<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/NCT03254875</url>
  </required_header>
  <id_info>
    <org_study_id>REBECCA II</org_study_id>
    <nct_id>NCT03254875</nct_id>
  </id_info>
  <brief_title>Rehabilitation After Breast Cancer</brief_title>
  <acronym>REBECCA II</acronym>
  <official_title>Individually Tailored Rehabilitation After Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen University Hospital at Herlev</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Danish Cancer Society</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 of the study is to evaluate whether a screening-based individually tailored nurse&#xD;
      navigator intervention compared to standard care significantly reduce psychological and&#xD;
      physical symptoms among women being treated for breast cancer who had moderate-to-severe&#xD;
      distress (score ≥ 7 on the distress thermometer).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for&#xD;
      inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324&#xD;
      participants enter the randomized controlled trial (RCT) and are randomized in a&#xD;
      computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group&#xD;
      (standard care). A total of 432 participants will enter an observational questionnaire study.&#xD;
      All participants are followed for 1,5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the RCT and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Intervention status will be blinded in analyses.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Distress</measure>
    <time_frame>Change from baseline and to 6,12 months (mixed models)</time_frame>
    <description>Distress Thermometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distress</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>Distress Thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress</measure>
    <time_frame>Change from baseline to 12 months</time_frame>
    <description>Distress Thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress</measure>
    <time_frame>Change from baseline to 18 months</time_frame>
    <description>Distress Thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>The Patient Health Questionnaire (PHQ9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>Generalized Anxiety Disorder (GAD7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Generalized Anxiety Disorder (GAD7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Generalized Anxiety Disorder (GAD7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Generalized Anxiety Disorder (GAD7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life summary index</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:&#xD;
Physical well-being (PWB)&#xD;
Functional wellbeing (FWB)&#xD;
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life summary index</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:&#xD;
Physical well-being (PWB)&#xD;
Functional wellbeing (FWB)&#xD;
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life summary index</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:&#xD;
Physical well-being (PWB)&#xD;
Functional wellbeing (FWB)&#xD;
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life summary index</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:&#xD;
Physical well-being (PWB)&#xD;
Functional wellbeing (FWB)&#xD;
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast cancer related quality of life summary index</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast cancer related quality of life summary index</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast cancer related quality of life summary index</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast cancer related quality of life summary index</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional related quality of life summary index</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional related quality of life summary index</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional related quality of life summary index</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional related quality of life summary index</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical health related quality of life</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical health related quality of life</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical health related quality of life</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical health related quality of life</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social health related quality of life</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social health related quality of life</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social health related quality of life</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social health related quality of life</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional health related quality of life</measure>
    <time_frame>Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)</time_frame>
    <description>Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional health related quality of life</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional health related quality of life</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional health related quality of life</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Patient Activation Measure (PAM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Patient Activation Measure (PAM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Patient Activation Measure (PAM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Patient Activation Measure (PAM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of recurrence</measure>
    <time_frame>6 months</time_frame>
    <description>Concerns About Recurrence Questionnaire (CARQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of recurrence</measure>
    <time_frame>12 months</time_frame>
    <description>Concerns About Recurrence Questionnaire (CARQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of recurrence</measure>
    <time_frame>18 months</time_frame>
    <description>Concerns About Recurrence Questionnaire (CARQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropathy in the breast surgery area (side of chest, armpit or arm)</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Self-developed scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Perceived cognitive impairments</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Perceived cognitive impairments</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function- Perceived cognitive impairments</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Perceived cognitive impairments</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Impact of Perceived cognitive impairments on quality of life</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Impact of Perceived cognitive impairments on quality of life</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Impact of Perceived cognitive impairments on quality of life</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Impact of Perceived cognitive impairments on quality of life</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Perceived cognitive abilities</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Perceived cognitive abilities</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Perceived cognitive abilities</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function - Perceived cognitive abilities</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for support</measure>
