Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)

A Pilot Study of Prospective Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)

There is a pressing need to measure patient-reported symptoms in patients of all ages diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). This study aims to measure longitudinal symptom burden and treatment tolerability utilizing validated patient-reported outcomes (PROs) instruments.

Primary Objective:

• To develop the data collection infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (PROs) survey instruments in adult and pediatric patients diagnosed with NLPHL.

Secondary Objective:

• To examine differences in baseline and longitudinal changes in PROs based on disease characteristics, disease status, and treatment strategies among adult and pediatric patients diagnosed with NLPHL.

Study Overview

• Status: Recruiting
• Conditions: Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Detailed Description

The broad aim of this study is to develop the foundational data management infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (PROs) survey instruments in adult and pediatric patients diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The study team further aims to elucidate how PROs change over time and how they may be affected by different patient, disease, and treatment characteristics.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Valerie Crabtree, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
• Study Contact Backup: Name: Jessi Rogers Blake, BSN, RN,CCRP; Phone Number: 901-595-4108; Email: jessi.rogers-blake@stjude.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • University of Colorado Hospital
      • Contact: Ajay Major, MD, MBA; Phone Number: 720-848-0300; Email: ajay.major@cuanschutz.edu
      • Principal Investigator: Ajay Major, MD, MBA
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Phone Number: 866-278-5833; Email: referralinfo@stjude.org
      • Principal Investigator: Valerie Crabtree, PhD
      • Principal Investigator: Anna Jones, PhD
      • Principal Investigator: Matthew Rees, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that meet eligibility

Description

Inclusion Criteria

• Age ≥ 8 years
• Pathologically confirmed diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL); patients with evidence of transformed lymphoma at diagnosis or subsequent development of transformed lymphoma after diagnosis are eligible.
• Patients or their adult proxy must be able to provide consent.
• Patients and/or adult proxy must be able to complete electronic quality of life surveys

Exclusion Criteria

• Age 7 years or less.
• Patients with histologic evidence of a composite lymphoma (NLPHL with a concurrent diagnosis of Hodgkin lymphoma, indolent non-Hodgkin lymphoma, or gray zone lymphoma) at diagnosis are not eligible.
• Inability or unwillingness of research participant or legal guardian/representative to give consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimates of response rates	Percentage of survey completion at different timepoints	At baseline, 3, 6, 9, and 12 months
Patterns of individual per-patient survey completion	Patterns of individual per-patient survey completion will be described. Non-responders, late responders, and patients with suboptimal item completion rates who require real-time outreach will be queried for individual challenges in completing PRO surveys for iterative improvements to infrastructure.	At baseline, 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Ajay Major, MD, MS, University of Colorado, Denver; Principal Investigator: Valerie Crabtree, PhD, St. Jude Children's Research Hospital; Principal Investigator: Anna Jones, PhD, St. Jude Children's Research Hospital; Principal Investigator: Matthew Rees, MD, St. Jude Children's Research Hospital; Principal Investigator: Jamie Flerlage, MD, MS, University of Rochester

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: NLPHLPRO; NCI-2023-08916 (Registry Identifier: NCI Clinical Trial Registration Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No