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OpenTrials
Completed

NCT Number: NCT03408769

Metastatic Breast Carcinoma and Women Sexual Quality of Life

Sexual health is one of the relevant parameters for assesing the quality of life.

Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.

The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.

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Key information

Conditions

Metastatic Breast Carcinoma Behavior Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Sexual Behavior Sexuality Skin Diseases Skin and Connective Tissue Diseases pseudofolliculitis barbae

Age range

50 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

About this study

We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires.

The sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with metastatic breast cancer
  • Age ≥ 50 and < 70 years old
  • Diagnosis of metastatic breast cancer at least 6 months prior to study participation
  • Patient living with a partner
  • Menopausal women (absence of menstruation for 1 year minimum)
  • ECOG performance status ≤ 2
  • Affiliated to public health system
  • Informed and having expressed her non-opposition

Exclusion criteria

  • Patient in exclusive palliative care
  • Single or not living in a couple
  • Non-menopausal patient

Treatment and study plan

Medical questionnaire

Other
  • Brief Index of Sexual Functioning for Women questionnaire
  • Quality of life questionnaire (EORTC QLQ-BR23)
  • Partnership questionnaire (partnerschaftsfragebogen; PFB)
  • Short interview about their sexual intimacy

Primary outcomes

  1. Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples

    Time frame: 1 day

    Quality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire

Secondary outcomes

  1. Quality of life

    Time frame: 1 day

    Quality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014)

  2. Quality of Relationship of the couple

    Time frame: 1 day

    Quality of Relationship of the couple will assessed by partnership questionnaire (PFB). 30 items making up a global scale measuring the Quality of relationship (PFB).Quality of relationship (PFB) score can be obtained with the following equation: PFB = (30 - Quarreling) + Tenderness + Togetherness/communication ( Rossier et al, 2006).

  3. Sexual and emotional intimacy

    Time frame: 1 day

    Patients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life

Acronym: SexoMBC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Aug 8, 2018

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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