RecruitingObservational

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

NCT ID: NCT06098430Sponsor: St. Jude Children's Research HospitalLast updated: 2026-05-20

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.

Outcome measures

Primary

Estimates of response rates
Percentage of survey completion at different timepoints
Time frame: 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.
Time frame: At baseline, 3, 6, 9, and 12 months

Eligibility criteria

Sex: AllAge: 8 Years and olderHealthy 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.

Study locations (7)

Stanford University Medical Center

Palo Alto, California, 94304

Recruiting

Michael Binkley, MD · Contact

650-736-0921 msb996@stanford.edu

Michael Binkley, MD · Principal Investigator

University of Colorado Hospital

Aurora, Colorado, 80045

Recruiting

Ajay Major, MD, MBA · Contact

720-848-0300 ajay.major@cuanschutz.edu

Ajay Major, MD, MBA · Principal Investigator

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Angela Feraco, MD · Contact

888-733-4662 Angela_Feraco@dfci.harvard.edu

Angela Feraco, MD · Principal Investigator

Hackensack University Medical Center

Hackensack, New Jersey, 08837

Recruiting

Burton Appel, MD, MBA · Contact

551-996-5437 burton.appel@hmhn.org

Burton Appel, MD, MBA · Principal Investigator

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Christopher Forlenza, MD · Contact

212-639-5226 Forlenzc@MSKCC.org

Christopher Forlenza, MD · Principal Investigator

University of Rochester Medical Center

Rochester, New York, 14642

Recruiting

Jamie Flerlage, MD, MS · Contact

585-275-2981 jamie_flerlage@urmc.rochester.edu

Jamie Flerlage, MD, MS · Principal Investigator

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Recruiting

Valerie Crabtree, PhD · Contact

888-226-4343 referralinfo@stjude.org

Jessi Rogers Blake, BSN,RN,CCRP · Contact

901-595-4108 jessi.rogers-blake@stjude.org

Valerie Crabtree, PhD · Principal Investigator

Anna Jones, PhD · Principal Investigator

Matthew Rees, MD · Principal Investigator