The main objective is to assess HRQoL and (disease-specific) symptoms in patients with lymphoma or multiple myeloma. In addition, to identify demographic, clinical, biological, physiological and environmental characteristics of lymphoma and multiple…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's unspecified histology
- Lymphomas non-Hodgkin's unspecified histology
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: HRQoL (EORTC QLQ-C30) and disease specific HRQoL/symptoms (EORTC
QLQ-LYMPH32 or EORTC QLQ-MY20 + 2 single items from EORTC item library)
Secondary outcome
Secondary: neuropathy (single item from EORTC item library), sexual
functioning/intimacy (5 single items from EORTC item library), anxiety and
depressive symptoms (HADS), side effects (PRO-CTC-AE), personality (LOT-R and
BFI), self-management (HEIQ), coping (SE7), health status (EQ-5D), therapy
adherence (MARS) and health-care use.
Background summary
Currently in the Netherlands, 44.500 patients live with or have survived
lymphoma or multiple myeloma (20-years prevalence). Health-related quality of
life (HRQoL) after cancer diagnosis and treatment has become more important
over the years in these patients because of a favourable survival. In addition,
indolent non-Hodgkin lymphoma and chronic lymphatic leukaemia (CLL) are
generally regarded more of a chronic disease, remaining present over many years
after diagnosis. Previous research identified HRQoL varied by age, sex,
comorbid diseases, and the presence of late effects. Besides, several studies
indicated lower physical functioning, cognitive functioning, psychological
distress, and problems concerning sexuality, fatigue, appetite loss, vitality,
and finances in patients with lymphoma. However, the majority of studies about
HRQoL in lymphoma or multiple myeloma is cross-sectional in design, and insight
in underlying mechanisms of HRQoL, relying best on longitudinal study designs,
is lacking. This study builds upon an ongoing longitudinal study by our
research group, assessing HRQoL in lymphoma and multiple myeloma patients from
diagnosis to two years after diagnosis, including questionnaires and the Fitbit
Inspire (NL20.011). In order to investigate the mechanisms leading to worse QoL
outcomes among lymphoma and multiple myeloma patients more thoroughly, we now
also aim to include measurements of side effects during active treatment
(BijKankerApp), biological factors (blood samples) and environmental factors
(food intake).
Study objective
The main objective is to assess HRQoL and (disease-specific) symptoms in
patients with lymphoma or multiple myeloma. In addition, to identify
demographic, clinical, biological, physiological and environmental
characteristics of lymphoma and multiple myeloma patients who are at high risk
for poor physical and psychosocial outcomes (general and disease-specific QoL,
physical activity, anxiety, depression, health care utilisation, therapy
adherence and sleep).
The main research questions of our longitudinal population-based study are:
1. What is the level of HRQoL and symptoms of patients diagnosed with lymphoma
or multiple myeloma before, during and up to two years after treatment?
2. What is the role of demographic (age, gender), clinical (disease
characteristics, treatment, side effects), physiological (daily activity, heart
rate, sleep), biological (blood samples) and environmental (Body Mass Index,
food intake) characteristics on HRQoL of lymphoma and multiple myeloma patients
and can we identify individuals or groups at risk of lower HRQoL?
3. What is the association of mediating mechanisms (e.g. inflammation levels,
body composition, heart rate, physical activity) with poor physical and
psychosocial outcomes in lymphoma and multiple myeloma patients? In other
words, why is a person at risk?
Study design
Longitudinal population-based study.
Study burden and risks
On an individual level, patients who participate are asked to complete
questionnaires at five consecutive points in time, spread over a timeframe of
two years. It takes a patient about 30 minutes to complete each questionnaire.
No burden is expected here. The collection of blood at three occasions (which
takes about 10 minutes per occasion) is considered minimally invasive.
Optionally, patients can also choose to wear a Fitbit Inspire (activity
tracker) at 5 points in time, participate in the *BijKankerApp* (at baseline
and during active treatment) and/or fill out a food diary at 2 points in time.
These activities are considered minimally invasive too. Furthermore, patients
can contact an independent doctor for more information about this study.
Zernikestraat 29
Eindhoven 5612HZ
NL
Zernikestraat 29
Eindhoven 5612HZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Patients diagnosed with either HL, NHL, CLL or MM
- 18 years or older
- Able to fill out questionnaires Dutch (in terms of language skills and
cognitive abilities).
Exclusion criteria
Patients with severe psychopathology or dementia, and patients in transition to
terminal care will be excluded from the study. We will only have our
questionnaire in Dutch, so patients who cannot read Dutch will be unable to
complete the questionnaire.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78561.015.21 |