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
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Karaman, Turcja (Türkiye)
- Karamanoğlu Mehmetbey University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Grupa kontrolna
|
|
|
Eksperymentalny: experimental group
Sexual Counseling Based on the EX-PLISSIT Model
|
Sexual counseling in the intervention group will be conducted according to the 4-stage EX-PLISSIT model.
The EX-PLISSIT model will be implemented by the first author (SK), a specialist nurse who completed a PhD in obstetrics and gynecology nursing with a focus on sexuality.
Furthermore, the first author (SK) attended a 120-hour Sexual Therapy Training Certificate Program prior to the study.
This will be conducted both individually and in a group setting online.
Appropriate training packages in the form of video clips, images, and audio recordings will be created by the research team and then shared via WhatsApp.
The intervention consists of four counseling sessions, each lasting 30 to 60 minutes, once a week for four weeks.
The control group will receive only routine care without any intervention.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Measuring the effect of sexual counseling on sexual function based on the BETTER model.
Ramy czasowe: one month
|
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 |
one month
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Measuring the effect of sexual counseling on sexual distress based on the BETTER model
Ramy czasowe: one month
|
After sexual counseling based on the EX-PLISSIT model, the Female Sexual Distress Scale-Revised (FSDS-R) 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 Distress Scale-Revised (FSDS-R) scale were measured one months after sexual counseling based on the BETTER model. Female Sexual Distress Scale-Revised (FSDS-R) Developed by Derogatis et al. (2008) to measure personal distress related to sexuality in women. The FSDS-R is a 13-item, 5-point Likert-type scale where items are scored on a 0-4 scale. The minimum score that can be obtained from the FSDS-R is "0", and the maximum score is "52". A higher score indicates a higher level of sexual distress. The cutoff point of the scale is 11.5. A score of 11.5 ≥ indicates the presence of sexual distress. |
one month
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Rosen 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.
- Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010 May;7(5):1822-30. doi: 10.1111/j.1743-6109.2010.01728.x. Epub 2010 Mar 3.
- Derogatis 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.
- Zahan, A., Sharma, N. K., Islam, M. N., Sen, S., & Bhowmik, K. R. (2025). Menopausal Symptoms and Coping Strategies among Women of 40-60 Years Age-Group: A Tertiary Care Hospital Experience from Bangladesh. Community Based Medical Journal, 14(1), 54-60.
- Taylor B, Davis S. Using the extended PLISSIT model to address sexual healthcare needs. Nurs Stand. 2006 Nov 22-28;21(11):35-40. doi: 10.7748/ns2006.11.21.11.35.c6382.
- Karadeniz, 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.
- Zangeneh 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.
- Wettergren 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.
- Annon JS. The PLISSIT model: a proposed conceptual. General procedures: handbook of behavior therapy with sexual problems. 2013; 1:70.
- Yörük F, Karacam Z. The effectiveness of the PLISSIT model in solving postpartum sexual problems experienced by women. Athens J Health. 2016;3(3):235-7.
- Yu Y, Sherman KA. Communication avoidance, coping and psychological distress of women with breast cancer. J Behav Med. 2015 Jun;38(3):565-77. doi: 10.1007/s10865-015-9636-3. Epub 2015 Mar 25.
- Ghaemi SZ, Keshavarz Z, Tahmasebi S, Akrami M, Heydari ST. Conflicts women with breast cancer face with: A qualitative study. J Family Med Prim Care. 2019 Jan;8(1):27-36. doi: 10.4103/jfmpc.jfmpc_272_18.
- Turkish Ministry of Health, Public Health Institute of Turkey, Turkish Cancer Statistics, Ankara, 2021 [cited 2021 29.09.2021].https://hsgm.saglik.gov.tr/depo/birimler/kanser-db/istatistik/Turkiye_Kanser_Istatistikleri_2017.pdf
- Kocamaz D, Tuncer A, Yamak D, Sever O, Yıldırım M. Cancer and oncological rehabilitation. Journal of Zeugma Health Research Journal. 2019; 1:24-9.
- WHO. World Health Organization Cancer, 2020 [cited 2022 15.01.2022]. https://gco.iarc.fr/tomorrow/en/dataviz/ isotype?types=0&single_unit=500000
- Parkin DM, Hammerl L, Ferlay J, Kantelhardt EJ. Cancer in Africa 2018: The role of infections. Int J Cancer. 2020 Apr 15;146(8):2089-2103. doi: 10.1002/ijc.32538. Epub 2019 Aug 2.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- DECISION 02-2026/44
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .