1. Home
  2. Approved trials
  3. » فارسی

Effectiveness Comparison of the Sexual Health Enhancement Program (SHE) versus the "Hold Me Tight" (HmT) Relationship Enhancement Program on Sexual Function and Marital Satisfaction in Gynecologic and Breast Cancer Survivors

Protocol summary

Study aim
To compare the effectiveness of the sexual health enhancement program with the "Hold Me Tight" relationship enhancement program on sexual function and relationship satisfaction in gynecological and breast cancer survivors
Design
Parallel randomized clinical trial with control group, random allocation with permutation block method, sample size of 33 women in each intervention group (total sample size: 66 women)
Settings and conduct
The research setting includes Baghaeipour and Ramezanzadeh clinics in Yazd. Sampling will be done by convenience method based on suitability to participate in the study among all women survivors of gynecological cancers and breast cancer in Yazd. Women will be randomly assigned to two groups. For women in both groups, 8 weekly 60-minute online counseling sessions will be held in Sky Room.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having or having a history of gynecological or breast cancers Six months after radiotherapy and chemotherapy for affected women Having sex with spouse Obtaining a score lower than 28 on the Rosen FSFI questionnaire Exclusion criteria: Cancer recurrence at the time of sampling Pregnancy Extensive surgeries in the pelvic area Women with severe surgical complications Refraining from sexual intercourse as ordered Mental disorders
Intervention groups
The first intervention group will receive the the Sexual Health Enhancement Program and the second intervention group (active control) will receive the "Hold Me Tight" program both for 8 consecutive weeks and 60-minute online counseling.
Main outcome variables
sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260516069422N1
Registration date: 2026-07-15, 1405/04/24
Registration timing: prospective

Last update: 2026-07-15, 1405/04/24
Update count: 0
Registration date
2026-07-15, 1405/04/24
Registrant information
Name
Arefe Radaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 3714
Email address
a.radaie@stu.ssu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness Comparison of the Sexual Health Enhancement Program (SHE) versus the "Hold Me Tight" (HmT) Relationship Enhancement Program on Sexual Function and Marital Satisfaction in Gynecologic and Breast Cancer Survivors
Public title
Effectiveness of Sexual Health Enhancement Program versus Relationship Enhancement Program on Sexual Function and Marital Satisfaction in Gynecologic and Breast Cancer Survivors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having or having a history of gynecological and breast cancers (recorded in the file) Six months after radiotherapy and chemotherapy for affected women Having sex with spouse Being literate Obtaining a score lower than 28 on the Rosen FSFI questionnaire Having an Android or iOS smartphone Ability and access to use the Internet and online counseling with a smartphone Willingness to participate in the study Informed consent and agreement to participate in treatment sessions
Exclusion criteria:
Cancer recurrence at the time of sampling Pregnancy Having severe marital conflicts Participating in other psychological interventions Women being hospitalized for any reason Extensive surgeries in the pelvic area Women undergoing vaginal brachytherapy Women with severe surgical complications Refraining from sexual intercourse as ordered by the relevant physician Psychological disorders (psychotic disorders and taking psychiatric medications based on medical records) Mental disorders Using alcohol, drugs, and psychotropic medications based on medical records
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of study participants to the two groups of the Sexual Health Improvement Program and the Hold Me Tight Program is done using the permutation block method. The randomization sequence is determined by a bio-statistician and is obtained by considering 15 blocks of size 4 and 1 block of size 6 after generating random numbers using software online (using the site www.random.org/sequences/). For blocks of four, each random number will be assigned one of the following permutations: ABBA, BAAB, ABAB, BABA, AABB, BBAA And for blocks of six, the random numbers will be assigned the permutation BAABBA. To ensure allocation concealment, the randomization sequence will be prepared by a bio-statistician and placed in sequentially numbered, opaque, sealed envelopes. After obtaining written informed consent from each eligible participant, the next consecutively numbered envelope will be opened by the researcher according to the participant's order of enrollment, and the participant's group assignment will be revealed. Thus, the researcher will remain unaware of the upcoming allocation until the envelope is opened, thereby preventing prediction or manipulation of the allocation sequence. Again, each group will be divided into two subgroups of 16 and 17 people using a simple random method.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd. Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2026-05-04, 1405/02/14
Ethics committee reference number
IR.SSU.REC.1405.018

Health conditions studied

1

Description of health condition studied
ٍEndometrial Cancer
ICD-10 code
N85.02
ICD-10 code description
Endometrial intraepithelial neoplasia [EIN]

2

Description of health condition studied
ovarian cancer
ICD-10 code
E28.8
ICD-10 code description
Other ovarian dysfunction

3

Description of health condition studied
Cervical Cancer
ICD-10 code
G54.2
ICD-10 code description
Cervical root disorders, not elsewhere classified

4

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
sexual function
Timepoint
Baseline - Completion of the intervention in the 8th week - Follow-up at the end of the study in the 12th week
Method of measurement
Rosen Women's Sexual Function Index Questionnaire

