Clinical Trial 23798

• Overview

  Study Title:

  Sexual Dysfunction and Related Sexual Distress in Adolescent and Young Adults with Relapsed/Refractory Large B-Cell Lymphoma and Follicular Lymphoma

  Summary:

  The purpose of the study is to determine whether the study procedures can be implemented effectively. Investigators are looking to initially assess the prevalence of sexual dysfunction and related sexual distress in adolescents and young adults (AYAs) with relapsed/refractory large B-cell lymphoma and follicular lymphoma undergoing bispecific T-cell engaging (BiTE) therapy.

  Objective:

  Aim 1: To evaluate the feasibility and acceptability of a study protocol. Aim 2: To evaluate the prevalence of sexual dysfunction and related sexual distress and determine health-related quality of life (QoL) and symptomatic adverse events (AEs) in adolescent and young adults (AYAs) who are undergoing therapy with bispecific T-cell engagers (BiTEs) before treatment and at six weeks and three months of treatment. Hypothesis: AYAs experience more sexual dysfunction, sexual distress, and symptomatic AEs and lower health-related QoL during BiTE therapy than before treatment. Aim 3: To gather insights from patients and healthcare providers at three months of treatment that will inform the development of tailored interventions, including a Sexual Health Clinic, aimed at addressing the specific sexual health needs of AYA patients with cancer. Aim 4: To integrate quantitative and qualitative findings to provide a comprehensive understanding of the sexual health issues experienced by AYAs undergoing BiTE therapy

• Inclusion Criteria

  Inclusion Criteria for Patients:
  • Age 18-39
  • Diagnosed with Large B-Cell Lymphoma and Follicular Lymphoma
  • Currently undergoing BiTE (Bispecific T-cell engager) therapy Inclusion Criteria for Health Care Providers:
  • At least one year working with this patient population

• Exclusion Criteria

  Exclusions:
  • Patients diagnosed with severe mental illness (e.g., schizophrenia, bipolar disorder, and personality disorders)
  • Providers who have been employed for less than 90 days

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