azadi Street- Nehzat Street- Imam Square
City
Sari
Province
Mazandaran
Postal code
4814864664
Phone
+98 11 3339 8858
Email
Fateme.Hamidi7575@gmail.com

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
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