The Potential of Patient-reported Outcome Measures in Detection of Relapse in Diffuse Large B-cell Lymphoma

NCT04695366 | Completed DMC

• 1 other identifier: LyPRO1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Diffuse Large B Cell Lymphoma; Patient Reported Outcome

Keywords

follow-up; surveillance; feasibility

Outcome Measures

Primary Outcomes (1)

• Correlation between each item in the questionnaire or groups of items and subsequent relapse

  indicators of relapse.

  2 years

Secondary Outcomes (3)

• Impact of routine follow-up on psychological distress

  2 years

• Impact of personality on psychological distress

  2 years

• Feasibility testing of electronic use of questionnaires in DLBCL patients

  2 years

Study Arms (1)

Diffuse large B-cell lymphoma patients in year 1 and 2 of clinical follow-up

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Diffuse large B-cell lymphoma patients in year 1 and 2 of clinical follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From 1 January 2021 to 31 December 2022, we will invite all DLBCL patients in remission after first-line curative treatment provided at the hematology departments of Herlev hospital, Universtity of Copenhagen, and Rigshospitalet, University of Copenhagen, to participate.

You may qualify if:

• DLBCL diagnosed according to the WHO classification
• Age \>18 years at diagnosis
• 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.
• Participated in less than 2 years of follow-up without biopsy-verified relapse
• Access to electronic communication with health authorities (e-Boks - an electronic, closed two factor authentication)
• Able to receive an email and complete a questionnaire in Danish

You may not qualify if:

• Verified lymphoma in the central nervous system (CNS)
• Initial treatment not completed
• CR not reached after initial treatment
• Palliative treatment including attenuated chemotherapy
• Undergoing anti-lymphoma treatment or treatment for other cancer.
• Inability to read Danish or no access to electronic communication

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Therese Lassen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Therese Lassen, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Head of research, PhD, MD

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 5, 2021
• Study Start: February 10, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)