Clinical trial · Observational
The Potential of Patient-reported Outcome Measures in Detection of Relapse in Diffuse Large B-cell Lymphoma
The Potential of Patient-reported Outcome Measures in Detection of Relapse in Diffuse Large B-cell Lymphoma - a Prospective Cohort 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)
Annually some 450 patients are diagnosed with Diffuse Large B-cell Lymphoma (DLBCL), in Denmark. The majority of these patients are cured with immunochemotherapy, but up to 30 % will relapse, pointing to the need for targeted surveillance and follow-up strategy. However, this strategy is constantly under debate illustrated by the missing data supporting scheduled face-to-face meetings with a clinician and routine surveillance scans in order to detect relapse. On top of the clinical problems comes the psychological burden for patients enrolled in routine surveillance. This points to the need for the development of evidence-based follow-up programs both in terms of content, regularity and assignment of responsibility between the health system and the patient. In a prospective cohort study, the investigators will collect Patient Reported Outcome (PRO) measures investigating if questionnaires can be used to detect relapse in DLBCL patients. Furthermore psychological aspects of follow-up are explored.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Patient Reported Outcome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diffuse large B-cell lymphoma patients in year 1 and 2 of clinical follow-up
- description
- Patients (Diffuse Large B-cell Lymphoma) in complete remission after primary treatment and entering the regular follow-up program at the clinic. Baseline is defined as date of end-of-treatment visit.
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Correlation between each item in the questionnaire or groups of items and subsequent relapse
- timeFrame
- 2 years
- description
- indicators of relapse.
Secondary outcomes (3)
- measure
- Impact of routine follow-up on psychological distress
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. DLBCL diagnosed according to the WHO classification 2. Age \>18 years at diagnosis 3. Completed curative intent first line treatment with anthracycline-containing immuno-chemotherapy with or without consolidating radiotherapy and achieved CR on end-of-treatment CT/PET-CT scan, as recorded in the medical record by the treating physician. 4. Participated in less than 2 years of follow-up without biopsy-verified relapse 5. Access to electronic communication with health authorities (e-Boks - an electronic, closed two factor authentication) 6. Able to receive an email and complete a questionnaire in Danish Exclusion Criteria: 1. Verified lymphoma in the central nervous system (CNS) 2. Initial treatment not completed 3. CR not reached after initial treatment 4. Palliative treatment including attenuated chemotherapy 5. Undergoing anti-lymphoma treatment or treatment for other cancer. 6. Inability to read Danish or no access to electronic communication
References
Publications (0)
Data not yet available