Clinical trial · Interventional
Using BETTER Model Sexual Problems in Breast Cancer
THE EFFECT OF BETTER MODEL COUNSELLING WITH MODEL OVER SEXUAL PROBLEMS OF WOMEN WITH BREAST CANCER
NCT04297657CI-TRIAL-00043842completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Breast cancer and its treatments such as mastectomy, chemotherapy, radiotherapy, hormonal therapy cause many side effects such as scar, problems with body perception and sexual problems. Sexual concerns lead to significant emotional distress, including sadness/depression, issues related to personal appearance, stigma, and negative impacts on personal relationships, intimacy and sexuality all of which reduce the quality of life. This experimental type of research is conducted within the framework of the BETTER model to evaluate the impact of counselling programme on sexuality issues that patients with breast cancer experience.
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 |
| Sexuality | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Counselling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intervention group
- interventionNames
- Other: Counselling
- type
- NO_INTERVENTION
- label
- control group
Primary outcomes (5)
- measure
- "Female Sexual Function Index"
- timeFrame
- 1.5 months
- description
- "Female Sexual Function Index" has six subscales named as desire, arousal, lubrication, orgasm, satisfaction and pain. In subscales, increasing points evaluate positively. Scores between two and thirty-six are obtained from the scale. It is found to be a valid and reliable scale. "Female Sexual Function Index" scores of breast cancer patients who receive nursing counselling for sexual problems increase after counselling programme.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * who have had primary diagnosis of breast cancer and are at stage 0-I-II, * who underwent mastectomy, * who are in full remission, receiving no other treatment except hormonal therapy, * who has been receiving hormonal treatment for at least two months and less than 5 years, * age limit is set range from 18 to 45 * who are literate and sexually active, * whose spouses had no sexual health problems, * who don't have psychiatric illness * who are capable of verbal communication and willing to participate in the study Exclusion Criteria: * who have had other cancer types or at stage III-IV * who underwent conservative breast surgery * who receive other treatment such as chemotherapy, radiotherapy * above 45 years old * who did not have sexual intercourse within the last month * whose spouses have sexual health problems * who have psychiatric illness * who are not willing to participate in the study * whose contact information could not be accessed
References
Publications (12)
- RESULTDemirci S, Eser E, Ozsaran Z, Tankisi D, Aras AB, Ozaydemir G, Anacak Y. Validation of the Turkish versions of EORTC QLQ-C30 and BR23 modules in breast cancer patients. Asian Pac J Cancer Prev. 2011;12(5):1283-7. PMID 21875283
- RESULTKedde H, van de Wiel HB, Weijmar Schultz WC, Wijsen C. Sexual dysfunction in young women with breast cancer. Support Care Cancer. 2013 Jan;21(1):271-80. doi: 10.1007/s00520-012-1521-9. Epub 2012 Jun 20. PMID 22714701
- RESULTPinto AC. Sexuality and breast cancer: prime time for young patients. J Thorac Dis. 2013 Jun;5 Suppl 1(Suppl 1):S81-6. doi: 10.3978/j.issn.2072-1439.2013.05.23. PMID 23819031
- RESULTKrebber AM, Buffart LM, Kleijn G, Riepma IC, de Bree R, Leemans CR, Becker A, Brug J, van Straten A, Cuijpers P, Verdonck-de Leeuw IM. Prevalence of depression in cancer patients: a meta-analysis of diagnostic interviews and self-report instruments. Psychooncology. 2014 Feb;23(2):121-30. doi: 10.1002/pon.3409. Epub 2013 Sep 16. PMID 24105788
- RESULTBoquiren VM, Esplen MJ, Wong J, Toner B, Warner E, Malik N. Sexual functioning in breast cancer survivors experiencing body image disturbance. Psychooncology. 2016 Jan;25(1):66-76. doi: 10.1002/pon.3819. Epub 2015 Apr 27. PMID 25916689
- RESULTMick J, Hughes M, Cohen MZ. Using the BETTER Model to assess sexuality. Clin J Oncol Nurs. 2004 Feb;8(1):84-6. doi: 10.1188/04.CJON.84-86. No abstract available. PMID 15043034
- RESULTBiglia N, Moggio G, Peano E, Sgandurra P, Ponzone R, Nappi RE, Sismondi P. Effects of surgical and adjuvant therapies for breast cancer on sexuality, cognitive functions, and body weight. J Sex Med. 2010 May;7(5):1891-900. doi: 10.1111/j.1743-6109.2010.01725.x. Epub 2010 Mar 2. PMID 20233281