<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/NCT04480203</url>
  </required_header>
  <id_info>
    <org_study_id>CABC - Kreftfor project - SEB</org_study_id>
    <nct_id>NCT04480203</nct_id>
  </id_info>
  <brief_title>Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions</brief_title>
  <acronym>CABC</acronym>
  <official_title>Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Registry of Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Registry of Norway</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>
      1. Breast cancer patients and age-matched controls are first invited to answer questions on&#xD;
           HRQoL.&#xD;
&#xD;
        2. Among responding breast cancer patients, a subset are invited in a randomized clinical&#xD;
           trial with two digital interventions for cancer stress management, cognitive based&#xD;
           stress management (CBSM) and mindfulness based intervention (MBI), as well as a control&#xD;
           group.&#xD;
&#xD;
        3. The goal is to determine whether digital CBSM or MBI can effectively reduce stress&#xD;
           levels as compared to a control group. Second, whether these interventions can improve&#xD;
           HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a&#xD;
           control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After completing the baseline HRQoL assessment, eligible breast cancer patients will be&#xD;
      invited to participate in a randomized clinical trial.&#xD;
&#xD;
      Those who are willing will be randomly allocated to one of the following arms: a) Digital&#xD;
      cognitive based stress management, b) Digital mindfulness based intervention or c) Control&#xD;
      group.&#xD;
&#xD;
      The intervention is based on a revised version of the Stressproffen app, which was developed&#xD;
      by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).&#xD;
&#xD;
      Outcome measures include measures of perceived stress and HRQoL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 15, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2035</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>An intervention study of breast cancer patients with two digital intervention arms and one control group.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stress</measure>
    <time_frame>change from CABC baseline (week 0) to f-up week 21</time_frame>
    <description>Cohens perceived stress scale. Unit is summary score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective health (HRQoL)</measure>
    <time_frame>change from CABC baseline (week 0) to f-up week 21</time_frame>
    <description>RAND-36 questionnaire. Unit is summary score and module-specific scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping</measure>
    <time_frame>change from CABC baseline (week 0) to f-up week 21</time_frame>
    <description>TOMCATS questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>change from CABC baseline (week 0) to f-up week 21</time_frame>
    <description>PHQ-4 questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>change from CABC baseline (week 0) to f-up week 21</time_frame>
    <description>Chalders' fatigue questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>change from CABC baseline (week 0) to f-up week 21</time_frame>
    <description>Baer 2006 mindfulness questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>change from CABC baseline (week 0) to f-up week 21</time_frame>
    <description>selected questions fro SUSSH questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30</measure>
    <time_frame>From NBCR baseline to f-up week 20</time_frame>
    <description>EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23</measure>
    <time_frame>From NBCR baseline to f-up week 20</time_frame>
    <description>EORTC breast cancer questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy (FACT GOG-NTX and -ES)</measure>
    <time_frame>From NBCR baseline to f-up week 20</time_frame>
    <description>neuropathy questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 15</time_frame>
    <description>Cohens perceived stress scale. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective health (HRQoL)</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 15</time_frame>
    <description>RAND-36 questionnaire. Unit is summary score and module-specific scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 15</time_frame>
    <description>TOMCATS questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 15</time_frame>
    <description>Chalders' fatigue questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 15</time_frame>
    <description>Baer 2006 mindfulness questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 15</time_frame>
    <description>PHQ-4 questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 15</time_frame>
    <description>selected questions fro SUSSH questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work</measure>
    <time_frame>status at f-up month 15</time_frame>
    <description>questions on employment. Whether employed and percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 27</time_frame>
    <description>Cohens perceived stress scale. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective health (HRQoL)</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 27</time_frame>
    <description>RAND-36 questionnaire. Unit is summary score and module-specific scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 27</time_frame>
    <description>TOMCATS questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 27</time_frame>
    <description>PHQ-4 questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 27</time_frame>
    <description>Chalders' fatigue questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 27</time_frame>
    <description>Baer 2006 mindfulness questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>change from CABC baseline (week 0) to f-up month 27</time_frame>
    <description>selected questions fro SUSSH questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30</measure>
    <time_frame>change from NBCR baseline to f-up month 27</time_frame>
    <description>EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-BR23</measure>
    <time_frame>change from NBCR baseline to f-up month 27</time_frame>
    <description>EORTC breast cancer questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy (FACT GOG-NTX and -ES)</measure>
    <time_frame>From NBCR baseline to f-up month 27</time_frame>
    <description>neuropathy questionnaire. Unit is summary score.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">390</enrollment>
  <condition>Breast Cancer Patients</condition>
  <condition>Health, Subjective</condition>
  <arm_group>
    <arm_group_label>Cognitive based stress management (CBSM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive based digital intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness based intervention (MBI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mindfulness based digital intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control arm. No intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stressproffen cognitive based stress management</intervention_name>
    <description>The participants will download an app (Stressproffen 2A) with cognitive based stress management.</description>
    <arm_group_label>Cognitive based stress management (CBSM)</arm_group_label>
    <other_name>CBSM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stressproffen mindfulness based intervention</intervention_name>
    <description>The participants will download an app (Stressproffen 2B) with mindfulness based intervention.</description>
    <arm_group_label>Mindfulness based intervention (MBI)</arm_group_label>
    <other_name>MBI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The participants will receive no app. (They will be able to download it after the end of the 3 year study).</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first occurrence breast cancer diagnosed from Jan 1, 2020&#xD;
&#xD;
          -  non-metastatic cancer stage 0-III&#xD;
&#xD;
        Invasive tumors must be:&#xD;
&#xD;
          -  HER2 positive (regardless of ER, PR) or&#xD;
&#xD;
          -  ER negative&#xD;
&#xD;
          -  (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female breast cancer patients</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giske Ursin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Registry of Norway</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Giske Ursin, MD, PhD</last_name>
    <phone>+4722451300</phone>
    <email>giske.ursin@kreftregisteret.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ine M Larsson</last_name>
    <phone>+4722928985</phone>
    <email>ine.marie.larsson@kreftregisteret.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Registry of Norway</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giske Ursin</last_name>
      <phone>+47 22928701</phone>
      <email>giske.ursin@kreftregisteret.no</email>
    </contact>
    <contact_backup>
      <last_name>Ine Marie Larsson</last_name>
      <phone>+4722928985</phone>
      <email>ine.marie.larsson@kreftregisteret.no</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 11, 2022</last_update_submitted>
  <last_update_submitted_qc>February 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health Related Quality of Life</keyword>
  <keyword>Stress management intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04480203
org study id: CABC - Kreftfor project - SEB
nct id: NCT04480203
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. Breast cancer patients and age-matched controls are first invited to answer questions on
           HRQoL.

        2. Among responding breast cancer patients, a subset are invited in a randomized clinical
           trial with two digital interventions for cancer stress management, cognitive based
           stress management (CBSM) and mindfulness based intervention (MBI), as well as a control
           group.

        3. The goal is to determine whether digital CBSM or MBI can effectively reduce stress
           levels as compared to a control group. Second, whether these interventions can improve
           HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a
           control group.
After completing the baseline HRQoL assessment, eligible breast cancer patients will be
      invited to participate in a randomized clinical trial.

      Those who are willing will be randomly allocated to one of the following arms: a) Digital
      cognitive based stress management, b) Digital mindfulness based intervention or c) Control
      group.

      The intervention is based on a revised version of the Stressproffen app, which was developed
      by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).

      Outcome measures include measures of perceived stress and HRQoL.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: An intervention study of breast cancer patients with two digital intervention arms and one control group.
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.
measure: Stress
time frame: change from CABC baseline (week 0) to f-up week 21
description: Cohens perceived stress scale. Unit is summary score.
measure: Subjective health (HRQoL)
time frame: change from CABC baseline (week 0) to f-up week 21
description: RAND-36 questionnaire. Unit is summary score and module-specific scores
measure: Coping
time frame: change from CABC baseline (week 0) to f-up week 21
description: TOMCATS questionnaire. Unit is summary score.
measure: Anxiety and depression
time frame: change from CABC baseline (week 0) to f-up week 21
description: PHQ-4 questionnaire. Unit is summary score.
measure: Fatigue
time frame: change from CABC baseline (week 0) to f-up week 21
description: Chalders' fatigue questionnaire. Unit is summary score.
measure: Mindfulness
time frame: change from CABC baseline (week 0) to f-up week 21
description: Baer 2006 mindfulness questionnaire. Unit is summary score.
measure: Sleep
time frame: change from CABC baseline (week 0) to f-up week 21
description: selected questions fro SUSSH questionnaire. Unit is summary score.
measure: EORTC QLQ-C30
time frame: From NBCR baseline to f-up week 20
description: EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
measure: EORTC QLQ-BR23
time frame: From NBCR baseline to f-up week 20
description: EORTC breast cancer questionnaire. Unit is summary score.
measure: Neuropathy (FACT GOG-NTX and -ES)
time frame: From NBCR baseline to f-up week 20
description: neuropathy questionnaire. Unit is summary score.
measure: Stress
time frame: change from CABC baseline (week 0) to f-up month 15
description: Cohens perceived stress scale. Unit is summary score.
measure: Subjective health (HRQoL)
time frame: change from CABC baseline (week 0) to f-up month 15
description: RAND-36 questionnaire. Unit is summary score and module-specific scores
measure: Coping
time frame: change from CABC baseline (week 0) to f-up month 15
description: TOMCATS questionnaire. Unit is summary score.
measure: Fatigue
time frame: change from CABC baseline (week 0) to f-up month 15
description: Chalders' fatigue questionnaire. Unit is summary score.
measure: Mindfulness
time frame: change from CABC baseline (week 0) to f-up month 15
description: Baer 2006 mindfulness questionnaire. Unit is summary score.
measure: Anxiety and depression
time frame: change from CABC baseline (week 0) to f-up month 15
description: PHQ-4 questionnaire. Unit is summary score.
measure: Sleep
time frame: change from CABC baseline (week 0) to f-up month 15
description: selected questions fro SUSSH questionnaire. Unit is summary score.
measure: Work
time frame: status at f-up month 15
description: questions on employment. Whether employed and percentage
measure: Stress
time frame: change from CABC baseline (week 0) to f-up month 27
description: Cohens perceived stress scale. Unit is summary score.
measure: Subjective health (HRQoL)
time frame: change from CABC baseline (week 0) to f-up month 27
description: RAND-36 questionnaire. Unit is summary score and module-specific scores
measure: Coping
time frame: change from CABC baseline (week 0) to f-up month 27
description: TOMCATS questionnaire. Unit is summary score.
measure: Anxiety and depression
time frame: change from CABC baseline (week 0) to f-up month 27
description: PHQ-4 questionnaire. Unit is summary score.
measure: Fatigue
time frame: change from CABC baseline (week 0) to f-up month 27
description: Chalders' fatigue questionnaire. Unit is summary score.
measure: Mindfulness
time frame: change from CABC baseline (week 0) to f-up month 27
description: Baer 2006 mindfulness questionnaire. Unit is summary score.
measure: Sleep
time frame: change from CABC baseline (week 0) to f-up month 27
description: selected questions fro SUSSH questionnaire. Unit is summary score.
measure: EORTC QLQ-C30
time frame: change from NBCR baseline to f-up month 27
description: EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
measure: EORTC QLQ-BR23
time frame: change from NBCR baseline to f-up month 27
description: EORTC breast cancer questionnaire. Unit is summary score.
measure: Neuropathy (FACT GOG-NTX and -ES)
time frame: From NBCR baseline to f-up month 27
description: neuropathy questionnaire. Unit is summary score.
arm group label: Cognitive based stress management (CBSM)
arm group type: Active Comparator
description: Cognitive based digital intervention.
arm group label: Mindfulness based intervention (MBI)
arm group type: Active Comparator
description: Mindfulness based digital intervention.
arm group label: Control
arm group type: Placebo Comparator
description: Control arm. No intervention.
intervention type: Other
intervention name: Stressproffen cognitive based stress management
description: The participants will download an app (Stressproffen 2A) with cognitive based stress management.
arm group label: Cognitive based stress management (CBSM)
other name: CBSM
intervention type: Other
intervention name: Stressproffen mindfulness based intervention
description: The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
arm group label: Mindfulness based intervention (MBI)
other name: MBI
intervention type: Other
intervention name: Control
description: The participants will receive no app. (They will be able to download it after the end of the 3 year study).
arm group label: Control
criteria: 
gender: Female
gender based: Yes
gender description: Female breast cancer patients
minimum age: 20 Years
maximum age: 69 Years
healthy volunteers: No
last name: Giske Ursin, MD, PhD
role: Principal Investigator
affiliation: Cancer Registry of Norway
last name: Giske Ursin, MD, PhD
phone: +4722451300
email: giske.ursin@kreftregisteret.no
last name: Ine M Larsson
phone: +4722928985
email: ine.marie.larsson@kreftregisteret.no
facility: 
status: Recruiting
contact: 
contact backup: 
country: Norway
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No