<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/NCT03791138</url>
  </required_header>
  <id_info>
    <org_study_id>NKI 2014-7031</org_study_id>
    <secondary_id>A6C/NKI 2014-7031</secondary_id>
    <nct_id>NCT03791138</nct_id>
  </id_info>
  <brief_title>The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction</brief_title>
  <acronym>TANGO</acronym>
  <official_title>The Impact of a Web-based Decision Aid for Women Considering Breast Reconstruction: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Netherlands Cancer Institute</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>
      This study evaluates the impact of an online patient decision aid on the process of decision&#xD;
      making regarding breast reconstruction and the decision quality in women with breast cancer&#xD;
      undergoing mastectomy and considering immediate breast reconstruction. Half of participants&#xD;
      will receive care as usual and access to the online decision aid, while the other half will&#xD;
      receive care as usual including a standard information leaflet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: In the Netherlands, of the approximately 15,000 women who are diagnosed with&#xD;
      breast cancer each year, about 40% undergo mastectomy. A wide variety of breast&#xD;
      reconstructive methods are offered to these women. In most cases, there is no clear medical&#xD;
      recommendation on which procedure is the best. Decisions for breast surgery and&#xD;
      reconstruction are frequently made during an emotionally burdensome and restricted timeframe.&#xD;
      Women may find it hard to make a decision for the type of surgery and reconstruction, some&#xD;
      feel that the decision is hurried and uninformed, and many have some degree of regret about&#xD;
      their decision at a later date. To support women in making a well-informed decision about&#xD;
      breast reconstruction, an online patient decision aid (pDA) has been developed.&#xD;
&#xD;
      Objective: The primary objective of the study is to evaluate the impact of the use of the&#xD;
      online pDA on the process of decision making regarding breast reconstruction and the decision&#xD;
      quality. The secondary objective of the study is to evaluate the impact of the use of the&#xD;
      online pDA on patient reported health outcomes, to identify possible moderators of the&#xD;
      effect, and to investigate the cost-effectiveness.&#xD;
&#xD;
      Hypotheses: It is hypothesized that the online pDA, as compared to usual care, will improve&#xD;
      the decision making process about breast reconstruction (i.e. leads to less decisional&#xD;
      conflict, higher satisfaction with information, higher levels of preparedness for decision&#xD;
      making and higher perceived levels of shared decision making) and that it will improve the&#xD;
      decision quality (i.e. leads to higher levels of knowledge about breast reconstruction and&#xD;
      lower levels of regret).&#xD;
&#xD;
      Study design: A multicenter randomized controlled trial (RCT) will be performed in eight&#xD;
      hospitals. All consenting participants will be randomized into one of the two study arms&#xD;
      (intervention group or control group). Women in both groups will be invited to complete&#xD;
      questionnaires at baseline (i.e. before randomization), 1 week after consultation with a&#xD;
      plastic surgeon and 3 and 12 months after breast surgery.&#xD;
&#xD;
      Study population: 250 women will participate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">October 8, 2020</completion_date>
  <primary_completion_date type="Actual">May 28, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>decisional conflict</measure>
    <time_frame>1 week after consultation with a plastic surgeon (T1)</time_frame>
    <description>decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>decisional conflict</measure>
    <time_frame>3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decision regret</measure>
    <time_frame>3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>decision regret scale (DRS); the DRS consists of 5 items, rated on a 5 point Likert-type scale (strongly agree - strongly disagree). Scores range from 0 - 100, with higher scores indicating higher levels of regret.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>knowledge about breast reconstruction</measure>
    <time_frame>1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>study-specific questionnaire consisting of 10 items (true/false/I don't know)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>preparedness for decision making</measure>
    <time_frame>1 week after consultation with a plastic surgeon (T1)</time_frame>
    <description>preparation for decision making scale; 10 items, rated on a 5-point Likert-type scale (Not at all - a great deal). Scores range from 0 - 100, with higher scores indicating higher perceived level of preparation for decision making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction with information</measure>
    <time_frame>1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>three study-specific questions (a. How satisfied are you with the information about breast reconstruction? (5 point Likert-scale: not at all - very satisfied), b. Did you miss information? (yes/no), and c. Would you have preferred less information? (yes/no)). The subsample of women who opted for breast reconstruction will also complete the Satisfaction with Information-subscale of the Breast-Q (14 items, 4 point Likert-type scale, very dissatisfied - very satisfied, scores range from 0 -100, with higher scores indicating higher levels of satisfaction with information).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's perception of shared decision making</measure>
    <time_frame>1 week after consultation with a plastic surgeon (T1)</time_frame>
    <description>shared decision making questionnaire (SDM-Q-9); the SDM-Q-9 consists of 9 items, rated on a 6 point Likert-type scale (completely disagree - completely agree). The sum of all items (score between 0 - 45) will be multiplied by 20/9 to transform scores to range from 0 -100, where 0 indicates the lowest possible level of shared decision making and 100 indicates the highest extent of shared decision making.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction with plastic surgeon</measure>
    <time_frame>1 week after consultation with plastic surgeon (T1)</time_frame>
    <description>The subscale Satisfaction with Surgeon of the Breast-Q consists of 12 items, rated on a 4 point Likert-type scale (completely disagree - completely agree). Scores range from 0 - 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>actual choice</measure>
    <time_frame>3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>actual choice about breast reconstruction (self-reported and verified against patients' medical records)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction with outcome</measure>
    <time_frame>3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>The Breast-Q subscale Satisfaction with Breast measures body image in terms of a woman's satisfaction with her breasts. It consists of 4 to 16 items (depending on the type of surgery), rated on a 4 point Likert-type scale (very dissatisfied - very satisfied). The subsample of women who opted for breast reconstruction also completes the Breast-Q subscale Satisfaction with Breast Outcome (7 items, 3 point Likert-type scale (disagree - completely agree)), measuring a woman's overall appraisal of the outcome of her breast surgery. For both subscales, scores range from 0 -100, with higher scores indicating higher satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body image</measure>
    <time_frame>3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>Subscale Body Image of the EORTC QLQ-BR23 (4 items, 4 point likert-type scale (not at all - very much), scores range from: 0-100 , a higher score is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sexual functioning</measure>
    <time_frame>3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>Subscales of Sexual Functioning (2 items) and Sexual Enjoyment (1 item) of the EORTC-QLQ BR23. Both subscale are rated on a 4 point Likert-type scale (not at all - very much). Scores range from 0-100, a higher score is better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>breast symptoms</measure>
    <time_frame>3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>Subscale Breast Symptoms (4 items, 4 point Likert-type scale, not at all - very much) of the EORTC QLQ-BR23. Scores range from 0-100, a higher score is worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety</measure>
    <time_frame>1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)</time_frame>
    <description>The short-form of the state scale of the spielberger state-trait anxiety inventory (STAI), consisting of 6 items, rated on a 4 point Likert-type scale (not at all - very much). Scores range from 20 - 80, with higher scores indicating higher levels of anxiety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Care as usual and an online patient decision aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Care as usual with a standard information leaflet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>online patient decision aid</intervention_name>
    <description>An online, interactive tool that can be used to prepare for consultation with a plastic surgeon which contains evidence-based information about breast reconstruction options, the pros and cons of the options, value clarification exercises and patient narratives. It results in a summary sheet with patients' personal values and questions that can be discussed during consultation with a plastic surgeon.</description>
    <arm_group_label>intervention group</arm_group_label>
    <other_name>Breast Reconstruction Decision Aid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female (≥18 years);&#xD;
&#xD;
          -  diagnosed with breast cancer or carcinoma in situ;&#xD;
&#xD;
          -  will be treated with mastectomy and is eligible for immediate breast reconstruction;&#xD;
&#xD;
          -  is referred to a plastic surgeon (consultation takes place ≥3 working days after study&#xD;
             invitation);&#xD;
&#xD;
          -  has internet access and sufficient computer skills;&#xD;
&#xD;
          -  is able to read and speak the Dutch language.&#xD;
&#xD;
        Exclusion Criteria: None&#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>Eveline MA Bleiker, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Netherlands Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meander Medical Center</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Slotervaart</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netherlands Cancer Institute</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf Gasthuis</name>
      <address>
        <city>Delft</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscus Gasthuis &amp; Vlietland</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast reconstruction</keyword>
  <keyword>patient decision aid</keyword>
  <keyword>decisional conflict</keyword>
  <keyword>randomized controlled trial</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/NCT03791138
org study id: NKI 2014-7031
secondary id: A6C/NKI 2014-7031
nct id: NCT03791138
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of an online patient decision aid on the process of decision
      making regarding breast reconstruction and the decision quality in women with breast cancer
      undergoing mastectomy and considering immediate breast reconstruction. Half of participants
      will receive care as usual and access to the online decision aid, while the other half will
      receive care as usual including a standard information leaflet.
