Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04695366 |
| Other study ID # |
LyPRO1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Herlev Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
In the Western world, DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL). In
Denmark, approximately 450 patients are diagnosed with DLBCL every year. Treatment with
anthracycline-based immunochemotherapy (most commonly rituximab, cyclophosphamide,
doxorubicin, vincristine and prednisone) is curative in the majority of DLBCL patients but a
significant number of patients (up to 30 %) do not achieve a complete response (CR), and an
additional subset of patients ultimately relapse after CR.
Second-line treatment with salvage chemotherapy followed by autologous hematopoietic cell
transplantation (auto-HCT) is potentially curative, therefore surveillance for relapse is
important.
Risk of relapse is declining after two years and for patients achieving event-free survival
for 24 months (post treatment), survival beyond this timepoint is close to equivalent to that
of the general population.
However optimal means of follow-up for patients with DLBCL remain controversial and have been
a somewhat overlooked and contentious issue.
Traditionally, routine follow-up in DLBCL patients consists of face-to-face meetings with a
specialist in an outpatient clinic, with varying intervals and a mixture of surveillance
components, such as clinical examinations, blood tests or imaging procedures.
To illustrate the lack of consistency in this patient group, the ESMO guidelines recommend
follow-up with 4 visits in the first year, every 6 months the next 2 years and then annually,
whereas The British Society of Hematology guidelines recommend clinical follow-up for 2 years
followed by discharge. Guidelines from the Danish Lymphoma Group (DLG) reflect the
recommendations outlined in the Lugano classification. Patients with International Prognostic
Index (IPI) 0-1 who have obtained complete remission (CR), are recommended to be followed
every 3 to 4 months the first year, then every 6 months for 2 years, without routine use of
image diagnostics. For patients with IPI> = 2, clinical follow-up is recommended every 3 to 4
months the first 2 years, then every 6 months for 3 years. CT scan is used 6, 12 and 24
months after completion of treatment.
In recent years the value of post-therapy surveillance scans in DLBCL has been questioned.
Only a minority of relapses are detected solely via imaging and no survival advantage
associated with the use of surveillance imaging has been demonstrated.
Another argument against scheduled follow-up is, that the majority of relapses are probably
identified outside the scheduled follow-up visits, and by patients themselves rather than by
the physicians.
Patient-reported outcome (PRO) data is information reported through questionnaires, directly
by patients, about how they observe symptoms, physical function and quality of life. During
recent years, PRO has experienced much attention due to the increasing evidence of the
positive effect of clinical responses to PRO measures, that are applied as intervention aids
both in terms of relieving the symptom burden, improvements in the overall psychosocial
function of the patient and survival benefits in two studies. It has been argued that the use
of PRO offers an opportunity to facilitate a transition to a more patient centred approach by
strengthening the role of patients in observing themselves. But there are several barriers
for the implementation of PRO, such as accessibility, user-friendliness, processing the
collected information, difficulties for patients having few resources and finally the
interpretation of the PRO data.
To the investigator's knowledge, no study has investigated, if collection of PRO data is
useful in detection of relapse in DLBCL or other lymphoma subtypes. As of today, most studies
in this patient group have focused on HRQOL, late-effects or unmet needs in survivorship
after treatment of lymphoma.
To solve this dilemma between ineffective, scheduled follow-up visits and the constant need
for identifying patients at risk of relapse, it has been suggested, that PRO measures offer a
potential for use by clinicians as a decision aid in identifying patients in need for
clinical consultation.
Psychosocial distress (anxiety, fear and depressive feelings) have been described to be
significant in lymphoma survivors and associated to a more frequent use of Health Care
services. One explanation is that lymphoma survivors need for psychosocial support is not met
in the current follow-up program.
Another explanation, is that there may be a psychological burden to routine surveillance and
scheduled follow-up visits in the outpatient clinic. Anxiety symptoms, depressive feelings
and fear of recurrence (FCR) in long-term lymphoma survivors are especially prevalent in the
time leading up to surveillance scans.
A fear of relapse might be a rational response after treatment of a life-threatening disease,
but FCR have been associated to lower quality of life, increased psychological distress,
dissatisfaction with care, and severe FCR even with an inferior overall survival compared
with survivors without severe FCR.
Interestingly, it has been argued whether FCR is a consequence or a cause of anxiety,
depression and lower quality of life. Maybe cancer survivors with certain anxiety traits
and/or a tendency of negative views about their health and quality of life are more at risk
of experiencing FCR during their survivorship.
Socio-demographic data such as female gender, younger age, living alone or poor social
support have been associated with increased risk of FCR, but also poorer health conditions
and advanced cancer stage (26).
To the investigator's knowledge, no study has investigated the association between
socio-demographic data, comorbidities, health literacy and psychosocial distress during
follow-up of lymphoma patients. It offers the potential to identify patients in need of more
or less support during follow-up and to move in the direction of a more personalized care of
lymphoma patients.
The aim of the study is to create a PRO questionnaire and test feasibility and the potential
to detect relapse in DLBCL patients.
In addition, PRO data is collected on patient experiences during follow-up and psychological
aspect of survivorship.
The investigator's hope for the future is to move towards a more patient centred and
individualized follow-up after treatment of lymphoma patients.
