<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/NCT04503018</url>
  </required_header>
  <id_info>
    <org_study_id>2019-06214</org_study_id>
    <nct_id>NCT04503018</nct_id>
  </id_info>
  <brief_title>Psychological Effects of Implant Loss</brief_title>
  <official_title>Psychological Effects of Implant Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vastra Gotaland Region</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>
      Previous quality of life studies have suggested that long term satisfaction with breast&#xD;
      reconstruction may be affected by postoperative complications. Complication frequencies,&#xD;
      especially the risk for implant loss, is considerably higher in immediate than in delayed&#xD;
      breast reconstruction. Knowledge about how implant loss affects the patient's experience of&#xD;
      her breast reconstruction can guide us in the choice between immediate and delayed breast&#xD;
      reconstruction in high risk patients and help us better prepare the patients for possible&#xD;
      complications. This study will investigate patients' experiences with losing an implant in&#xD;
      connection with immediate breast reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Experiences and psychological effects of implant loss after immediate breast reconstruction</measure>
    <time_frame>10 years</time_frame>
    <description>Interviews</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on quality of life of implant loss: scale</measure>
    <time_frame>10 years</time_frame>
    <description>Breast-Q reconstruction post-operative. It includes different domains: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100.a higher score means greater satisfaction or better QOL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on body image of implant loss</measure>
    <time_frame>10 years</time_frame>
    <description>Body-Esteem Scale for Adolescents and Adults (BESAA). It consists of three subscales: BE-appearance, BE-weight and BE-attribution.The scale has 23 items and the respondents indicated their degree of agreement on a 5-point Likert scale ranging from 0 (never) to 4 (always).High score indicates higher dimensions of the Body Esteem.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect on depression and anxiety of implant loss</measure>
    <time_frame>10 years</time_frame>
    <description>Hospital Anxiety and Depression scale (HAD).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coping strategies</measure>
    <time_frame>10 years</time_frame>
    <description>Brief-cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.Scores are presented for the two overarching coping styles: avoidant and approach.The scale can determine someone's primary coping styles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Coping strategies</measure>
    <time_frame>10 years</time_frame>
    <description>The Life orientation test - revised (Lot-R) is a 10-item scale that measures how optimistic or pessimistic people feel about the future. High values imply optimism.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Interviewed -implant loss</arm_group_label>
    <description>Patients who have had immediate breast reconstruction and lost the implant due to for example infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Questionnaires - implant loss</arm_group_label>
    <description>Patients who have had immediate breast reconstruction and lost the implant due to for example infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Questionnaires - controls</arm_group_label>
    <description>Patients who have had immediate breast reconstruction without complications</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Purposive criterion sampling technique is used. The population will identified through an&#xD;
        operation planning software&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biological women&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Have lost an implant after a mastectomy and immediate breast reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  inability to speak and understand Swedish&#xD;
&#xD;
          -  relapse of breast cancer after the reconstruction&#xD;
&#xD;
          -  metastatic disease&#xD;
&#xD;
          -  psychiatric co-morbidity.&#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>Emma Hansson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Västra Götaland</name>
      <address>
        <city>Gothenburg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emma Hansson, PhD</last_name>
      <phone>+46 31 342 10 00</phone>
      <email>emma.hansson.2@gu.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://liu.diva-portal.org/smash/get/diva2:1591756/FULLTEXT01.pdf</url>
    <description>Full text article</description>
  </link>
  <results_reference>
    <citation>Weick L, Ericson A, Sandman L, Bostrom P, Hansson E. Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis. Health Care Women Int. 2023 Jan;44(1):61-79. doi: 10.1080/07399332.2021.1944152. Epub 2021 Aug 24.</citation>
    <PMID>34427538</PMID>
  </results_reference>
  <results_reference>
    <citation>Weick L, Lunde C, Hansson E. The effect of implant loss after immediate breast reconstruction on patient satisfaction with outcome and quality of life after five years - a case-control study. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):263-270. doi: 10.1080/2000656X.2022.2061501. Epub 2022 Apr 15.</citation>
    <PMID>35427208</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast reconstruction</keyword>
  <keyword>Plastic surgery</keyword>
  <keyword>Psychology</keyword>
  <!-- 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/NCT04503018
org study id: 2019-06214
nct id: NCT04503018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous quality of life studies have suggested that long term satisfaction with breast
      reconstruction may be affected by postoperative complications. Complication frequencies,
      especially the risk for implant loss, is considerably higher in immediate than in delayed
      breast reconstruction. Knowledge about how implant loss affects the patient's experience of
      her breast reconstruction can guide us in the choice between immediate and delayed breast
      reconstruction in high risk patients and help us better prepare the patients for possible
      complications. This study will investigate patients' experiences with losing an implant in
      connection with immediate breast reconstruction.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Experiences and psychological effects of implant loss after immediate breast reconstruction
time frame: 10 years
description: Interviews
measure: Effect on quality of life of implant loss: scale
time frame: 10 years
description: Breast-Q reconstruction post-operative. It includes different domains: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100.a higher score means greater satisfaction or better QOL
measure: Effect on body image of implant loss
time frame: 10 years
description: Body-Esteem Scale for Adolescents and Adults (BESAA). It consists of three subscales: BE-appearance, BE-weight and BE-attribution.The scale has 23 items and the respondents indicated their degree of agreement on a 5-point Likert scale ranging from 0 (never) to 4 (always).High score indicates higher dimensions of the Body Esteem.
measure: Effect on depression and anxiety of implant loss
time frame: 10 years
description: Hospital Anxiety and Depression scale (HAD).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.
measure: Coping strategies
time frame: 10 years
description: Brief-cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.Scores are presented for the two overarching coping styles: avoidant and approach.The scale can determine someone's primary coping styles.
measure: Coping strategies
time frame: 10 years
description: The Life orientation test - revised (Lot-R) is a 10-item scale that measures how optimistic or pessimistic people feel about the future. High values imply optimism.
arm group label: Interviewed -implant loss
description: Patients who have had immediate breast reconstruction and lost the implant due to for example infection.
arm group label: Questionnaires - implant loss
description: Patients who have had immediate breast reconstruction and lost the implant due to for example infection.
arm group label: Questionnaires - controls
description: Patients who have had immediate breast reconstruction without complications
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emma Hansson, PhD
role: Principal Investigator
affiliation: Göteborg University
facility: 
status: Recruiting
contact: 
country: Sweden
url: http://liu.diva-portal.org/smash/get/diva2:1591756/FULLTEXT01.pdf
description: Full text article
citation: Weick L, Ericson A, Sandman L, Bostrom P, Hansson E. Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis. Health Care Women Int. 2023 Jan;44(1):61-79. doi: 10.1080/07399332.2021.1944152. Epub 2021 Aug 24.
PMID: 34427538
citation: Weick L, Lunde C, Hansson E. The effect of implant loss after immediate breast reconstruction on patient satisfaction with outcome and quality of life after five years - a case-control study. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):263-270. doi: 10.1080/2000656X.2022.2061501. Epub 2022 Apr 15.
PMID: 35427208
responsible party type: Sponsor