brain tumor glioma
Conditions
Interventions
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
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
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: Suicidal intent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed