Clinical trial · Observational
Watch and Wait or Worry and Wait in Indolent Lymphoma
Indolent Lymphoma: Is "Watch and Wait" Really "Worry and Wait"? A Patient-Reported Outcomes Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Indolent lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma, marginal zone lymphoma, low-grade follicular lymphoma, and Waldenström macroglobulinemia, are slow-growing cancers often managed initially with a watchful waiting strategy. This approach avoids unnecessary side effects of early therapy but may negatively impact patients' quality of life (QoL) due to anxiety, uncertainty, and self-monitoring of symptoms. Previous research has suggested increased distress and greater QoL decline in patients under observation compared to those receiving treatment, despite similar or lower disease burden. Moreover, poor QoL has been shown to independently predict overall survival in non-Hodgkin lymphoma patients. However, there are limited data from Asian populations, where cultural factors, health insurance systems, and treatment access differ significantly. This study will evaluate the impact of watchful waiting on patient-reported QoL among Korean patients with indolent lymphoma, providing evidence specific to this population and healthcare setting.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) | Small Lymphocytic Lymphoma | ALIAS | 0.85 |
| Follicular Lymphoma, Grade 1 | Grade 1 Follicular Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma, Grade 2 | Grade 2 Follicular Lymphoma | ALIAS | 0.90 |
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma(MZL) | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Waldenström Macroglobulinemia (WM) | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Reported Outcomes Survey | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- observational cohort
- description
- Patients with indolent lymphoma (CLL/SLL, MZL, FL, WM/LPL) who are recently diagnosed and managed with a watch-and-wait strategy. Participants will complete patient-reported outcome surveys assessing quality of life and psychological distress.
- interventionNames
- Other: Patient-Reported Outcomes Survey
Primary outcomes (1)
- measure
- Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
- timeFrame
- At enrollment during a routine outpatient visit for patients managed with watch-and-wait; single assessment completed once on the day of enrollment (expected 20-30 minutes).
- description
- Patient-reported quality of life will be measured using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), which includes global health status/QoL, functional scales, and symptom items. Scores will be transformed to a 0-100 scale according to the official EORTC scoring manual; higher functional and global health scores indicate better quality of life, whereas higher symptom scores indicate worse symptoms.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adults ≥19 years old. * Diagnosed with indolent lymphoma (CLL/SLL, MZL, FL, or WM/LPL) at Seoul National University Hospital according to WHO criteria. * Currently managed with watch-and-wait (no active systemic therapy). * Able to understand and independently complete the study questionnaires. * Provide voluntary informed consent. Exclusion Criteria: * Receiving active systemic anti-lymphoma therapy at the time of enrollment. * Cognitive impairment or other condition preventing independent completion of the questionnaire.
References
Publications (3)
- RESULTAkkad N, Flowers CR. Patient-Reported Outcome Measures (PROMS) in Lymphoma. Curr Oncol. 2025 May 1;32(5):265. doi: 10.3390/curroncol32050265. PMID 40422524
- RESULTTsang M, Maurer MJ, Habermann TM, Cerhan JR, Nastoupil LJ, McCaughan G, et al. Longitudinal assessment of quality of life (QoL) among patients with follicular lymphoma (FL) according to frontline management strategy and FLIPI risk: Analysis from the LEO Cohort. Presented at: 65th American Society of Hematology (ASH) Annual Meeting; 2023 Dec 9-12; San Diego, CA. Abstract 188382
- RESULTMcCaughan D, Roman E, Sheridan R, Hewison A, Smith AG, Patmore R, Howell DA. Patient perspectives of 'Watch and Wait' for chronic haematological cancers: Findings from a qualitative study. Eur J Oncol Nurs. 2023 Aug;65:102349. doi: 10.1016/j.ejon.2023.102349. Epub 2023 May 13. PMID 37331194