Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria
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Age ≥ 8 years
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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.
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Patients or their adult proxy must be able to sign written informed consent.
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Patients must be able to complete an electronic or written quality of life surveys
Exclusion Criteria
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Age 7 years or less.
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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.
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Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 2 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
Sponsors and Collaborators
- St. Jude Children's Research Hospital
Investigators
- Principal Investigator: Valerie Crabtree, PhD, MS, St. Jude Children's Research Hospital
- Principal Investigator: Ajay Major, MD, MS, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- NLPHLPRO
- NCI-2023-08916