Sexual Health in Patients With Hematologic Malignancies

NCT05222282 | Unknown DMC

• 1 other identifier: Sexual Health
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sexual health; hematologic malignancy; sexual dysfunction; quality of life; symptom assessment; symptom management

Outcome Measures

Primary Outcomes (2)

• sexual function

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

  18 month

• sexual function

  The primary outcome is sexual function which will be assessed by The International Index of Erectile Function Questionnaire IIEF in male patients

  18 month

Secondary Outcomes (10)

• Evaluation of acceptability of intervention

  18 month

• Evaluation of practicability of intervention

  18 month

• Evaluation of integration of intervention

  18 month

• Evaluation of utilization of intervention

  18 month

• Evaluation of safety of intervention

  18 month

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention with 1. nurseled sexual consultations with screening questionnaire prior to consultation 2. genital examintaion with doctor

Other: Sexual Health

Kontrol

OTHER

Usual care

Other: Sexual Health

Interventions

Sexual Health OTHER

Prevention of sexual dysfunction

Intervention; Kontrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Kristina Nørskov

Copenhagen, 1234, Denmark

Location

Related Publications (1)

• Norskov KH, Schjoedt I, Tolver A, Jarden M. Sexual health in patients with malignant hematological disease: a Danish cross-sectional study. Sex Med. 2024 Sep 13;12(4):qfae053. doi: 10.1093/sexmed/qfae053. eCollection 2024 Aug.

  PMID: 39281809 DERIVED

MeSH Terms

Conditions

Sexuality; Sexual Dysfunction, Physiological; Signs and Symptoms; Hematologic Neoplasms

Interventions

Sexual Health

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Genital Diseases; Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist, PhD

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 3, 2022
• Study Start: May 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

DK (1)