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Completed

NCT Number: NCT04297657

Using BETTER Model Sexual Problems in Breast Cancer

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.

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Key information

Conditions

Sexuality Behavior Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Sexual Behavior Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counselling

Other

o An appointment was made with the women in the experimental group at a time when they were available and a suitable environment was arranged in the hospital. The counselling programme of the experimental group was conducted in four sessions one week apart. In addition, each woman in the experimental group was given a counselling booklet and compact disc. The interviews lasted between 15- 45 minutes. The topics of interest among women were noted in the interviews and after the information on the subject was received, feedback was given to the relevant woman through a phone call.

Other names: education

Primary outcomes

  1. "Female Sexual Function Index"

    Time frame: 1.5 months

    "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.

  2. the functional scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"

    Time frame: 1.5 months

    "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23" consists of 23 questions that look into the side effects of breast cancer treatments, body image, sexuality and future expectations. Scores between zero and one hundred points could be obtained from the scale. In Functional Scale increasing points evaluate positively. It is found to be a valid and reliable scale. The functional scale scores of the"European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23" of breast cancer patients who receive nursing counselling for sexual problems increase after counselling programme.

  3. "Body Cathexis Scale"

    Time frame: 1.5 months

    This 40-item scale aims to measure the degree of happiness among people regarding their body sections and functions. Scores between 40 and 200 points can be obtained from the scale. This scale has no cut-off point. The high scores received indicate a high degree of satisfaction. Validity and reliability study for this scale is conducted in our country. "Body Cathexis Scale" scores of breast cancer patients who receive nursing counselling for sexual problems increase after counselling programme.

  4. "Center for Epidemiologic Studies Depression Scale"

    Time frame: 1.5 months

    The scale consists of 20 items and four subscales on depression-related symptoms during a one week period. The total score that can be received from the scale vary between 0 and 60, with 16 points and above suggesting the probability of depression.It is a valid and reliable scale that is frequently used in cancer patients. "Center for Epidemiologic Studies Depression Scale" scores of breast cancer patients who receive nursing counselling for sexual problems decrease after the counselling programme.

  5. The symptom scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"

    Time frame: 1.5 months

    "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23" consists 23 questions that look into the side effects of breast cancer treatments, body image, sexuality and future expectations. Scores between zero and one hundred points could be obtained from the scale. In the Symptom Scales/Items decreasing points evaluate positively. It is found to be a valid and reliable scale. The symptom scale scores of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23" of breast cancer patients who receive nursing counselling for sexual problems decrease after the counselling programme.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

THE EFFECT OF BETTER MODEL COUNSELLING WITH MODEL OVER SEXUAL PROBLEMS OF WOMEN WITH BREAST CANCER

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2020
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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