Sexual Health in Patients With Hematologic Malignancies

NCT05222282 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-09-28

No results posted yet for this study

Summary

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.

Conditions

  • Sexuality
  • Sexual Dysfunction
  • Psychological
  • Quality of Life
  • Symptoms and Signs

Interventions

OTHER

Sexual Health

Prevention of sexual dysfunction

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-11-01
Completion
2025-01-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222282 on ClinicalTrials.gov