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

Study Overview
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Brief Summary
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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 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
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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.

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

Conditions
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Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Participation Criteria
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Eligibility Criteria
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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 sign written informed consent. Patients must be able to complete an electronic or written 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 written informed consent.

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |