We aim to gain insight into the incidence and severity of CIPN and its influence on patient-reported outcomes (i.e. health related quality of life (HRQoL), disease-specific complaints, depression, fatigue, sleep problems) among a prospective…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neuropathy, health-related quality of life, disease-specific complaints,
depression, fatigue, sleep problems, personality, comorbidity, physical
activity, health care utilisation, health supplement use, employment, genetic
and biological markers including pro-and anti-inflammatory cytokines (IL-1β,
IL-6, TNF-α, IL-RN, and IL-10) genes.
Secondary outcome
not applicable
Background summary
Due to the increasing prevalence of cancer, more patients are living with the
side-effects of cancer and its treatment. Especially the development of
chemotherapy-induced peripheral neuropathy (CIPN) is a major concern. CIPN is a
condition featuring pain, numbness, tingling, and sensitivity to cold in the
hands and feet which sometimes progresses to the arms and legs. Its prevalence
is expected to increase since the indications for chemotherapy are broadened
and new chemotherapeutic agents with CIPN side-effects are in use. Although the
number of patients at risk for CIPN is likely to increase, its influence on
patient-reported outcomes, health care utilisation, physical activity, and
employment are often unknown as is the role of personality on CIPN experience.
Study objective
We aim to gain insight into the incidence and severity of CIPN and its
influence on patient-reported outcomes (i.e. health related quality of life
(HRQoL), disease-specific complaints, depression, fatigue, sleep problems)
among a prospective population-based sample of colorectal cancer (CRC)
patients. Furthermore, we will study the role of personality on CIPN experience
and we will investigate the influence of CIPN on health care utilisation,
physical activity, and employment. Finally, we will investigate the role of
genetic/biological markers of inflammation on neuropathy, HRQOL and pain.
Study design
We plan to perform a prospective population-based study in which we include CRC
patients before the start of treatment and follow them until 2 years after
treatment. Patients from the hospitals in the Eindhoven Cancer Registry area
will be asked to fill out questionnaires on CIPN, HRQoL, depression, fatigue,
sleep problems, personality, health care utilisation, physical activity, health
supplements use, and employment at 4 points in time (before surgery, within a
month after surgery (e.g. before chemotherapy), within a month after
chemotherapy (e.g. one year after diagnosis), and 2 years after diagnosis. In
Máxima Medisch Centrum, we will ask patients who underwent a curative surgery
to fill in a short questionnaire on HRQoL at an extra point in time (i.e., 3
months after surgery). Clinical data like disease stage, cumulative dose of
chemotherapy and dose reductions will be extracted from patients* medical
records and the Eindhoven Cancer Registry. Also, patients will be asked to
donate a blood sample 3 times (2X10 ml, 10 minutes) in order to examine the
association between HRQOL, pain, genetic and biological markers of
inflammation. The blood draws will take place at the hospital.
Study burden and risks
In three of the four hospitals, patients will be asked to fill in a
questionnaire (+/-40 minutes a questionnaire) at 4 points in time. In Máxima
Medisch Centrum, patients who underwent a curative surgery will be asked to
fill in a short questionnaire (+/-10 minutes) at an extra point in time (i.e.,
three months after surgery). Also, patients from all four hospitals will be
asked to donate blood on three occasions. The blood draws will take place at
the hospitals.
Zernikestraat 29
EINDHOVEN 5612 HZ
NL
Zernikestraat 29
EINDHOVEN 5612 HZ
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with colorectal cancer
- 18 years or older
Exclusion criteria
- Patients with cognitive impairment will not be included because of expected difficulties in completing these questionnaires without assistance.
- Patients who are not able to read or write Dutch will be excluded, as they are not able to
complete a Dutch 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 | NL51119.060.14 |