ClinicalTrials.gov record NCT07173790
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study asks people with indolent lymphomas who are being managed with watch-and-wait to complete validated quality-of-life and distress questionnaires once during a routine outpatient visit. The study also pulls basic clinical and demographic data from medical records. No treatment is given; completing the survey takes about 20–30 minutes. It aims to describe quality of life and emotional well-being in this patient group.
What it is studying. Whether and how observation (watch-and-wait) is associated with patient-reported quality of life, psychological distress, and emotional well-being in people with indolent lymphomas.
What the researchers hope to learn. To measure and describe quality of life, symptoms, and psychosocial distress in people with indolent lymphoma managed with watch-and-wait; to provide data specific to the study population and healthcare context; and to inform future research and clinical understanding.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Patient-Reported Outcomes Survey
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
This is an observational, patient-reported outcomes study of indolent lymphoma patients managed with a watch-and-wait strategy. Eligible participants include adults (≥19 years) diagnosed at Seoul National University Hospital with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), or Waldenström macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL), according to WHO criteria. Patients must be recently diagnosed, currently under observation, and able to understand and complete the survey independently. Patients receiving active systemic therapy or with cognitive impairment precluding self-report are excluded. The target enrollment is up to 150 participants, estimated based on the number of eligible outpatients seen over a 3-month period. Recruitment will occur during outpatient visits, where physicians will introduce the study. After providing written informed consent, patients will complete validated questionnaires (EORTC QLQ-C30, EQ-5D-5L, and disease-specific modules such as QLQ-CLL17 or QLQ-NHL) to assess quality of life, distress, and emotional well-being. Clinical and demographic data (e.g., age, sex, diagnosis, stage, ECOG, marital status, outpatient interval) will also be collected from medical records. Surveys are expected to take at least 20 minutes and will be completed by patients during outpatient waiting periods. The study involves no therapeutic intervention and poses no risks beyond minimal psychological burden comparable to daily life or routine clinical assessments. Data will be analyzed descriptively and statistically to evaluate the impact of observation on quality of life and psychosocial outcomes. Unlike prior studies, this investigation will focus on Korean patients, reflecting Asian cultural context, local health insurance structure, and treatment accessibility, thereby providing novel and clinically meaningful insights.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving written consent, participants complete validated questionnaires once during a routine outpatient visit (EORTC QLQ-C30, EQ-5D-5L, and disease-specific modules such as QLQ-CLL17 or QLQ-NHL). The survey takes about 20–30 minutes and is expected to be done during waiting periods. Study staff will also collect clinical and demographic information from medical records. There is no study treatment; the visit involves only questionnaires and record review and poses minimal additional burden beyond routine clinic care.
How the study is structured. Observational, cross-sectional cohort study. Participants complete validated questionnaires (EORTC QLQ-C30, EQ-5D-5L, and disease-specific modules) once during a routine outpatient visit; researchers also collect basic clinical and demographic information from medical records. No treatment is assigned; the assessment is a single visit/day.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Oct 1, 2025
- Primary completion
- Sep 10, 2027 (estimated)
- Study completion
- Sep 10, 2027 (estimated)
- Target enrollment
- 250 participants (estimated)
- Last updated on registry
- Nov 21, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Seoul National University Hospital
- Principal investigator
- JaMin Byun, Professor of Hematology/Oncology
Seoul National University Hospital - Collaborators
- Korea University Anam Hospital
- Samsung Medical Center
- Catholic Medical Center of Korea
Participating sites (4)
- Samsung Medical Center
Seoul, Gangnam-gu, 06351 · South Korea
- Korea UniversityKorea University Guro Hospital
Seoul, Guro-gu, 08308 · South Korea
- Seoul National University Hospital
Seoul, Jongno-gu · South Korea
- The Catholic University of Korea
Seoul, Seocho-gu, 06591 · South Korea
Terms used on this page · explanations by MedicalUpdates.ai
- overall survival
- The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- ECOG
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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