<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/NCT02200731</url>
  </required_header>
  <id_info>
    <org_study_id>FAMOS</org_study_id>
    <nct_id>NCT02200731</nct_id>
  </id_info>
  <brief_title>FAMily Oriented Support (FAMOS): Psychosocial Intervention for Childhood Cancer Survivors and Their Families</brief_title>
  <official_title>FAMOS: The Effect of Psychosocial Intervention for Childhood Cancer Survivors and Their Families: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pernille Bidstrup</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Danish Cancer Society</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether a home-based psychosocial family intervention that takes place shortly&#xD;
      after ending the primary medical treatment can help families adjust to their cancer-related&#xD;
      psychological issues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this randomized controlled trial is to investigate whether home-based&#xD;
      psychosocial interventions are able to help families of childhood cancer survivors cope with&#xD;
      cancer-related psychological issues.&#xD;
&#xD;
      Method: 300 families will be recruited from the four pediatric oncology departments in&#xD;
      Denmark where 150 families' will receive a home-based psychosocial intervention and 150&#xD;
      families will be in the control group. The study will take place shortly after the child&#xD;
      completes the primary treatment. The primary outcome is post-traumatic stress symptoms (PTSS)&#xD;
      in parents and secondary outcomes include among others quality of life, sick-leave, coping&#xD;
      strategies and family functioning. Families in the intervention group will receive a 6&#xD;
      session manualized intervention based on a Cognitive Behavioral framework. Four sessions will&#xD;
      focus on the parents and two sessions will focus on the child, who had cancer, and his/her&#xD;
      siblings. The main goal of the sessions is to teach families how to adapt healthy&#xD;
      psychological adjustments to pediatric oncology and prevent PTSS in family members. As a part&#xD;
      of the intervention, families will be presented with video clips of other parents discussing&#xD;
      how cancer has affected their family, to show common issues in experiencing having a child&#xD;
      undergo cancer treatment. Every family member will be asked to complete a set of&#xD;
      questionnaires to measure the outcome of the intervention at baseline before the&#xD;
      intervention, 6 months follow-up and 12 months follow-up.&#xD;
&#xD;
      It is expected that families in the intervention group experience a larger improvement in&#xD;
      their post-traumatic stress symptoms as well as strengthening the family function, quality of&#xD;
      life and reducing sick leave compared to the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">June 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 6 months follow up compared to parents in the control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 12 months follow up versus parents in the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post traumatic stress symptoms (PTSS) in childhood cancer survivors and their siblings measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>A larger reduction in PTSS from baseline to respectively 6 and 12 months follow up in childhood cancer survivors and their siblings the intervention group versus the control group measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family psychosocial functioning measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0)</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>An larger enhancement in the family's' psychosocial functioning from baseline to 6 months follow up and 12 months follow up measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0) in the intervention group versus the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Siblings perception measured by the Siblings Perception Questionnaire (SPQ)</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>A change in siblings' perception of how cancer affected their daily life from baseline to 6 months and 12 months follow-up measured by Sibling Perception Questionnaire (SPQ) in the intervention group versus the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by Pediatric Quality of Life (PedsQL)</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>An enhancement in quality of life in childhood cancer survivors, their siblings and parents from baseline to 6 month and 12 month follow-up measured by Pediatric Quality of Life (PedsQL) in the intervention group versus the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self reported sick leave in parents</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>A larger reduction in sick leave for parents from baseline to 6 month and 12 month follow-up measured by self reporting in the intervention group versus the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Less stress induced telomere shortening</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>A 10 ml blood sample to measure whether a psychosocial intervention results in a less shortening of the telomere length amongst parents of childhood cancer survivors from baseline to 12 months follow up versus parents in the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression in parents of childhood cancer survivors measured by the Symptom Checklist (SCL)</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>A larger reduction in anxiety and depression symptoms in parents of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression in siblings over 18 years of childhood cancer survivors measured by the Symptom Checklist (SCL)</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>A larger reduction in anxiety and depression symptoms in siblings over 18 years of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression in childhood cancer survivors and their siblings i the age range 8 to 17 years measured by the Revised Child Anxiety and Depression Scale (RCADS)</measure>
