xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017063</url>
    </required_header>
    <id_info>
      <org_study_id>345/2023BO1</org_study_id>
      <nct_id>NCT06017063</nct_id>
    </id_info>
    <brief_title>Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields</brief_title>
    <acronym>COCOON</acronym>
    <official_title>Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Tuebingen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital Tuebingen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim is to improve patients' compliance to TTFields therapy by a psychological video&#xD;
        intervention in a multi-center, randomized controlled trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients diagnosed with a glioblastoma and their family caregivers are mainly impaired by the&#xD;
        poor prognosis and the high symptom burden. Caregivers report impaired health-related quality&#xD;
        of life (HRQOL) and high distress. They even may experience significantly higher levels of&#xD;
        anxiety and depression than patients themselves . Furthermore, Boele et al. showed that the&#xD;
        overall survival in glioblastoma patients is associated with family caregivers' mastery.&#xD;
  &#xD;
        In newly diagnosed glioblastoma, the EF-14 RCT demonstrated significantly prolonged survival&#xD;
        in patients treated with TTFields compared to controls, with a median overall survival (OS)&#xD;
        of 20.9 vs 16.0 months.&#xD;
  &#xD;
        Several studies showed an important association of the daily compliance rate with OS and&#xD;
        progression-free survival (PFS). Family caregivers' support might be associated to the&#xD;
        patients' compliance and adequate support is required. However, so far rare supportive&#xD;
        programs for patients and their caregivers have been established. It has been shown that&#xD;
        delivery of supportive care via telehealth is feasible, however studies examining the&#xD;
        effectiveness, adoption and maintenance of telehealth interventions in glioblastoma patients&#xD;
        and family caregivers are still lacking. The aim is to improve patients' compliance to&#xD;
        TTFields therapy by a psychological video intervention.&#xD;
  &#xD;
        It is a multi-center, randomized controlled trial.&#xD;
  &#xD;
        Main inclusion criteria are:&#xD;
  &#xD;
          -  Diagnosis of a GBM/being a GBM patient's caregiver&#xD;
  &#xD;
          -  Patients eligible for radiochemotherapy with TMZ and 60Gy&#xD;
  &#xD;
          -  Tumorboard recommendation for TTFields therapy&#xD;
  &#xD;
          -  Access to a computer and internet&#xD;
  &#xD;
          -  Absence of medical reasons precluding participation in a supportive intervention&#xD;
  &#xD;
        The experimental intervention is:&#xD;
  &#xD;
        Delivery of supportive care via telehealth intervention (including a brief psychological&#xD;
        intervention and information/educational support regarding the disease, therapy and self-help&#xD;
        options) in family caregivers and patients&#xD;
  &#xD;
        The intervention encompasses six interventions (video call) for patients and caregivers.&#xD;
  &#xD;
        The six sessions will be conducted by the psychologists of the coordinating center to allow&#xD;
        homogeneous and sound implementation of the BPI. All psychologists are certified&#xD;
        psychooncologists.&#xD;
  &#xD;
        The first part of the sessions is scheduled immediately after start of radiochemotherapy (+ 2&#xD;
        weeks) in order to guide patients and caregivers in this important phase after first&#xD;
        diagnose.&#xD;
  &#xD;
          -  First session/week 1 (+ 2 weeks) after start of radiochemotherapy: Engage and motivate&#xD;
             patients and caregivers to participate and to develop open communication (60-90min),&#xD;
             followed by a follow up phone call a few days later.&#xD;
  &#xD;
          -  Second session/week 2 (+ 2 weeks) after start of radiochemotherapy: Review of the last&#xD;
             session and follow-up phone. Education on the techniques for optimistic attitude&#xD;
             (including positive self-talk, positive thinking, and speaking positive). Discussion&#xD;
             about necessity of setting achievable short-term goals in treatment process. Homework:&#xD;
             &quot;Write at least 3 achievable short-term goals&quot; (45 min), followed by a follow up phone&#xD;
             call a few days later.&#xD;
  &#xD;
        The second part of the sessions is scheduled after completion of radiochemotherapy phase (+ 2&#xD;
        weeks) with focus in the adjuvant temozolomide therapy and TTFields therapy.&#xD;
  &#xD;
          -  Third session/week 7 (+ 2 weeks) after completed radiochemotherapy: Review of the last&#xD;
             session, discussion over the phone, and homework. Providing information or advice about&#xD;
             treatment, the TTFields therapy and medication.&#xD;
  &#xD;
               -  Responding to hopelessness (focusing on positive details of the clinical course,&#xD;
                  the progress which patients made since surgery, but also sharing fears, and&#xD;
                  negative thoughts). Sharing community resources (websites, hospitals, and&#xD;
                  counseling centers).&#xD;
  &#xD;
               -  Importance of TTFields therapy and association of daily compliance rate with&#xD;
                  prognosis, FAQ list, recommendations and practical aspects&#xD;
  &#xD;
               -  Homework: &quot;Provide a list of supportive resources in your community&quot; &quot;Provide a&#xD;
                  list of questions to the health care professionals&quot; (45-60min), followed by a&#xD;
                  follow up phone call a few days later.&#xD;
  &#xD;
          -  Fourth session/week 8 (+ 2 weeks) after completed radiochemotherapy:&#xD;
  &#xD;
               -  Education on the techniques for stress management (including physical activity,&#xD;
                  social contact/relationship, spending time in activity and nature (60-90 minutes)&#xD;
                  and healthy lifestyle behaviors.&#xD;
  &#xD;
               -  Questions regarding TTFields and chemotherapy&#xD;
  &#xD;
               -  Homework: &quot;List the useful strategies to manage your stress during the treatment&#xD;
                  process of your partner&quot;, &quot;Apply stress management techniques&quot;. (45-60min),&#xD;
                  followed by a follow up phone call a few days later.&#xD;
  &#xD;
          -  Fifth session/week 9 (+ 2 weeks) after completed radiochemotherapy:&#xD;
  &#xD;
               -  First assessment after start of TTFields therapy, evaluation of practical questions&#xD;
                  and well-being&#xD;
  &#xD;
               -  Education of self-care strategies (including eating well-balanced meals, permission&#xD;
                  to feel bad-schedule it in your day, permission to feel good, put off major life&#xD;
                  decisions (if it is possible), take breaks from periods of isolation, exercise -&#xD;
                  even a little bit, and let yourself cry (45-60 min).&#xD;
  &#xD;
          -  Sixth session/week 10 (+ 2 weeks) after completed radiochemotherapy: Feedback regarding&#xD;
             the sessions before and planning of implementation of the learned strategies for the&#xD;
             upcoming months. Homework: &quot;List the strategies personally useful and what personally&#xD;
             motivates you, learned in the last weeks&quot;&#xD;
  &#xD;
        The control condition is: Standard of care with standard access to psychosocial support in&#xD;
        certified Neuro-Oncological Centers&#xD;
  &#xD;
        Primary Outcome:&#xD;
  &#xD;
        Compliance to TTFields compared in intervention and control group&#xD;
  &#xD;
        Secondary Outcomes:&#xD;
  &#xD;
          -  Patients' health-related quality of Life (HRQoL), symptom burden, self-efficacy,&#xD;
             anxiety, depression and its association to the intervention.&#xD;
  &#xD;
          -  Patient- and family caregiver-reported acceptance of intervention, patients´ acceptance&#xD;
             of TTFields&#xD;
  &#xD;
          -  Adverse event of special interest: Skin irritation&#xD;
  &#xD;
          -  Patients' and family caregivers emotional and physical well-being,&#xD;
  &#xD;
          -  Correlation between endpoints to investigate dependencies of underlying concepts.&#xD;
  &#xD;
          -  Analysis of health utilization measures.&#xD;
  &#xD;
        Optional Outcomes:&#xD;
  &#xD;
        On a voluntary basis the following biosamples will be acquired for assessment of stress level&#xD;
        and immunogenic response&#xD;
  &#xD;
          -  hair probes&#xD;
  &#xD;
          -  blood&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">April 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>randomized controlled trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>EFFICACY of intervention</measure>
      <time_frame>9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)</time_frame>
      <description>Compliance to TTFields compared in intervention and control group.Compliance will be measured by the duration of the TTFields application in each patient</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>TOLERABILITY of psychooncological intervention</measure>
      <time_frame>9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of TTFields</measure>
