Clinical trial · Interventional
Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields
NCT06017063CI-TRIAL-00069191COCOONnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim is to improve patients' compliance to TTFields therapy by a psychological video intervention in a multi-center, randomized controlled trial.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, Grade IV | Astrocytoma | CURATED_BROADER | 0.80 |
| Compliance, Patient | — | UNRESOLVED | — |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychological intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Patients and caregivers will participate in support program encompassing six video interventions with the BPI. Both participate in the intervention at the same time and together. The intervention starts within two weeks after start of the radiochemotherapy phase, see also figure 2. Patients and caregivers will receive an invitation link to the Vidyo sessions and can log in together to participate in the sessions.
- interventionNames
- Other: Psychological intervention
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Patients and caregivers randomized to the control group, they will not receive the 6-week intervention by the psycho-oncologist. However, they are still entitled to guideline-based psycho-oncology counseling according to the guideline and local standard if they wish. Subsequently, they will be supported regarding coping with the disease, how to improve their mood, or which strategies are available in dealing with the disease. This conversation will last 30-60 minutes.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and give an informed consent, capacity to consent * Given informed consent * ≥ 18 years of age * Patients with newly diagnosed glioblastoma * Patients with IDH-mutant Astrocytoma, CNS WHO-Grade 4, newly diagnosed (by biopsy or incomplete tumor resection) * Patients eligible for radiochemotherapy with temozolomide and 60 Gy * Patients before radiochemotherapy phase or within the first 2 weeks * Prescription of TTFields according clinical routine (including but not exclusive to) * Access to a computer and internet * Absence of medical reasons precluding participation in a supportive intervention Exclusion Criteria: * Ability to understand and give an informed consent, capacity to consent * Given informed consent * ≥ 18 years of age * Being a family caregiver of a patient with newly diagnosed glioblastoma * Access to a computer and internet * Absence of medical reasons precluding participation in a supportive intervention
References
Publications (0)
Data not yet available
No reference posted for this study.