Rationale: In the Netherlands, of the approximately 15,000 women who are diagnosed with
      breast cancer each year, about 40% undergo mastectomy. A wide variety of breast
      reconstructive methods are offered to these women. In most cases, there is no clear medical
      recommendation on which procedure is the best. Decisions for breast surgery and
      reconstruction are frequently made during an emotionally burdensome and restricted timeframe.
      Women may find it hard to make a decision for the type of surgery and reconstruction, some
      feel that the decision is hurried and uninformed, and many have some degree of regret about
      their decision at a later date. To support women in making a well-informed decision about
      breast reconstruction, an online patient decision aid (pDA) has been developed.

      Objective: The primary objective of the study is to evaluate the impact of the use of the
      online pDA on the process of decision making regarding breast reconstruction and the decision
      quality. The secondary objective of the study is to evaluate the impact of the use of the
      online pDA on patient reported health outcomes, to identify possible moderators of the
      effect, and to investigate the cost-effectiveness.

      Hypotheses: It is hypothesized that the online pDA, as compared to usual care, will improve
      the decision making process about breast reconstruction (i.e. leads to less decisional
      conflict, higher satisfaction with information, higher levels of preparedness for decision
      making and higher perceived levels of shared decision making) and that it will improve the
      decision quality (i.e. leads to higher levels of knowledge about breast reconstruction and
      lower levels of regret).

      Study design: A multicenter randomized controlled trial (RCT) will be performed in eight
      hospitals. All consenting participants will be randomized into one of the two study arms
      (intervention group or control group). Women in both groups will be invited to complete
      questionnaires at baseline (i.e. before randomization), 1 week after consultation with a
      plastic surgeon and 3 and 12 months after breast surgery.

      Study population: 250 women will participate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: decisional conflict
time frame: 1 week after consultation with a plastic surgeon (T1)
description: decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict.
measure: decisional conflict
time frame: 3 months after surgery (T2); 12 months after surgery (T3)
description: decisional conflict scale (DCS); the DCS consists of a total score and five subscales (uncertainty, feeling informed, feeling clear about values, feeling supported and effective decision-making). It consists of 16 items which are rated on a 5-point Likert-type scale (strongly agree- strongly disagree). Scores range from 0 - 100, with higher scores indicating more decisional conflict.
measure: decision regret
time frame: 3 months after surgery (T2); 12 months after surgery (T3)
description: decision regret scale (DRS); the DRS consists of 5 items, rated on a 5 point Likert-type scale (strongly agree - strongly disagree). Scores range from 0 - 100, with higher scores indicating higher levels of regret.
measure: knowledge about breast reconstruction
time frame: 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
description: study-specific questionnaire consisting of 10 items (true/false/I don't know)
measure: preparedness for decision making
time frame: 1 week after consultation with a plastic surgeon (T1)
description: preparation for decision making scale; 10 items, rated on a 5-point Likert-type scale (Not at all - a great deal). Scores range from 0 - 100, with higher scores indicating higher perceived level of preparation for decision making.
