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

NCT06017063 | Not Yet Recruiting

• 1 other identifier: 345/2023BO1
• Study Type: interventional
• Target: 275
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Compliance, Patient; Glioblastoma; Astrocytoma, Grade IV

Keywords

psychosocial support

Outcome Measures

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

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

Secondary Outcomes (3)

• TOLERABILITY of psychooncological intervention

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

• Safety of TTFields

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

• Incidence of burdened caregivers

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

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Other: Psychological intervention

Control arm

NO INTERVENTION

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.

Interventions

Psychological intervention OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Conditions

Patient Compliance; Glioblastoma

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mirjam Renovanz, MD

CONTACT

0049 7071 29 61903; mirjam.renovanz@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 30, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 30, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL