Clinical trial · Interventional
THE IMPACT OF WHATSAPP BASED EX-PLISSIT MODEL SEXUAL COUNSELING ON THE SEXUAL LIVES OF BREAST CANCER SURVIVORS
THE EFFECT OF WHATSAPP BASED EX-PLISSIT MODEL SEXUAL COUNSELING ON SEXUAL FUNCTION AND SEXUAL DISTRESS IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED STUDY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cancer is a significant health problem negatively impacting human health due to population growth, aging, and lifestyle changes known to cause cancer. According to World Health Organization sources, the number of newly diagnosed cancer patients, which was 19.3 million in 2020, is projected to reach 30.2 million in 2040. Breast cancer, the most frequently diagnosed type of cancer in the female population worldwide, has an incidence of 47.8 per 100,000 globally and 47.7 per 100,000 in Turkey, according to 2020 GLOBOCAN data. Surgical treatment, chemotherapy, radiotherapy, and hormonal therapies used in the treatment of breast cancer, which has a high incidence worldwide and causes significant loss of workforce, have become important in altering the course of the disease. However, long-term treatments and related complications negatively affect the sexual functions of individuals. Women and men of reproductive age diagnosed with cancer; Even if they have survived cancer and benefited from curative treatments, they face sexual problems caused by the treatment. Individuals diagnosed with and treated for breast cancer experience difficulties in accessing counseling on issues related to their sexuality.Studies have shown that patients are hesitant to discuss sexual matters, need information about sexual problems during and after cancer treatment, but sexual counseling is not included in oncology care, and healthcare professionals focus more on medical issues. In this context, healthcare professionals can utilize many models for sexual counseling. The use of models in assessing sexual health guides healthcare professionals, facilitates the history-taking process, and helps in identifying sexual problems. The International Society for Research on Women's Sexual Health (ISSWSH) aims to establish a basic methodological strategy for identifying sexual problems in women and considering biological, psychological, sociocultural, and related factors that may cause sexual problems. The use of professional sexual assessment models by nurses in questioning and evaluating patient sexuality will be healthier and more effective. PLISSIT and EX-PLISSIT models are widely used by nurses working in primary care settings to address sexual health needs and concerns. The PLISSIT model consists of four levels: P - Permission, LI - Limited Information, SS - Specific Suggestions, and IT - Intensive Therapy. As the intervention stages of the PLISSIT model progress, more comprehensive knowledge, training, and skills are required. The Ex-PLISSIT model has been developed as an extension of the PLISSIT model. Ex-PLISSIT is a more expanded version of the PLISSIT model, with the permission stage at its center. One cannot proceed to the next stage without obtaining permission.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Sex Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sexual counseling group based on the EX-PLISSIT Model | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Sexual Counseling Based on the EX-PLISSIT Model
- interventionNames
- Behavioral: Sexual counseling group based on the EX-PLISSIT Model
Primary outcomes (1)
- measure
- Measuring the effect of sexual counseling on sexual function based on the BETTER model.
- timeFrame
- one month
- description
- After sexual counseling based on the EX-PLISSIT model, the Female Sexual Function Index (FSFI) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes. Changes in the Female Sexual Function Index (FSFI) scale were measured two months after sexual counseling based on the BETTER model. Female Sexual Function Index (FSFI) It was developed by Rosen et al. as a multidimensional scale comprising 19 items to evaluate female sexual function. The scale includes six subheadings, desire, arousal, lubrication, orgasm, satisfaction, and pain. Each title was scored between 0 or 1 and six. The lowest and highest scores are 2 and 36, respectively. Higher scores indicated better sexual function. The cut-off value of the scale was 26.55. A total FSFI score of ≤26.55, it indicates sexual dysfunction
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with breast cancer, stage 0, I, or II, * Having undergone mastectomy, and at least 6 months having passed since the completion of radiotherapy and chemotherapy treatment, * Aged 18-49, not pregnant, not breastfeeding, not menopausal, * Women with sexual dysfunction (FSFI score 26.55 or lower), sexually active, married and living with their spouse. Exclusion Criteria: * Women with chronic, psychological, and physical illnesses, * Those with alcohol and substance abuse, * Those who have previously received education or counseling for sexual dysfunction, * Women diagnosed with cancer other than breast cancer
References
Publications (16)
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- BACKGROUNDKaradeniz, Z.C. (2019). Adaptation of the Female Genital Self-Image Scale and examination of its psychometric properties. Akdeniz University Institute of Health Sciences, Department of Nursing, Master's Thesis, Antalya.
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- BACKGROUNDZangeneh S, Savabi-Esfahani M, Taleghani F, Sharbafchi MR, Salehi M. Effectiveness of online sexual education based on the extended PLISSIT model on sexual function and sexual satisfaction in women undergoing breast cancer treatment. J Educ Health Promot. 2023 Sep 29;12:311. doi: 10.4103/jehp.jehp_1318_22. eCollection 2023. PMID 38023105
- BACKGROUNDRosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. PMID 10782451
- BACKGROUNDDerogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27. PMID 18042215
- BACKGROUNDWettergren L, Kent EE, Mitchell SA, Zebrack B, Lynch CF, Rubenstein MB, Keegan THM, Wu XC, Parsons HM, Smith AW; AYA HOPE Study Collaborative Group. Cancer negatively impacts on sexual function in adolescents and young adults: The AYA HOPE study. Psychooncology. 2017 Oct;26(10):1632-1639. doi: 10.1002/pon.4181. Epub 2016 Jun 20.