Determining the development and validation of a smartphone application to improve the sexual health of breast cancer survivors
Design
Two arm parallel group randomised, Allocation of people using randomized block method,The sample size in each group is 38
Settings and conduct
The researcher selects qualified people by referring to the Motamed cancer research center . Participants are then asked to complete the Female's Sexual Function Index questionnaire. Individuals who score less than 28 will be enrolled in the study and randomly divided into two groups. Prior to the start of the study, the two groups will also complete the body image concern questionnaire and marital satisfaction questionnaires. A group will receive counseling using the developed application. The usability score of the application is also calculated at the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Women in the age group from 18 to 60 years old
2. Married and currently living with a spouse
3. Own a smart android cell phone
4. Presence of sexual dysfunction based on the FSFI questionnaire with a score of less than 28
5. Diagnosis of non-invasive breast cancer within the past six years
6. at least three months have passed since mastectomy or lumpectomy, and adjuvant treatment
7. Proficiency in spoken and written Persian language.
8. internet access;
Exclusion criteria:
1. Existence of mental illnesses, severe problems in marital relations, polygamy
2. Simultaneous treatment for another type of cancer, reducing sexual, emotional and psychological problems
Intervention groups
In the intervention group, people will use the sexual health application and the control group will receive a sexual health booklet at the end of the study.
Main outcome variables
sexual function; Body image concern; marital satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059348N1
Registration date:2023-10-14, 1402/07/22
Registration timing:prospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Fatemeh bagheri
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 0000
Email address
fatemehbagheri83@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and validation of a smartphone application to improve the sexual health of breast cancer survivors.
Public title
Development and validation of sexual health application
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the age group of 18 to 60 years
Married and currently living with a spouse
Having a smart Android mobile phone
Existence of sexual dysfunction based on the FSFI questionnaire and scoring less than 28
Diagnosed with non-invasive breast cancer within the last six years at most
At least three months have passed since mastectomy or lumpectomy and receiving adjuvant treatment (such as radiation therapy, chemotherapy or hormone therapy)
spoken and written proficiency in Persian language
Internet access
Exclusion criteria:
Existence of mental illnesses
Simultaneous treatment of another type of cancer
The presence of severe problems in marital relationships (for example, the presence of significant violence or abuse and conflict with the spouse - measured by screening questions such as how is your general relationship with your spouse?, Do you live in the same house?, Do you share a bedroom and bed ?)
Simultaneous treatment to reduce sexual, emotional and psychological problems5. Existence of polygamy
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization method will be used to allocate the participants in the study groups, so that according to the groups under investigation (2 groups), AABB blocks of 4 will be formed, and then all possible combinations of them will be formed, will be listed and a code will be assigned for each of these combinations, then according to the sample volume (76) and the volume of blocks, which will be 4, 19 blocks will be allocated.
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
Research ethics committees of tarbiat modares university
Street address
Tehran, Jalal Al Ahmad, Nasr bridge , Tarbiat Modares University
City
تهزان
Province
Tehran
Postal code
1411713116
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.MODARES.REC.1401.141
Health conditions studied
1
Description of health condition studied
sextual health
ICD-10 code
XXI
ICD-10 code description
Factors influencing health status and contact with health services
Primary outcomes
1
Description
The score of sexual function in Female Sexual Function Index(FSFI)
Timepoint
At the beginning of the study (before the start of the intervention), the end of the intervention, one month and three months after the end of the intervention
Method of measurement
Female Sexual Function Index(FSFI) questionnaire
2
Description
Body image concern score in the Body Image Concern Index (BICI) questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), the end of the intervention, one month and three months after the end of the
Method of measurement
Body Image Concern Index (BICI) questionnaire
3
Description
Marital satisfaction score from Enrich Marital Satisfaction Questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), the end of the intervention, one month and three months after the end of the
Method of measurement
Enrich Marital Satisfaction Questionnaire
Secondary outcomes
1
Description
App usability evaluation
Timepoint
End of intervention
Method of measurement
Modified Persian version of the questionnaire of usefulness, satisfaction and ease of use (USE)
Intervention groups
1
Description
"Intervention group" :At first, in the intervention group, based on needs assessment, a sexual health application for people with breast cancer will be designed and implemented by the researcher.. By using the password, people are added to the application. In this research, the assessment of sexual health of people will be based on the determinants of the Woods conceptual model and the intervention based on the PLISSIT approach. Intervention strategies include four stages of questions and answers about sexual issues and sexual beliefs, education about sexual misconceptions, sexual and marital counseling, and referral to specialists including urology, infectious diseases, gynecology, and psychologists, depending on the needs of each person. The researcher will guide the participants to each of these strategies in a period of 4 months with weekly sessions (the interval between weeks will be determined based on the needs of the patient and individually) of 45 minutes and It will carry out three question and answer strategies, training and counseling, and at the end, if needed, it will refer the participants to one or more experts. The first intervention strategy includes question and answer sessions in the form of text, audio or, if the participants wish, video. Another strategy is education intervention, education is divided into two sub-sets, general education about sexual health that is done for all participants and referring the individual or couple to a specific topic that is based on the existing problem of education in that context is required and is provided to the participants in the form of a figure, text, slide or video. In another strategy, counseling intervention takes place. Counseling will be done mainly online, and if needed, the person will be referred to specialists. The last strategy is active referral to the relevant specialist. According to the patient's needs, active referrals are made by the researcher, and according to the needs of the individual, online communication or face-to-face referrals are made. At the end of each session, the modules selected by the therapist will be provided to each person according to their needs, and then the homework results report will be sent through another module in the form of a text message.
Category
Rehabilitation
2
Description
"Control group": Control group: At the end of the study, the control group will receive the booklet "Sexual health in breast cancer patients" and if the intervention is effective, the application will also be available to them.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Motamed Research Institute (Breast Cancer Research Center) Jihad University
Full name of responsible person
Shahpar Hghighat
Street address
Address: Building No. 1: Tehran - Vanak Square - South Gandi Beginning - No. 146 / Building No. 2: Tehran - Enghelab St. - Aburihan St. - Vahid Nazari St. - No. 45
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 8887 6869
Fax
Email
info@ibcrc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Tarbiat Modares
Full name of responsible person
Lida Moghaddam-Banaem
Street address
Tehran, Jalal Al Ahmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
Res@modares.ac.ir
Grant name
Twenty million tomans
Grant code / Reference number
70673
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Tarbiat Modares
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
Tarbiat Modares University
Full name of responsible person
Fatemeh Bagheri
Position
Student
Latest degree
Master
Other areas of specialty/work
بهداشت باروری
Street address
Jalal Al Ahmad St., Tarbiat Modares University, PO Box: 175-14115.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Fax
Email
fatemehbagheri83@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Lida Moghaddam-Banaem
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
بهداشت مادر و کودک
Street address
Tehran, Jalal Al Ahmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3857
Email
moghaddamb@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Bagheri
Position
Student
Latest degree
Master
Other areas of specialty/work
بهداشت باروری
Street address
Jalal Al Ahmad St., Tarbiat Modares University, PO Box: 175-14115.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Fax
Email
fatemehbagheri83@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
The data will be available to researchers working in universities and industry.
Under which criteria data/document could be used
Any type of analysis or statistical use of data whose results help to improve the quality of life and health of the participants under study or have a positive scientific result in this field will be allowed.
From where data/document is obtainable
Data will be sent through e-mail fatemehbagheri83@yahoo.
Fatima Bagheri
Tehran, Jalal Al Ahmad, Nasr bridge , Tarbiat Modares University, PO Box: 111-14115. Faculty of Midwifery and Reproductive Health.
Data will be sent via e-mail moghaddamb@modares.ac.ir.
Lida Moghadam Benaim
Tehran, Jalal Al Ahmad, Nasr bridge , Tarbiat Modares University, PO Box: 111-14115.
Faculty of Midwifery and Reproductive Health.
What processes are involved for a request to access data/document
After the request by the requester, his request will be immediately checked by the research team, after the confirmation of the research team to provide the results to the requester, verification will be done from the requester, if the verification is approved, the data will be provided within 6 weeks after the request.