      <time_frame>9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)</time_frame>
      <description>Adverse event of special interest: Skin irritation in patients under TTFields therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of burdened caregivers</measure>
      <time_frame>9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)</time_frame>
      <description>Caregiver emotional and physical well-being, patient emotional and physical well-being</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">275</enrollment>
    <condition>Compliance, Patient</condition>
    <condition>Glioblastoma</condition>
    <condition>Astrocytoma, Grade IV</condition>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Psychological intervention</intervention_name>
      <description>The intervention will include a psychological intervention with counseling sessions (online/video intervention) and telephone follow-up additionally to the care as usual.</description>
      <arm_group_label>Intervention arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to understand and give an informed consent, capacity to consent&#xD;
  &#xD;
            -  Given informed consent&#xD;
  &#xD;
            -  ≥ 18 years of age&#xD;
  &#xD;
            -  Patients with newly diagnosed glioblastoma&#xD;
  &#xD;
            -  Patients with IDH-mutant Astrocytoma, CNS WHO-Grade 4, newly diagnosed (by biopsy or&#xD;
               incomplete tumor resection)&#xD;
  &#xD;
            -  Patients eligible for radiochemotherapy with temozolomide and 60 Gy&#xD;
  &#xD;
            -  Patients before radiochemotherapy phase or within the first 2 weeks&#xD;
  &#xD;
            -  Prescription of TTFields according clinical routine (including but not exclusive to)&#xD;
  &#xD;
            -  Access to a computer and internet&#xD;
  &#xD;
            -  Absence of medical reasons precluding participation in a supportive intervention&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ability to understand and give an informed consent, capacity to consent&#xD;
  &#xD;
            -  Given informed consent&#xD;
  &#xD;
            -  ≥ 18 years of age&#xD;
  &#xD;
            -  Being a family caregiver of a patient with newly diagnosed glioblastoma&#xD;
  &#xD;
            -  Access to a computer and internet&#xD;
  &#xD;
            -  Absence of medical reasons precluding participation in a supportive intervention&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mirjam Renovanz, MD</last_name>
      <phone>0049 7071 29 61903</phone>
      <email>mirjam.renovanz@med.uni-tuebingen.de</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>psychosocial support</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioblastoma</mesh_term>
      <mesh_term>Astrocytoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017063
  org study id: 345/2023BO1
  nct id: NCT06017063
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim is to improve patients' compliance to TTFields therapy by a psychological video
        intervention in a multi-center, randomized controlled trial.
  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
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized controlled trial
  primary purpose: Other
  masking: None (Open Label)
  measure: EFFICACY of intervention
  time frame: 9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)
  description: Compliance to TTFields compared in intervention and control group.Compliance will be measured by the duration of the TTFields application in each patient
  measure: TOLERABILITY of psychooncological intervention
  time frame: 9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)
  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
  measure: Safety of TTFields
  time frame: 9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)
  description: Adverse event of special interest: Skin irritation in patients under TTFields therapy
  measure: Incidence of burdened caregivers
  time frame: 9 months, last visit after completed 6 cycle of adjuvant Temozolomide (each cycle is 28 days)
  description: Caregiver emotional and physical well-being, patient emotional and physical well-being
  arm group label: Intervention arm
  arm group type: Experimental
  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 group label: Control arm
  arm group type: No Intervention
  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: Psychological 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.
  arm group label: Intervention arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mirjam Renovanz, MD
  phone: 0049 7071 29 61903
  email: mirjam.renovanz@med.uni-tuebingen.de
  responsible party type: Sponsor
  mesh term: Glioblastoma
  mesh term: Astrocytoma
  sharing ipd: Yes
  ipd info type: Study Protocol