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IRCT20260516069422N1 IRCT 2026-07-15 Yazd University of Medical Sciences Effectiveness of Sexual Health Enhancement Program versus Relationship Enhancement Program on Sexual Function and Marital Satisfaction in Gynecologic and Breast Cancer Survivors 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 2026-07-23 anticipated 66 Recruiting https://irct.ir/trial/90173 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Condition 1: ٍEndometrial Cancer. Condition 2: ovarian cancer. Condition 3: Cervical Cancer. Condition 4: Breast Cancer. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All individual data of study participants can be shared after de-identification. When: After publishing the results To whom: The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them. Conditions: 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. Where to obtain: Dr. Tahmineh Farajkhoda farajkhodatahmineh@gmail.com How to obtain: One week after receiving the applicant's email Comments:
public Tahmineh Farajkhoda
Bu Ali St.
Yazd Iran (Islamic Republic of) 8916877443 +98 35 3824 1751 farajkhodatahmineh@gmail.com Yazd University of Medical Sciences scientific Tahmineh Farajkhoda
Bu Ali St.
Yazd Iran (Islamic Republic of) 8916877443 +98 35 3824 1751 farajkhodatahmineh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 no limit no limit Female 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 N85.02 E28.8 G54.2 C50 Endometrial intraepithelial neoplasia [EIN] Other ovarian dysfunction Cervical root disorders, not elsewhere classified Malignant neoplasm of breast Behavior Behavior 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. 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 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. 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. Yazd University of Medical Sciences Approved 2026-05-04 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Yazd. Bahonar Square Yazd Yazd Iran (Islamic Republic of)