跳至主要内容
临床试验/NCT05222282
NCT05222282进行中(未招募)不适用

Sexual Health in Patients With Hematologic Malignancies - Symptom Assessment and Management

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
110
试验地点
2
主要终点
sexual function

研究概览

简要总结

Sexual wellbeing is an integral component of psychosocial and physical wellbeing. Cancer-related symptoms, treatment side-effects and psychosocial distress have significant impact on sexual well-being and sexual health. Within the framework of sexual wellbeing, sexual function is defined by a capacity to fully engage in all phases of the human sexual response cycle. Thus, sexual dysfunction is characterized by a disruption in one or more elements of the response cycle. Previous research shows that patients with hematologic malignancies and specifically patients following stem cell transplantation experience a high symptom burden and distinct genital alterations, and therefore in increased risk of sexual dysfunction. In spite of growing evidence documenting high prevalence of sexual dysfunction in cancer patients, patients with hematologic malignancies are underrepresented in clinical trials investigating their sexual health. This study aims to examine the sexual health in patients across hematologic malignancies in Denmark, and to investigate feasiblity and effect of a randomized multimodal intervention by providing nurse-led sexual consultations and physician-led preventive genital examinations, to enhance sexual function and early recognition of gential graft versus host disease in adult patients following hematopoietic stem cell transplantation. Finally, the study aims to explore perspectives and experiences of patients following this multimodal intervention. This knowledge will entail new opportunities to detect subgroups of patients with distinct risk of sexual dysfunction, and potentially lead to targeted interventions in clinical practice toward this specific population. Moreover this will provide evidence with high methodological rigor and potentially strengthen the possibilities for evidence-based decision making in Denmark regarding preventive gential examinations during follow-up in patients following stem cell transplant.

详细描述

  1. Introduction As the survival rates for hematologic malignancies improves there is subsequently an increased need for addressing long-term complications. The evidence highlight that patients experience a high symptom burden including sexual dysfunction, and therefore in increased risk of decreased sexual health. Sexual health is a state of physical, mental and social well-being in relation to sexuality, and can reduce the emotional distress and improve psychosocial response to a cancer diagnosis and complications following treatment. Still, this population is underrepresented in clinical trials investigating their sexual health. It is therefore essential to include them in future clinical trials in order to have a comprehensive view of their condition of sexual health and sexual function. This knowledge will entail new opportunities to detect subgroups of patients with distinct risk of sexual dysfunction, and this will potentially lead to targeted interventions in clinical practice toward this specific population.

In patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) sexual dysfunction is one of the most frequent long-term issues. Sexual dysfunction include decreased libido, vaginal alterations, erectile and ejaculatory dysfunction, dysfunction in sexual hormones, dyspareunia and infertility. Specifically, an immunologic reaction in the skin tissue called genital graft versus host disease (GHVD), is a major determinant of sexual dysfunction in this population. Genital GVHD can lead to vaginal stenosis, scar tissue and adhesions in blood vessels, rash and increased sensitivity in the skin of the genitals. Despite increasing evidence on the clinical manifestations it is still an underrecognized and underestimated complication of HCST in clinical practice due to the nonspecific nature of presenting symptoms and low awareness of the condition. In a previous systematic review, the investigators concluded that multiple aspects of sexuality were affected following treatment with HSCT, and the impact and ethology of these sexual alterations were different between genders. Therefore, the investigators investigated the impact of HSCT on sexuality in a resent longitudinal survey. The results showed a significant decline in overall sexual function in both men and women. Still, most studies have solely investigated female genital GVHD, in small populations and only few have included evaluations of sexual function prior to HSCT. No previous studies have investigated the effect of a multimodal intervention specifically focused on evaluation of sexual function through nurse-led sexual consultations and early recognition of genital GVHD in patients during treatment with HSCT. Thus, further recognition of sexual symptoms and regular follow-up can possibly help to improve the detection and facilitate early treatment of sexual complications including genital GVHD. This will help our understanding in the development of systematic strategies to prevent or treat its long-term effects. 2. Hypotheses

This study is based on the following hypothesis or assumptions:

Study 1

• The investigators hypothesize that patients with hematologic malignancies report impaired sexual function, and that sexual dysfunction are associated with high symptom burden, sexual distress, reduced quality of life and increased anxiety and depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (age>18 years) with a hematologic malignancy who is planned to undergo an HSCT, who provide informed written consent and can understand, speak and read Danish are eligible to participate.

排除标准

  • The exclusion criteria include patients with dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation.

结局指标

主要结局

sexual function

时间窗: 18 month

The primary outcome is sexual function which will be assessed by Female Sexual Function Index FSFI in female participants

次要结局

  • Description of symptoms of GHVD(18 month)
  • Evaluation of quality of life in participants(18 month)
  • Evaluation of utilization of intervention(18 month)
  • Description of symptoms of genital GVHD(18 month)
  • Evaluation of safety of intervention(18 month)
  • Evaluation of practicability of intervention(18 month)
  • Evaluation of integration of intervention(18 month)
  • Evaluation of Symptom burden(18 month)
  • Evaluation of acceptability of intervention(18 month)
  • Evaluation of Sexual distress(18 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristina Holmegaard Nørskov

Clinical Nurse Specialist, PhD

Rigshospitalet, Denmark

研究点 (2)

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