Clinical trial NCT04297657: Using BETTER Model Sexual Problems in Breast Cancer
Official title: THE EFFECT OF BETTER MODEL COUNSELLING WITH MODEL OVER SEXUAL PROBLEMS OF WOMEN WITH BREAST CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexuality
Breast Cancer
Keywords: breast cancer
sexuality
better model
nursing care
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre evaluation-final evaluation, control group work
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Methods: The sampling consists of 60 female participants who volunteered to participate in the study. Face to face interviews are held with the female participants based on the Information Forms and Female Sexual Function Index (FSFI)", "EORTC QLQ-BR23 Quality of Life Questionnaire", "Center for Epidemiologic Studies Depression Scale (CES-D)", "Body Cathexis Scale (BCS)" and "BETTER Model". Counselling programme of the women in the intervention group is held in four sessions one week apart and these women are provided with a counselling booklet accompanied by a CD. The scales are re-applied one month after the last session. In the control group, the women are left under routine hospital control after the scales are applied. The scales are re-applied to the control group after one month.

Eligibility criteria: 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

Primary outcomes:
measure: "Female Sexual Function Index"
timeFrame: 1.5 months
measure: the functional scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"
timeFrame: 1.5 months
measure: "Body Cathexis Scale"
timeFrame: 1.5 months
measure: "Center for Epidemiologic Studies Depression Scale"
timeFrame: 1.5 months
measure: The symptom scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"
timeFrame: 1.5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University
name: Zeynep Olcer
role: PRINCIPAL_INVESTIGATOR
References:
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