    <time_frame>Baseline, 6 months and 12 months</time_frame>
    <description>A larger reduction in anxiety and depression symptoms in childhood cancer survivors and their siblings i the age range 8 to 17 years in the intervention group from baseline to 6 and 12 months follow up compared to the control group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>Childhood Cancer</condition>
  <arm_group>
    <arm_group_label>FAMOS: psychosocial family intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In Denmark, standard care after treatment does not include systematic psychosocial support. Families are able to seek support on their own or contact a support group offered by the Danish Cancer Society. However support specializing the families with childhood cancer survivors and their siblings after ending medial treatment is limited.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FAMOS: psychosocial family intervention</intervention_name>
    <description>The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience</description>
    <arm_group_label>FAMOS: psychosocial family intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Families of children in the age range of 0-17 years diagnosed with any kind of cancer&#xD;
             and treated at one of the four pediatric oncology departments in Denmark are invited&#xD;
             to participate in the project after ending primary medical treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the child has a severe co-morbidity&#xD;
&#xD;
          -  If the child has a mental disorder at diagnosis&#xD;
&#xD;
          -  If the child is declared terminal ill at the end of treatment (less than 6 months of&#xD;
             survival).&#xD;
&#xD;
          -  If the parents and the children do not speak Danish. The participants have to be able&#xD;
             to read and answer the questionnaires at the least, to be included in the project.&#xD;
&#xD;
          -  If the parents do not wish to hand in consent form&#xD;
&#xD;
          -  If the family participates in another randomized psychosocial intervention project&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoffer Johansen, Phd, Dr. MEd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Cancer Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanin Salem, Phd student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Cancer Society</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danish Cancer Society</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>February 4, 2021</last_update_submitted>
  <last_update_submitted_qc>February 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Danish Cancer Society</investigator_affiliation>
    <investigator_full_name>Pernille Bidstrup</investigator_full_name>
    <investigator_title>PhD, group leader</investigator_title>
  </responsible_party>
  <keyword>Childhood cancer</keyword>
  <keyword>Psychosocial intervention</keyword>
  <keyword>Family</keyword>
  <keyword>Siblings</keyword>
  <keyword>Childhood cancer survivors</keyword>
  <keyword>Cogntive Behavioural</keyword>
  <keyword>Manualized</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02200731
org study id: FAMOS
nct id: NCT02200731
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
To investigate whether a home-based psychosocial family intervention that takes place shortly
      after ending the primary medical treatment can help families adjust to their cancer-related
      psychological issues.
The objective of this randomized controlled trial is to investigate whether home-based
      psychosocial interventions are able to help families of childhood cancer survivors cope with
      cancer-related psychological issues.

      Method: 300 families will be recruited from the four pediatric oncology departments in
      Denmark where 150 families' will receive a home-based psychosocial intervention and 150
      families will be in the control group. The study will take place shortly after the child
      completes the primary treatment. The primary outcome is post-traumatic stress symptoms (PTSS)
      in parents and secondary outcomes include among others quality of life, sick-leave, coping
      strategies and family functioning. Families in the intervention group will receive a 6
      session manualized intervention based on a Cognitive Behavioral framework. Four sessions will
      focus on the parents and two sessions will focus on the child, who had cancer, and his/her
      siblings. The main goal of the sessions is to teach families how to adapt healthy
      psychological adjustments to pediatric oncology and prevent PTSS in family members. As a part
      of the intervention, families will be presented with video clips of other parents discussing
      how cancer has affected their family, to show common issues in experiencing having a child
      undergo cancer treatment. Every family member will be asked to complete a set of
      questionnaires to measure the outcome of the intervention at baseline before the
      intervention, 6 months follow-up and 12 months follow-up.

