<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/NCT02982746</url>
  </required_header>
  <id_info>
    <org_study_id>University of Gothenburgh</org_study_id>
    <nct_id>NCT02982746</nct_id>
  </id_info>
  <brief_title>Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Göteborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At all of the follow-ups, including the worst period (between four and ten weeks), the&#xD;
      intervention group reported higher scores than the control group, suggesting in this RCT that&#xD;
      adopting the person-centred-care concept was a promising way to improve function and&#xD;
      wellbeing in patients with HNC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The incidence of head and neck cancer (HNC) is increasing slightly. HNC and its&#xD;
      treatment may affect general domains of health-related quality of life (HRQoL) and provoke a&#xD;
      variety of adverse symptoms and side effects, both during and after treatment. The objective&#xD;
      of this study was to compare a person-centred care intervention in terms of HRQoL,&#xD;
      disease-specific symptoms or problems, with traditional care as a control group for patients&#xD;
      with HNC. Methods: The intervention and control groups comprised 54 and 42 patients,&#xD;
      respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both&#xD;
      groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of&#xD;
      treatment. The questionnaires' scores were compared between groups by using independent&#xD;
      samples test (Student's t-test) and non-parametric test (Mann-Whitney U Test) for continuous&#xD;
      variables. For categorical data, Fisher's exact test was used. Longitudinal data were&#xD;
      analysed using repeated measures in covariance pattern models. Results: At baseline, the&#xD;
      intervention and control groups were comparable in terms of medical and sociodemographic&#xD;
      variables, clinical characteristics, HRQoL and disease-specific symptoms or problems. At all&#xD;
      the follow-up points, even during the worst period for the patients, the person-centred-care&#xD;
      group consistently reported higher scores than the control group. The differences were&#xD;
      numerically but not always statistically significant. When using repeated measures in&#xD;
      covariance pattern models, statistically significant results were found for HNC-specific&#xD;
      problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Health related quality of life EORTC QLQ-30 EORTC QLQ-35</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life EORTC QLQ-30 EORTC QLQ-35</measure>
    <time_frame>Four weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life EORTC QLQ-30 EORTC QLQ-35</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life EORTC QLQ-30 EORTC QLQ-35</measure>
    <time_frame>18 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life EORTC QLQ-30 EORTC QLQ-35</measure>
    <time_frame>52 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Health Related Quality of Life</condition>
  <arm_group>
    <arm_group_label>gPCC-G (Gothenburg Person Centred Care) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gPCC-G Patients randomized to the intervention group were contacted and scheduled to attend a meeting at the oncology clinic with the nurse specialist in oncology</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group Patients randomized to the control group received usual care and return visits were scheduled according to the treatment procedure described under the previous heading and based on the Regional care program for patients with HNC. CG patients were recruited at the same time and in the same way as those in the intervention group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>gPCC (Gothenburg Person Centred Care)</intervention_name>
    <arm_group_label>gPCC-G (Gothenburg Person Centred Care) Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for this study were patients diagnosed with HNC, older than 18 years and able&#xD;
             to read and write Swedish and, in addition, suitable for outpatient treatment with&#xD;
             chemo- and/or radiotherapy, either as primary treatment or in a postoperative setting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if they had a previous or concomitant malignancy or were&#xD;
             diagnosed and treated for depression as stated in their medical record.&#xD;
&#xD;
          -  In order to minimize the risk of bias, none of the patients were to be included if&#xD;
             they were taking part in other research studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Head and neck cancer</keyword>
  <keyword>Person Centred Care</keyword>
  <keyword>Health related quality of life</keyword>
  <keyword>EORTC QLQ-C30</keyword>
  <keyword>EORTC QLQ-C35</keyword>
  <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/NCT02982746
org study id: University of Gothenburgh
nct id: NCT02982746
lead sponsor: 
has dmc: No
At all of the follow-ups, including the worst period (between four and ten weeks), the
      intervention group reported higher scores than the control group, suggesting in this RCT that
      adopting the person-centred-care concept was a promising way to improve function and
      wellbeing in patients with HNC.
Background: The incidence of head and neck cancer (HNC) is increasing slightly. HNC and its
      treatment may affect general domains of health-related quality of life (HRQoL) and provoke a
      variety of adverse symptoms and side effects, both during and after treatment. The objective
      of this study was to compare a person-centred care intervention in terms of HRQoL,
      disease-specific symptoms or problems, with traditional care as a control group for patients
      with HNC. Methods: The intervention and control groups comprised 54 and 42 patients,
      respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both
      groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of
      treatment. The questionnaires' scores were compared between groups by using independent
      samples test (Student's t-test) and non-parametric test (Mann-Whitney U Test) for continuous
      variables. For categorical data, Fisher's exact test was used. Longitudinal data were
      analysed using repeated measures in covariance pattern models. Results: At baseline, the
      intervention and control groups were comparable in terms of medical and sociodemographic
      variables, clinical characteristics, HRQoL and disease-specific symptoms or problems. At all
      the follow-up points, even during the worst period for the patients, the person-centred-care
      group consistently reported higher scores than the control group. The differences were
      numerically but not always statistically significant. When using repeated measures in
      covariance pattern models, statistically significant results were found for HNC-specific
      problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
time frame: Baseline
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
time frame: Four weeks
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
time frame: 10 weeks
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
time frame: 18 weeks
measure: Health related quality of life EORTC QLQ-30 EORTC QLQ-35
time frame: 52 weeks
arm group label: gPCC-G (Gothenburg Person Centred Care) Group
arm group type: Experimental
description: gPCC-G Patients randomized to the intervention group were contacted and scheduled to attend a meeting at the oncology clinic with the nurse specialist in oncology
arm group label: Control group
arm group type: No Intervention
description: Control Group Patients randomized to the control group received usual care and return visits were scheduled according to the treatment procedure described under the previous heading and based on the Regional care program for patients with HNC. CG patients were recruited at the same time and in the same way as those in the intervention group
intervention type: Other
intervention name: gPCC (Gothenburg Person Centred Care)
arm group label: gPCC-G (Gothenburg Person Centred Care) Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No