NCT07173790

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Oct 2025

Geographic Reach
1 country

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Oct 2025Sep 2027

First Submitted

Initial submission to the registry

September 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2027

Last Updated

November 21, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

September 8, 2025

Last Update Submit

November 18, 2025

Conditions

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)Marginal Zone Lymphoma(MZL)Follicular Lymphoma, Grade 1Follicular Lymphoma, Grade 2Waldenström Macroglobulinemia (WM)Lymphoplasmacytic Lymphoma

Keywords

Indolent lymphomaPROWatch and WaitPatient-Reported OutcomesQuality of Life (QoL)Psychosocial Distress

Outcome Measures

Primary Outcomes (1)

  • Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    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.

    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).

Study Arms (1)

observational cohort

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.

Other: Patient-Reported Outcomes Survey

Interventions

Patient-Reported Outcomes SurveyOTHER

Participants will complete validated questionnaires including EORTC QLQ-C30, EQ-5D-5L, and disease-specific modules (QLQ-CLL17, QLQ-NHL). Responses will be used to assess quality of life and psychological distress during watchful waiting.

observational cohort

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with indolent lymphoma (CLL/SLL, MZL, FL, or WM/LPL) at Seoul National University Hospital who are managed with a watch-and-wait strategy and able to provide informed consent and complete patient-reported outcome surveys.

You may qualify if:

  • 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.

You may not qualify if:

  • Receiving active systemic anti-lymphoma therapy at the time of enrollment.
  • Cognitive impairment or other condition preventing independent completion of the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Korea UniversityKorea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Location

The Catholic University of Korea

Seoul, Seocho-gu, 06591, South Korea

Location

Related Publications (3)

  • Akkad N, Flowers CR. Patient-Reported Outcome Measures (PROMS) in Lymphoma. Curr Oncol. 2025 May 1;32(5):265. doi: 10.3390/curroncol32050265.

    PMID: 40422524RESULT

  • Tsang 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

    RESULT

  • McCaughan 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: 37331194RESULT

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularWaldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Ja Min Byun, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Hematology/Oncology

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 15, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

September 10, 2027

Last Updated

November 21, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared in order to protect patient confidentiality, as the dataset contains sensitive clinical and patient-reported information. Only aggregate results will be disseminated through publications and presentations.

Locations

KR(4)