Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017063
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-07-12
Brief Title:
Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COCOON
Brief Summary:
The aim is to improve patients compliance to TTFields therapy by a psychological video intervention in a multi-center randomized controlled trial
Detailed Description:
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 209 vs 160 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 GBMbeing a GBM patients 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 informationeducational 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 sessionweek 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 sessionweek 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 sessionweek 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 sessionweek 8 2 weeks after completed radiochemotherapy
Education on the techniques for stress management including physical activity social contactrelationship 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 sessionweek 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 sessionweek 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
hair probes
blood
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 209 vs 160 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 GBMbeing a GBM patients 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 informationeducational 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 sessionweek 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 sessionweek 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 sessionweek 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 sessionweek 8 2 weeks after completed radiochemotherapy
Education on the techniques for stress management including physical activity social contactrelationship 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 sessionweek 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 sessionweek 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
hair probes
blood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None