Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Conditions
Brief 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.
Interventions
None listed
Sponsors
St. Jude Children's Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimates of response rates | At baseline, 3, 6, 9, and 12 months | Percentage of survey completion at different timepoints |
| Patterns of individual per-patient survey completion | At baseline, 3, 6, 9, and 12 months | 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. |
Countries
United States
Contacts
CONTACTValerie Crabtree, PhD
CONTACTJessi Rogers Blake, BSN,RN,CCRP
PRINCIPAL_INVESTIGATORValerie Crabtree, PhD
St. Jude Children's Research Hospital
PRINCIPAL_INVESTIGATORAjay Major, MD, MBA
University of Colorado, Denver
PRINCIPAL_INVESTIGATORAnna Jones, PhD
St. Jude Children's Research Hospital
PRINCIPAL_INVESTIGATORMatthew Rees, MD
St. Jude Children's Research Hospital
PRINCIPAL_INVESTIGATORJamie Flerlage, MD, MS
University of Rochester
Outcome results
None listed