      It is expected that families in the intervention group experience a larger improvement in
      their post-traumatic stress symptoms as well as strengthening the family function, quality of
      life and reducing sick leave compared to the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
time frame: Baseline and 6 months
description: A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 6 months follow up compared to parents in the control group
measure: Post traumatic stress symptoms (PTSS) in parents measured by Harvard Trauma Questionnaire (HTQ)
time frame: Baseline and 12 months
description: A larger reduction in post traumatic stress symptoms amongst parents of childhood cancer survivors in the intervention group from baseline to 12 months follow up versus parents in the control group
measure: Post traumatic stress symptoms (PTSS) in childhood cancer survivors and their siblings measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)
time frame: Baseline, 6 months and 12 months
description: A larger reduction in PTSS from baseline to respectively 6 and 12 months follow up in childhood cancer survivors and their siblings the intervention group versus the control group measured by Harvard Trauma Questionnaire (HTQ), Daryl or Pediatric Emotional Distress Scale (PEDS)
measure: Family psychosocial functioning measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0)
time frame: Baseline, 6 months and 12 months
description: An larger enhancement in the family's' psychosocial functioning from baseline to 6 months follow up and 12 months follow up measured by Psychological Assessment Tool 2.0 (PAT2.0) and Family Impact Module 2.0 (FIM2.0) in the intervention group versus the control group.
measure: Siblings perception measured by the Siblings Perception Questionnaire (SPQ)
time frame: Baseline, 6 months and 12 months
description: A change in siblings' perception of how cancer affected their daily life from baseline to 6 months and 12 months follow-up measured by Sibling Perception Questionnaire (SPQ) in the intervention group versus the control group.
measure: Quality of life measured by Pediatric Quality of Life (PedsQL)
time frame: Baseline, 6 months and 12 months
description: An enhancement in quality of life in childhood cancer survivors, their siblings and parents from baseline to 6 month and 12 month follow-up measured by Pediatric Quality of Life (PedsQL) in the intervention group versus the control group
measure: Self reported sick leave in parents
time frame: Baseline, 6 months and 12 months
description: A larger reduction in sick leave for parents from baseline to 6 month and 12 month follow-up measured by self reporting in the intervention group versus the control group.
measure: Less stress induced telomere shortening
time frame: Baseline and 12 months
description: A 10 ml blood sample to measure whether a psychosocial intervention results in a less shortening of the telomere length amongst parents of childhood cancer survivors from baseline to 12 months follow up versus parents in the control group
measure: Anxiety and depression in parents of childhood cancer survivors measured by the Symptom Checklist (SCL)
time frame: Baseline, 6 months and 12 months
description: A larger reduction in anxiety and depression symptoms in parents of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group
measure: Anxiety and depression in siblings over 18 years of childhood cancer survivors measured by the Symptom Checklist (SCL)
time frame: Baseline, 6 months and 12 months
description: A larger reduction in anxiety and depression symptoms in siblings over 18 years of childhood cancer survivors in the intervention group from baseline to 6 and 12 months follow up compared to the control group
measure: Anxiety and depression in childhood cancer survivors and their siblings i the age range 8 to 17 years measured by the Revised Child Anxiety and Depression Scale (RCADS)
time frame: Baseline, 6 months and 12 months
description: A larger reduction in anxiety and depression symptoms in childhood cancer survivors and their siblings i the age range 8 to 17 years in the intervention group from baseline to 6 and 12 months follow up compared to the control group
arm group label: FAMOS: psychosocial family intervention
arm group type: Experimental
description: The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience.
arm group label: Control
arm group type: No Intervention
description: In Denmark, standard care after treatment does not include systematic psychosocial support. Families are able to seek support on their own or contact a support group offered by the Danish Cancer Society. However support specializing the families with childhood cancer survivors and their siblings after ending medial treatment is limited.
intervention type: Behavioral
intervention name: FAMOS: psychosocial family intervention
description: The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience
arm group label: FAMOS: psychosocial family intervention
criteria: 
gender: All
minimum age: N/A
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christoffer Johansen, Phd, Dr. MEd
role: Principal Investigator
affiliation: Danish Cancer Society
last name: Hanin Salem, Phd student
role: Principal Investigator
affiliation: Danish Cancer Society
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Danish Cancer Society
investigator full name: Pernille Bidstrup
investigator title: PhD, group leader
sharing ipd: Undecided