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Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields

ConditionsCompliance, PatientGlioblastomaAstrocytoma, Grade IV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Tuebingen

About this trial

The aim is to improve patients' compliance to TTFields therapy by a psychological video intervention in a multi-center, randomized controlled trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ability to understand and give an informed consent, capacity to consent

Given informed consent

≥ 18 years of age

Patients with newly diagnosed glioblastoma

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychological intervention

    Other intervention

    The intervention will include a psychological intervention with counseling sessions (online/video intervention) and telephone follow-up additionally to the care as usual.

Treatment groups

275 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

EFFICACY of intervention

Compliance to TTFields compared in intervention and control group.Compliance will be measured by the duration of the TTFields application in each patient

Time frame
9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)

Secondary outcomes

1

TOLERABILITY of psychooncological intervention

Patient- and caregiver-reported acceptance of intervention as measured by number of patient and cargiver dyads who completed the 6th session of the psychooncological intervention

Time frame
9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)
2

Safety of TTFields

Adverse event of special interest: Skin irritation in patients under TTFields therapy

Time frame
9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)
3

Incidence of burdened caregivers

Caregiver emotional and physical well-being, patient emotional and physical well-being

Time frame
9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Tuebingen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: