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

Primary Purpose

Compliance, Patient, Glioblastoma, Astrocytoma, Grade IV

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychological intervention
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Compliance, Patient focused on measuring psychosocial support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention arm

    Control arm

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Safety of TTFields
    Adverse event of special interest: Skin irritation in patients under TTFields therapy
    Incidence of burdened caregivers
    Caregiver emotional and physical well-being, patient emotional and physical well-being

    Full Information

    First Posted
    July 12, 2023
    Last Updated
    August 23, 2023
    Sponsor
    University Hospital Tuebingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06017063
    Brief Title
    Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields
    Acronym
    COCOON
    Official Title
    Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    April 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital Tuebingen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 20.9 vs 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 hair probes blood

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Compliance, Patient, Glioblastoma, Astrocytoma, Grade IV
    Keywords
    psychosocial support

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    275 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention arm
    Arm Type
    Experimental
    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.
    Arm Title
    Control arm
    Arm Type
    No Intervention
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Psychological intervention
    Intervention Description
    The intervention will include a psychological intervention with counseling sessions (online/video intervention) and telephone follow-up additionally to the care as usual.
    Primary Outcome Measure Information:
    Title
    EFFICACY of intervention
    Description
    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 Outcome Measure Information:
    Title
    TOLERABILITY of psychooncological intervention
    Description
    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)
    Title
    Safety of TTFields
    Description
    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)
    Title
    Incidence of burdened caregivers
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mirjam Renovanz, MD
    Phone
    0049 7071 29 61903
    Email
    mirjam.renovanz@med.uni-tuebingen.de

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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