measure: satisfaction with information
time frame: 1 week after consultation with plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
description: three study-specific questions (a. How satisfied are you with the information about breast reconstruction? (5 point Likert-scale: not at all - very satisfied), b. Did you miss information? (yes/no), and c. Would you have preferred less information? (yes/no)). The subsample of women who opted for breast reconstruction will also complete the Satisfaction with Information-subscale of the Breast-Q (14 items, 4 point Likert-type scale, very dissatisfied - very satisfied, scores range from 0 -100, with higher scores indicating higher levels of satisfaction with information).
measure: patient's perception of shared decision making
time frame: 1 week after consultation with a plastic surgeon (T1)
description: shared decision making questionnaire (SDM-Q-9); the SDM-Q-9 consists of 9 items, rated on a 6 point Likert-type scale (completely disagree - completely agree). The sum of all items (score between 0 - 45) will be multiplied by 20/9 to transform scores to range from 0 -100, where 0 indicates the lowest possible level of shared decision making and 100 indicates the highest extent of shared decision making.
measure: satisfaction with plastic surgeon
time frame: 1 week after consultation with plastic surgeon (T1)
description: The subscale Satisfaction with Surgeon of the Breast-Q consists of 12 items, rated on a 4 point Likert-type scale (completely disagree - completely agree). Scores range from 0 - 100.
measure: actual choice
time frame: 3 months after surgery (T2); 12 months after surgery (T3)
description: actual choice about breast reconstruction (self-reported and verified against patients' medical records)
measure: satisfaction with outcome
time frame: 3 months after surgery (T2); 12 months after surgery (T3)
description: The Breast-Q subscale Satisfaction with Breast measures body image in terms of a woman's satisfaction with her breasts. It consists of 4 to 16 items (depending on the type of surgery), rated on a 4 point Likert-type scale (very dissatisfied - very satisfied). The subsample of women who opted for breast reconstruction also completes the Breast-Q subscale Satisfaction with Breast Outcome (7 items, 3 point Likert-type scale (disagree - completely agree)), measuring a woman's overall appraisal of the outcome of her breast surgery. For both subscales, scores range from 0 -100, with higher scores indicating higher satisfaction.
measure: body image
time frame: 3 months after surgery (T2); 12 months after surgery (T3)
description: Subscale Body Image of the EORTC QLQ-BR23 (4 items, 4 point likert-type scale (not at all - very much), scores range from: 0-100 , a higher score is better.
measure: sexual functioning
time frame: 3 months after surgery (T2); 12 months after surgery (T3)
description: Subscales of Sexual Functioning (2 items) and Sexual Enjoyment (1 item) of the EORTC-QLQ BR23. Both subscale are rated on a 4 point Likert-type scale (not at all - very much). Scores range from 0-100, a higher score is better.
measure: breast symptoms
time frame: 3 months after surgery (T2); 12 months after surgery (T3)
description: Subscale Breast Symptoms (4 items, 4 point Likert-type scale, not at all - very much) of the EORTC QLQ-BR23. Scores range from 0-100, a higher score is worse.
measure: anxiety
time frame: 1 week after consultation with a plastic surgeon (T1); 3 months after surgery (T2); 12 months after surgery (T3)
description: The short-form of the state scale of the spielberger state-trait anxiety inventory (STAI), consisting of 6 items, rated on a 4 point Likert-type scale (not at all - very much). Scores range from 20 - 80, with higher scores indicating higher levels of anxiety.
arm group label: intervention group
arm group type: Experimental
description: Care as usual and an online patient decision aid
arm group label: control group
arm group type: No Intervention
description: Care as usual with a standard information leaflet
intervention type: Other
intervention name: online patient decision aid
description: An online, interactive tool that can be used to prepare for consultation with a plastic surgeon which contains evidence-based information about breast reconstruction options, the pros and cons of the options, value clarification exercises and patient narratives. It results in a summary sheet with patients' personal values and questions that can be discussed during consultation with a plastic surgeon.
arm group label: intervention group
other name: Breast Reconstruction Decision Aid
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eveline MA Bleiker, Professor
role: Principal Investigator
affiliation: The Netherlands Cancer Institute
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No