Secondary outcomes

1

Description
Marital Satisfaction
Timepoint
Baseline - Completion of the intervention in the 8th week - Follow-up at the end of the study in the 12th week
Method of measurement
Hendrick Relationship Assessment Scale

Intervention groups

1

Description
Intervention Group 1: Participants in the first intervention group will receive the Hold Me Tight (HmT) Relationship Enhancement Program in eight weekly online sessions, each lasting 60 minutes, delivered via the Skyroom platform. The sessions will be conducted by the second researcher, a Master's student in Midwifery Counseling trained and certified in Emotionally Focused Therapy (EFT) under the supervision of the principal researcher (thesis supervisor), a reproductive health specialist and clinical psychologist, and the third researcher (thesis advisor), a reproductive health specialist. Each session will include didactic presentations, group discussions, question-and-answer activities, review of the previous session’s homework assignments, and assignment of homework for the following session.The Hold Me Tight (HmT) Relationship Enhancement Program consists of eight weekly sessions covering the following topics: (1) introduction to the program, attachment principles, and relationship enhancement; (2) identification of negative interaction patterns and conflict cycles; (3–4) identification of vulnerabilities and emotional injuries, and reprocessing of difficult relational interactions; (5) training in safe conversations based on the A.R.E. (Accessibility, Responsiveness, and Engagement) model, with emphasis on expressing emotional needs and feelings; (6) fostering forgiveness, acceptance, and repair of relationship injuries; (7) enhancement of emotional and sexual intimacy and management of cancer-related sexual concerns; and (8) consolidation of acquired skills, strengthening the couple’s emotional bond, and developing strategies to maintain long-term relationship improvements.
Category
Behavior

2

Description
Active Control Group: Participants in the active control group will receive the Sexual Health Enhancement (SHE) Program in eight weekly online sessions, each lasting 60 minutes, delivered via the Skyroom platform. The sessions will be conducted by the second researcher, a Master's student in Midwifery Counseling who has completed formal training in the management of sexual dysfunctions and obtained the relevant certification, under the supervision of the principal researcher (thesis supervisor), a reproductive health specialist and clinical psychologist, and the third researcher (thesis advisor), a reproductive health specialist. Each session will include educational presentations, group discussions, question-and-answer activities, review of the previous session's content and homework assignments, and assignment of homework for the subsequent session. The program is designed to enhance participants' knowledge, attitudes, and skills related to sexual health and sexual function, and to improve their sexual adjustment following cancer.The Sexual Health Enhancement (SHE) Program consists of eight weekly sessions covering the following topics: (1) introduction to the program, establishment of a safe and supportive environment, and identification of sexual concerns following cancer; (2) education on the impact of cancer and its treatments on sexual health and sexual function, correction of sexual misconceptions, and assessment of participants' sexual needs; (3–4) training in communication skills, empathy, recognition of emotional and sexual needs, and basic sexual anatomy; (5) education on the anatomy and physiology of the sexual response, sex differences in sexual response, and the effects of cancer treatments on sexual function; (6) strategies for improving sexual function, reducing pain during sexual activity, enhancing intimacy, and gradually restoring sexual relationships; (7) addressing body image concerns and correcting misconceptions regarding sexual relationships after cancer; and (8) review of key concepts, reinforcement of acquired skills, and development of strategies to maintain long-term improvements in sexual health
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghaeipour Specialized and Subspecialty Polyclinic
Full name of responsible person
Dr. Pour Mirafazl
Street address
Yazd - Safaieh, Riazi Square, next to the main door of Shahid Sadoughi Educational and Medical Hospital
City
Yazd
Province
Yazd
Postal code
8915887856
Phone
+98 35 3183 3737
Email
baghaei@ssu.ac.ir
Web page address
https://baghaei.ssu.ac.ir/

2

Recruitment center
Name of recruitment center
Shahid Ramezanzadeh Radiotherapy Center
Full name of responsible person
Dr. Seyed Ali Akbar Mousavi
Street address
Yazd - Shahid Motahari Street - Across Rouhaniyon Gas Station
City
Yazd
Province
Yazd
Postal code
8917657961
Phone
+98 35 3366 8888
Email
partodarmani@ssu.ac.ir
Web page address
https://parto.ssu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi Abargouei
Street address
Yazd, Bahonar Square, Central University Building
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
abargouei@gmail.com
Web page address
https://ssu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Psychologist
Street address
Bu Ali St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhodatahmineh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Psychologist
Street address
Bu Ali St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhodatahmineh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Psychologist
Street address
Bu Ali St.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
farajkhodatahmineh@gmail.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All individual data of study participants can be shared after de-identification.
When the data will become available and for how long
After publishing the results
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them.
Under which criteria data/document could be used
Scientific institutions can send their official request to the email of the scientific director of the project. After the permission of the Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd, the data will be sent. It is not possible to perform statistical analyses on the data.
From where data/document is obtainable
Dr. Tahmineh Farajkhoda farajkhodatahmineh@gmail.com
What processes are involved for a request to access data/document
One week after receiving the applicant's email
Comments
Loading...