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Trial Title:
Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)
NCT ID:
NCT06098430
Condition:
Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
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.
Criteria for eligibility:
Study pop:
Patients that meet eligibility
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria
- Age ≥ 8 years
- Patient or their adult proxy must have verbal and written English language
proficiency.
- 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.
- Patient or adult proxy does not have verbal and written English language
proficiency.
- 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.
Gender:
All
Minimum age:
8 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ajay Major, MD, MBA
Phone:
720-848-0300
Email:
ajay.major@cuanschutz.edu
Investigator:
Last name:
Ajay Major, MD, MBA
Email:
Principal Investigator
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Phone:
866-278-5833
Email:
referralinfo@stjude.org
Investigator:
Last name:
Valerie Crabtree, PhD
Email:
Principal Investigator
Investigator:
Last name:
Anna Jones, PhD
Email:
Principal Investigator
Investigator:
Last name:
Matthew Rees, MD
Email:
Principal Investigator
Start date:
April 4, 2024
Completion date:
January 31, 2028
Lead sponsor:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Source:
St. Jude Children's Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06098430
http://www.stjude.org
http://www.stjude.org/protocols
