Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nodular Lymphocyte-Predominant Hodgkin Lymphoma. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study of Prospective Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)
Overview
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.
Primary outcome measures
- Estimates of response rates [Time frame: At baseline, 3, 6, 9, and 12 months]
- Patterns of individual per-patient survey completion [Time frame: At baseline, 3, 6, 9, and 12 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Stanford University Medical Center — Palo Alto
- University of Colorado Hospital — Aurora
- Dana-Farber Cancer Institute — Boston
- Hackensack University Medical Center — Hackensack
- Memorial Sloan Kettering Cancer Center — New York
- University of Rochester Medical Center — Rochester
- St. Jude Children's Research Hospital — Memphis
Identifiers
NCT: NCT06098430 · NLPHLPRO · NCI-2023-08916