Patients diagnosed with a glioblastoma and their family caregivers are mainly impaired by
the poor prognosis and the high symptom burden. Caregivers report impaired health-related
quality of life (HRQOL) and high distress. They even may experience significantly higher
levels of anxiety and depression than patients themselves . Furthermore, Boele et al.
showed that the overall survival in glioblastoma patients is associated with family
caregivers' mastery.
In newly diagnosed glioblastoma, the EF-14 RCT demonstrated significantly prolonged
survival in patients treated with TTFields compared to controls, with a median overall
survival (OS) of 20.9 vs.#46;16.0 months.
Several studies showed an important association of the daily compliance rate with OS and
progression-free survival (PFS). Family caregivers' support might be associated to the
patients' compliance and adequate support is required. However, so far rare supportive
programs for patients and their caregivers have been established. It has been shown that
delivery of supportive care via telehealth is feasible, however studies examining the
effectiveness, adoption and maintenance of telehealth interventions in glioblastoma
patients and family caregivers are still lacking. The aim is to improve patients'
compliance to TTFields therapy by a psychological video intervention.
It is a multi-center, randomized controlled trial.
Main inclusion criteria are:
- - Diagnosis of a GBM/being a GBM patient's caregiver.
- - Patients eligible for radiochemotherapy with TMZ and 60Gy.
- - Tumorboard recommendation for TTFields therapy.
- - Access to a computer and internet.
- - Absence of medical reasons precluding participation in a supportive intervention.
The experimental intervention is:
Delivery of supportive care via telehealth intervention (including a brief psychological
intervention and information/educational support regarding the disease, therapy and
self-help options) in family caregivers and patients.The intervention encompasses six interventions (video call) for patients and caregivers.
The six sessions will be conducted by the psychologists of the coordinating center to
allow homogeneous and sound implementation of the BPI. All psychologists are certified
psychooncologists.
The first part of the sessions is scheduled immediately after start of radiochemotherapy
(+ 2 weeks) in order to guide patients and caregivers in this important phase after first
diagnose.
- - First session/week 1 (+ 2 weeks) after start of radiochemotherapy: Engage and
motivate patients and caregivers to participate and to develop open communication
(60-90min), followed by a follow up phone call a few days later.
- - Second session/week 2 (+ 2 weeks) after start of radiochemotherapy: Review of the
last session and follow-up phone.
Education on the techniques for optimistic
attitude (including positive self-talk, positive thinking, and speaking positive).
Discussion about necessity of setting achievable short-term goals in treatment
process. Homework: "Write at least 3 achievable short-term goals" (45 min), followed
by a follow up phone call a few days later.
The second part of the sessions is scheduled after completion of radiochemotherapy phase
(+ 2 weeks) with focus in the adjuvant temozolomide therapy and TTFields therapy.
- - Third session/week 7 (+ 2 weeks) after completed radiochemotherapy: Review of the
last session, discussion over the phone, and homework.
Providing information or
advice about treatment, the TTFields therapy and medication.
- - Responding to hopelessness (focusing on positive details of the clinical
course, the progress which patients made since surgery, but also sharing fears,
and negative thoughts).
Sharing community resources (websites, hospitals, and
counseling centers).
- - Importance of TTFields therapy and association of daily compliance rate with
prognosis, FAQ list, recommendations and practical aspects.
- - Homework: "Provide a list of supportive resources in your community" "Provide a
list of questions to the health care professionals" (45-60min), followed by a
follow up phone call a few days later.
- - Fourth session/week 8 (+ 2 weeks) after completed radiochemotherapy:
- Education on the techniques for stress management (including physical activity,
social contact/relationship, spending time in activity and nature (60-90
minutes) and healthy lifestyle behaviors.
- - Questions regarding TTFields and chemotherapy.
- - Homework: "List the useful strategies to manage your stress during the
treatment process of your partner", "Apply stress management techniques".
(45-60min), followed by a follow up phone call a few days later.
- - Fifth session/week 9 (+ 2 weeks) after completed radiochemotherapy:
- First assessment after start of TTFields therapy, evaluation of practical
questions and well-being.
- - Education of self-care strategies (including eating well-balanced meals,
permission to feel bad-schedule it in your day, permission to feel good, put
off major life decisions (if it is possible), take breaks from periods of
isolation, exercise - even a little bit, and let yourself cry (45-60 min).
- - Sixth session/week 10 (+ 2 weeks) after completed radiochemotherapy: Feedback
regarding the sessions before and planning of implementation of the learned
strategies for the upcoming months.
Homework: "List the strategies personally useful
and what personally motivates you, learned in the last weeks"
The control condition is: Standard of care with standard access to psychosocial support
in certified Neuro-Oncological Centers.Primary Outcome:
Compliance to TTFields compared in intervention and control group.Secondary Outcomes:
- - Patients' health-related quality of Life (HRQoL), symptom burden, self-efficacy,
anxiety, depression and its association to the intervention.
- - Patient- and family caregiver-reported acceptance of intervention, patients´
acceptance of TTFields.
- - Adverse event of special interest: Skin irritation.
- - Patients' and family caregivers emotional and physical well-being,
- Correlation between endpoints to investigate dependencies of underlying concepts.
- - Analysis of health utilization measures.
Optional Outcomes:
On a voluntary basis the following biosamples will be acquired for assessment of stress
level and immunogenic response.
- blood