The primary study objectives are: (1) to determine whether an internet-based guided self-help intervention is effective in reducing symptoms of depression in glioma patients; (2) to determine the impact of the intervention on the HRQOL of both…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's unspecified histology
- Nervous system neoplasms malignant and unspecified NEC
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measures are taken at 0 weeks (pre-test) and after conclusion of the
intervention at 5 weeks (post-test), at 3 months follow-up and at 6 and 12
months follow-up for high-grade glioma patients and at 12 months follow-up for
low-grade glioma patients. The primary outcome measure is the change in
depressive symptoms as measured by the Center for Epidemiological Studies
Depression Scale (CES-D). This is a valid and reliable self-report
questionnaire used to measure depressive feelings during the past week. The
questionnaire consists of 20 propositions, where the respondent indicates how
often this proposition applies to him/her (rarely or never, sometimes,
regularly, most of the time or always). The sum score lies between 0 and 60. A
higher score indicates more feelings of depression. In the general population,
people with a score higher than 16 are considered depressed.
Secondary outcome
Secondary outcome measures are quality of life (SF-36, EuroQol, BCM20),
symptoms of fatigue (CIS-20), cognitive functioning (a 6-item scale that was
developed during the Medical Outcomes Study) and variables that may predict
outcome, such as client satisfaction and problem-solving skills. Although a
true economic analysis will not be conducted, we will collect data on the costs
of the intervention (internet application, costs of the coaches) per patient,
and both in money and hours of working time.
Clinical data to be recorded at study entry will include tumor characteristics
(histology, size, site), and treatment history (biopsy, surgery, chemotherapy,
corticosteroids, anti-epileptic medication). Additionally, data on potential
tumor progression/recurrence and treatment of recurrent tumor (radiotherapy,
chemotherapy, corticosteroids) will be collected. AII clinical data will be
derived from the medical records and provided by the treating physician or the
family physician. Questions on depressive symptoms, quality of life, fatigue,
patient satisfaction, problem-solving skills, and data on the costs of the
intervention will be presented online in a fixed order. Patients will be
allowed to return to any of the measures for review or changes.
Background summary
Depression is a major health problem in glioma patients, with emotional,
cognitive, and physical sequelae. Depression in these patients may be
associated with increased morbidity and even with poorer survival. In addition,
depression is the most important independent predictor of health-related
quality of life (HRQOL) in patients with brain tumors affecting not only
patients but also their informal caregivers (i.e., partner, good friend, or
family member). The etiology of depression may be due to tumor location,
treatment, or patient response to the diagnosis. Treatment of depression
usually includes a combination of psychotherapy, group therapy, and
medications. Glioma patients, however, are not inclined to seek help for mental
health problems. The internet is a medium which is used much easier by glioma
patients to seek help for mental health problems. This project is aimed at the
development of an internet-based intervention for glioma patients with mild to
moderate depression. This type of intervention has been proven to be effective
in adult non-cancer populations with mild to moderate depression, but not in
glioma patients.
Study objective
The primary study objectives are:
(1) to determine whether an internet-based guided self-help intervention is
effective in reducing symptoms of depression in glioma patients;
(2) to determine the impact of the intervention on the HRQOL of both glioma
patients and their informal caregivers (partner, good friend, or family
member);
(3) to evaluate the compliance and feasibility of the intervention in this
patient population; and
(4) to evaluate the cost-effectiveness of the intervention.
Study design
A web-based intervention that has been proven effective (Allesondercontrole)
will be adapted for use by glioma patients.
Fifty low-grade glioma patients will be included in the intervention group and
50 low-grade glioma patients will be included in the waiting list control
group. After a three-month period, these patients can also take part in the
intervention. Furthermore, 50 patients with hematological malignancies whose
disease does not include the central nervous system will form a control group.
They will take part in the internet-intervention. Outcome is evaluated before
and after the intervention, at 3 and at 12 months follow-up.
