search
Back to results

Using BETTER Model Sexual Problems in Breast Cancer

Primary Purpose

Sexuality, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Counselling
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sexuality focused on measuring breast cancer, sexuality, better model, nursing care

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    "Female Sexual Function Index"
    "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.
    the functional scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"
    "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.
    "Body Cathexis Scale"
    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.
    "Center for Epidemiologic Studies Depression Scale"
    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.
    The symptom scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"
    "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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2020
    Last Updated
    March 4, 2020
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04297657
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 28, 2016 (Actual)
    Primary Completion Date
    April 6, 2018 (Actual)
    Study Completion Date
    April 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sexuality, Breast Cancer
    Keywords
    breast cancer, sexuality, better model, nursing care

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    pre evaluation-final evaluation, control group work
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Counselling
    Other Intervention Name(s)
    education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    "Female Sexual Function Index"
    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.
    Time Frame
    1.5 months
    Title
    the functional scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"
    Description
    "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.
    Time Frame
    1.5 months
    Title
    "Body Cathexis Scale"
    Description
    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.
    Time Frame
    1.5 months
    Title
    "Center for Epidemiologic Studies Depression Scale"
    Description
    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.
    Time Frame
    1.5 months
    Title
    The symptom scale of the "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast 23"
    Description
    "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.
    Time Frame
    1.5 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zeynep Olcer
    Organizational Affiliation
    Istanbul University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21875283
    Citation
    Demirci 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.
    Results Reference
    result
    PubMed Identifier
    22714701
    Citation
    Kedde 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.
    Results Reference
    result
    PubMed Identifier
    23819031
    Citation
    Pinto 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.
    Results Reference
    result
    PubMed Identifier
    24105788
    Citation
    Krebber 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.
    Results Reference
    result
    PubMed Identifier
    25916689
    Citation
    Boquiren 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.
    Results Reference
    result
    PubMed Identifier
    15043034
    Citation
    Mick 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.
    Results Reference
    result
    PubMed Identifier
    20233281
    Citation
    Biglia 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.
    Results Reference
    result
    PubMed Identifier
    21199377
    Citation
    Panjari M, Bell RJ, Davis SR. Sexual function after breast cancer. J Sex Med. 2011 Jan;8(1):294-302. doi: 10.1111/j.1743-6109.2010.02034.x. Epub 2010 Sep 23.
    Results Reference
    result
    PubMed Identifier
    20885305
    Citation
    Jun EY, Kim S, Chang SB, Oh K, Kang HS, Kang SS. The effect of a sexual life reframing program on marital intimacy, body image, and sexual function among breast cancer survivors. Cancer Nurs. 2011 Mar-Apr;34(2):142-9. doi: 10.1097/NCC.0b013e3181f1ab7a.
    Results Reference
    result
    PubMed Identifier
    26353787
    Citation
    Perz J, Ussher JM; Australian Cancer and Sexuality Study Team. A randomized trial of a minimal intervention for sexual concerns after cancer: a comparison of self-help and professionally delivered modalities. BMC Cancer. 2015 Sep 9;15:629. doi: 10.1186/s12885-015-1638-6.
    Results Reference
    result
    PubMed Identifier
    25377349
    Citation
    Rush CL, Darling M, Elliott MG, Febus-Sampayo I, Kuo C, Munoz J, Duron Y, Torres M, Galvan CC, Gonzalez F, Caicedo L, Napoles A, Jensen RE, Anderson E, Graves KD. Engaging Latina cancer survivors, their caregivers, and community partners in a randomized controlled trial: Nueva Vida intervention. Qual Life Res. 2015 May;24(5):1107-18. doi: 10.1007/s11136-014-0847-9. Epub 2014 Nov 8.
    Results Reference
    result
    PubMed Identifier
    28427439
    Citation
    Kim GM, Kim SJ, Song SK, Kim HR, Kang BD, Noh SH, Chung HC, Kim KR, Rha SY. Prevalence and prognostic implications of psychological distress in patients with gastric cancer. BMC Cancer. 2017 Apr 20;17(1):283. doi: 10.1186/s12885-017-3260-2.
    Results Reference
    result

    Learn more about this trial

    Using BETTER Model Sexual Problems in Breast Cancer

    We'll reach out to this number within 24 hrs