    <time_frame>Change from baseline and to 6,12,18 months (mixed models)</time_frame>
    <description>Single self-developed items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for support</measure>
    <time_frame>Change from baseline and to 6 months</time_frame>
    <description>Single self-developed items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for support</measure>
    <time_frame>Change from baseline and to 12 months</time_frame>
    <description>Single self-developed items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for support</measure>
    <time_frame>Change from baseline and to 18 months</time_frame>
    <description>Single self-developed items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care costs</measure>
    <time_frame>Cumulative from baseline to 18 months</time_frame>
    <description>Costs will be obtained through registries on health care services and combined with information on health status using the 5Q-5D from the EuroQol Research Foundation's</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>18 months</time_frame>
    <description>Single self-developed items</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Social support</measure>
    <time_frame>Baseline</time_frame>
    <description>Modified Medical Outcomes Study Social Support Scale (MOS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">309</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individually tailored nurse navigation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individually tailored nurse navigation</intervention_name>
    <description>The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast&#xD;
             cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above,&#xD;
             Danish citizen, read, understand and speak Danish, female gender,signed written&#xD;
             informed consent. Those who experience high psychological distress (score ≥ 7 on the&#xD;
             distress thermometer) will enter the RCT whereas those who experience low&#xD;
             psychological distress (score &lt; 7 on the distress thermometer) will be followed in an&#xD;
             observational questionnaire study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no severe cognitive problems or dementia, no severe psychiatric disease requiring&#xD;
             treatment, e.g. schizophrenia, alcohol or narcotic dependence,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pernille Bidstrup, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Cancer Society Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christoffer Johansen, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshispitalet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Birgitte Mertz, RN</last_name>
    <role>Study Chair</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 26, 2021</last_update_submitted>
  <last_update_submitted_qc>August 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danish Cancer Society</investigator_affiliation>
    <investigator_full_name>Christoffer Johansen</investigator_full_name>
    <investigator_title>Professor, DMSc</investigator_title>
  </responsible_party>
  <keyword>Breast cancer, Psychosocial 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/NCT03254875
org study id: REBECCA II
nct id: NCT03254875
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate whether a screening-based individually tailored nurse
      navigator intervention compared to standard care significantly reduce psychological and
      physical symptoms among women being treated for breast cancer who had moderate-to-severe
      distress (score ≥ 7 on the distress thermometer).
During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for
      inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324
      participants enter the randomized controlled trial (RCT) and are randomized in a
      computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group
      (standard care). A total of 432 participants will enter an observational questionnaire study.
      All participants are followed for 1,5 years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the RCT and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Intervention status will be blinded in analyses.
measure: Distress
time frame: Change from baseline and to 6,12 months (mixed models)
description: Distress Thermometer
measure: Distress
time frame: Change from baseline to 6 months
description: Distress Thermometer
measure: Distress
time frame: Change from baseline to 12 months
description: Distress Thermometer
measure: Distress
time frame: Change from baseline to 18 months
description: Distress Thermometer
measure: Depression
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: The Patient Health Questionnaire (PHQ9)
measure: Depression
time frame: Change from baseline and to 6 months
description: The Patient Health Questionnaire (PHQ9)
measure: Depression
time frame: Change from baseline and to 12 months
description: The Patient Health Questionnaire (PHQ9)
measure: Depression
time frame: Change from baseline and to 18 months
description: The Patient Health Questionnaire (PHQ9)
measure: Anxiety
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: Generalized Anxiety Disorder (GAD7)
measure: Anxiety
time frame: Change from baseline and to 6 months
description: Generalized Anxiety Disorder (GAD7)
measure: Anxiety
time frame: Change from baseline and to 12 months
description: Generalized Anxiety Disorder (GAD7)
measure: Anxiety
time frame: Change from baseline and to 18 months
description: Generalized Anxiety Disorder (GAD7)
measure: Health related quality of life summary index
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
Physical well-being (PWB)
Functional wellbeing (FWB)
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Health related quality of life summary index
time frame: Change from baseline and to 6 months
description: The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
Physical well-being (PWB)
Functional wellbeing (FWB)
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Health related quality of life summary index
time frame: Change from baseline and to 12 months
description: The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
Physical well-being (PWB)
Functional wellbeing (FWB)
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Health related quality of life summary index
time frame: Change from baseline and to 18 months
description: The Trial Outcome Index-Physical/Functional/Breast (TOI-PFB) score including Domains:
Physical well-being (PWB)
Functional wellbeing (FWB)
BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Breast cancer related quality of life summary index
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Breast cancer related quality of life summary index
time frame: Change from baseline and to 6 months
description: BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Breast cancer related quality of life summary index
time frame: Change from baseline and to 12 months
description: BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Breast cancer related quality of life summary index
time frame: Change from baseline and to 18 months
description: BC symptoms (BCS) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Functional related quality of life summary index
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Functional related quality of life summary index
time frame: Change from baseline and to 6 months
description: Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Functional related quality of life summary index
time frame: Change from baseline and to 12 months
description: Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Functional related quality of life summary index
time frame: Change from baseline and to 18 months
description: Functional wellbeing (FWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Physical health related quality of life
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Physical health related quality of life
time frame: Change from baseline and to 6 months
description: Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Physical health related quality of life
time frame: Change from baseline and to 12 months
description: Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Physical health related quality of life
time frame: Change from baseline and to 18 months
description: Physical well-being (PWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Social health related quality of life
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Social health related quality of life
time frame: Change from baseline and to 6 months
description: Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Social health related quality of life
time frame: Change from baseline and to 12 months
description: Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Social health related quality of life
time frame: Change from baseline and to 18 months
description: Social/Family well-being (SWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Emotional health related quality of life
time frame: Change from baseline and to 3, 10, 18 weeks, 6,12,18 months (mixed models)
description: Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Emotional health related quality of life
time frame: Change from baseline and to 6 months
description: Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Emotional health related quality of life
time frame: Change from baseline and to 12 months
description: Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Emotional health related quality of life
time frame: Change from baseline and to 18 months
description: Emotional well-being (EWB) from the Functional Assessment of Chronic Illness Therapy - Breast (FACT-B)
measure: Self-efficacy
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Patient Activation Measure (PAM)
measure: Self-efficacy
time frame: Change from baseline and to 6 months
description: Patient Activation Measure (PAM)
measure: Self-efficacy
time frame: Change from baseline and to 12 months
description: Patient Activation Measure (PAM)
measure: Self-efficacy
time frame: Change from baseline and to 18 months
description: Patient Activation Measure (PAM)
measure: Fear of recurrence
time frame: 6 months
description: Concerns About Recurrence Questionnaire (CARQ)
measure: Fear of recurrence
time frame: 12 months
description: Concerns About Recurrence Questionnaire (CARQ)
measure: Fear of recurrence
time frame: 18 months
description: Concerns About Recurrence Questionnaire (CARQ)
measure: Pain in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Self-developed scale
measure: Pain in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 6 months
description: Self-developed scale
measure: Pain in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 12 months
description: Self-developed scale
measure: Pain in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 18 months
description: Self-developed scale
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Self-developed scale
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 6 months
description: Self-developed scale
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 12 months
description: Self-developed scale
measure: Neuropathy in the breast surgery area (side of chest, armpit or arm)
time frame: Change from baseline and to 18 months
description: Self-developed scale
measure: Sleep quality
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Pittsburgh Sleep Quality Index (PSQI)
measure: Sleep quality
time frame: Change from baseline and to 6 months
description: Pittsburgh Sleep Quality Index (PSQI)
measure: Sleep quality
time frame: Change from baseline and to 12 months
description: Pittsburgh Sleep Quality Index (PSQI)
measure: Sleep quality
time frame: Change from baseline and to 18 months
description: Pittsburgh Sleep Quality Index (PSQI)
measure: Cognitive function - Perceived cognitive impairments
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
measure: Cognitive function - Perceived cognitive impairments
time frame: Change from baseline and to 6 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
measure: Cognitive function- Perceived cognitive impairments
time frame: Change from baseline and to 12 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
measure: Cognitive function - Perceived cognitive impairments
time frame: Change from baseline and to 18 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale Perceived cognitive impairments
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
time frame: Change from baseline and to 6 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
time frame: Change from baseline and to 12 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
measure: Cognitive function - Impact of Perceived cognitive impairments on quality of life
time frame: Change from baseline and to 18 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Impact of Perceived cognitive impairments on quality of life
measure: Cognitive function - Perceived cognitive abilities
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
measure: Cognitive function - Perceived cognitive abilities
time frame: Change from baseline and to 6 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
measure: Cognitive function - Perceived cognitive abilities
time frame: Change from baseline and to 12 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
measure: Cognitive function - Perceived cognitive abilities
time frame: Change from baseline and to 18 months
description: Functional Assessment of Chronic Illness Therapy - Cognitive function (FACT-cog) - Sub-scale - Perceived cognitive abilities
measure: Need for support
time frame: Change from baseline and to 6,12,18 months (mixed models)
description: Single self-developed items
measure: Need for support
time frame: Change from baseline and to 6 months
description: Single self-developed items
measure: Need for support
time frame: Change from baseline and to 12 months
description: Single self-developed items
measure: Need for support
time frame: Change from baseline and to 18 months
description: Single self-developed items
measure: Health care costs
time frame: Cumulative from baseline to 18 months
description: Costs will be obtained through registries on health care services and combined with information on health status using the 5Q-5D from the EuroQol Research Foundation's
measure: Acceptability
time frame: 18 months
description: Single self-developed items
measure: Social support
time frame: Baseline
description: Modified Medical Outcomes Study Social Support Scale (MOS)
arm group label: Intervention
arm group type: Experimental
description: Individually tailored nurse navigation
arm group label: Control
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: Individually tailored nurse navigation
description: The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pernille Bidstrup, PhD
role: Principal Investigator
affiliation: Danish Cancer Society Research Center
last name: Christoffer Johansen, DMSc
role: Principal Investigator
affiliation: Rigshispitalet
last name: Birgitte Mertz, RN
role: Study Chair
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Danish Cancer Society
investigator full name: Christoffer Johansen
investigator title: Professor, DMSc
mesh term: Breast Neoplasms
sharing ipd: No