Fifty high-grade glioma patients will be included in the intervention group and
50 high-grade glioma patients will be included in the waiting list control
group. After a three-month period, these patients can also take part in the
intervention. Furthermore, 50 patients with non-small cell lung cancer without
metastasis in the central nervous system will form a control group. They will
take part in the internet-intervention. Outcome is evaluated before and after
the intervention, at 3, at 6 and at 12 months follow-up.
Intervention
As web-based intervention we use the website *Allesondercontrole* (Everything
under control), an intervention for brief problem-solving which is based on
self-examination therapy. This intervention is already available (only for
research purposes, not for the general public) and has been tested in adults
with depressive symptoms, anxiety symptoms, and/or stress related symptoms. The
website Allesondercontrole (www.ggzelfhulp.nl/index.php?fId=752) can be used in
this target population with small adaptations. In a randomized controlled trial
with 215 adults, this intervention was found to have significant effects on
depression, anxiety and stress/burnout. This is also confirmed in international
studies in which was found that this intervention (as guided self-help) is
effective in reducing depression and anxiety symptoms.
The intervention takes five weeks. During that period, patients describe what
they think is important in their lives, make a list of their problems and
concerns, and divide these into three categories: unimportant problems
(problems which are not related to what is important in their life), important
and solvable (these are solved through a six-step procedure of
problem-solving), and important but unsolvable (such as loosing someone through
death; for each of these problems the patient makes a plan how to cope with
this). We think that this intervention is very well suited for glioma patients.
First, the intervention is relatively simple and does not require complex
skills or understanding of intrapersonal processes (such as changing
cognitions). Second, this intervention is exactly about the things glioma
patients are thinking about during this phase of their life (what is important
for me and how do I solve existing problems). The participants get feedback on
the homework assignments every week from a personal coach. The coach is not a
therapist, but only supports the patient in working through the intervention.
The coaching is given by specialists from Prezens.
After three months, the participants in the control groups who only received
information about depression will be offered the same intervention.
Study burden and risks
During the intervention the participants are to spend about 3 hours a week on
homework assignments. This means a total of 15 hours for the entire
intervention. Additionally, 4 extra hours will be reserved for filling in the
questionnaires during the pre- and postmeasures.
The risks of participation in this study are negligible. The control group of
glioma patients who do not receive the intervention immediately might be made
more aware of their depressive symptoms because of the questionnaires they are
asked to fill in. However, we keep track of their CES-D scores. This way we can
monitor whether or not the depressive symptoms have gotten worse, in which case
we will contact their physician.
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Experimental groups:;1: adult (>18 years of age) WHO Grade II low-grade glioma survivors.
Mild to moderate depressive symptoms (CES-D score >=12). Participants have to have access to internet and an email account. ;2: adult (>18 years of age) WHO Grade III and Grade IV high-grade glioma patients with an estimated life expectancy of >3 months. Mild to moderate depressive symptoms (CES-D score >=12). Participants have to have access to internet and an email account. ;Control groups:;1: adult (>18 years of age) WHO Grade II low-grade glioma survivors. Mild to moderate depressive symptoms (CES-D score >=12). Participants have to have access to internet and an email account. ;2: adult (>18 years of age) WHO Grade III and Grade IV high-grade glioma patients with an estimated life expectancy of >3 months. Mild to moderate depressive symptoms (CES-D score >=12). Participants have to have access to internet and an email account. ;3. adult (>18 years of age) patients with hematological malignancies without involvement of the central nervous system. Mild to moderate depressive symptoms (CES-D score >=12). Participants have to have access to internet and an email account. ;4. adult (>18 years of age) patients with non-small cell lung cancer without clinical signs of central nervous system involvement. Mild to moderate depressive symptoms (CES-D score >=12). Participants have to have access to internet and an email account.
Exclusion criteria
Suicidal intent
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 | NL36095.029.11 |