<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/NCT03026374</url>
  </required_header>
  <id_info>
    <org_study_id>ZYZC20160901</org_study_id>
    <secondary_id>ZYZC20160901</secondary_id>
    <nct_id>NCT03026374</nct_id>
  </id_info>
  <brief_title>Effect of a Mentor-based, Supportive-expressive Program on Survival in Metastatic Breast Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new&#xD;
      malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with&#xD;
      breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide.&#xD;
      Additionally, 30% of early breast cancer turns metastatic, which is often incurable.&#xD;
      Different from women with early breast cancer, women with metastatic breast cancer(MBC)must&#xD;
      receive lifelong treatment, experience higher levels of emotional/physical distress, and feel&#xD;
      frequent uncertainty about their health/possible death. They are also challenged to manage&#xD;
      distressing adverse effects induced by different adjuvant treatments and experience heavy&#xD;
      self-care demands during the transition period from being a patient to being a survivor.&#xD;
      Thus, specific interventions to help women with metastatic breast cancer to recover from this&#xD;
      traumatic event have been designed, and one of these is supportive-expressive group&#xD;
      therapy(SEGT).SEGT has been found to achieve improvement in anxiety, depression, quality of&#xD;
      life (QoL), family functioning, and satisfaction with treatment. However, the effect of SEGT&#xD;
      on survival is inconsistent. Initial studies examining SEGT have reported a mean survival&#xD;
      advantage of 18 months, however, these findings could not later be replicated.Yet, no study&#xD;
      has reported a survival disadvantage for those given SEGT. In addition, we found no published&#xD;
      articles on the application of SEGT among women with MBC in China. Owing to this dearth of&#xD;
      previous research, it is unclear whether this therapy would exhibit positive effects within&#xD;
      Chinese culture. Thus, we developed a &quot;Be Resilient to Breast Cancer&quot;(BRBC) program that is&#xD;
      culturally tailored for Chinese females with MBC. This program was adapted from SEGT and is&#xD;
      designed to increase resilience(defined as the capacity to bounce back after encountering a&#xD;
      traumatic event) and QoL, decrease emotional and physical distress(allostatic load), and&#xD;
      eventually prolong longevity. To better adapt to Chinese culture, we added education hosted&#xD;
      by professional staff (e.g., clinical psychologists, dietician, Chinese medicine&#xD;
      practitioner, etc.)in an effort to foster self-efficacy to combat symptoms (such as pain,&#xD;
      fatigue, intrusive thoughts, etc.) through knowledge and technics (such as breath control,&#xD;
      meditation, etc.),and to help patients gain a sense of control in their life. Second, trained&#xD;
      mentors, who were breast cancer survivors themselves, were added to the group discussion to&#xD;
      create non-hierarchical, reciprocal relationships through the sharing of experiences with&#xD;
      those facing similar challenges. These mentors also provided women with first-hand&#xD;
      information about treatment and offered suggestions to combat barriers to recovery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>June 2017</start_date>
  <primary_completion_date type="Anticipated">June 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3- and 5-year survival</measure>
    <time_frame>3 and 5 years since intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>allostatic load index(ALI)</measure>
    <time_frame>baseline, 2 months, 6 months, and 12 months since intervention</time_frame>
    <description>ALI was a composite index measured by 14 indicators from different physiological systems, including body mass index (BMI), waist-hip ratio (WHR), resting pulse(RP), the standard deviation of R-R intervals (SDRR, heartbeat to heartbeat), resting systolicand diastolic blood pressure(SBP and DBP, respectively), white blood cell count (WBC), red blood cell count (RBC), hemoglobin, serotonin, hormone cortisol(HC), C-reactive protein(CRP), interleukin-6 (IL-6) and Cluster of Differentiation 4/ Cluster of Differentiation 8(CD4+/CD8+). These indicators were selected to evaluate the functions of sympathetic nervous system (SNS), parasympathetic nervous system (PNS), hypothalamic pituitary adrenal (HPA), cardiovascular, inflammation, and immunization. If a physical indicator was diagnosed as abnormal (i.e., RP of 107; normal range 60-100), patient would receive 1 point. Higher point totals indicated higher allostatic load. ALI range was from 0(extremely low) to 14(extremely high).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>baseline, 2 months, 6 months, and 12 months since intervention</time_frame>
    <description>Resilience was measured by the 10 item Conner-Davison Resilience Scale (CD-RISC-10), which is a self-administered questionnaire based on a 5-point scale, with higher scores reflecting more resilience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>baseline, 2 months, 6 months, and 12 months since intervention</time_frame>
    <description>QoL was measured by QLQ-C30 core questionnaire of the European Organization for Research and Treatment of Cancer (EORTC), which contains 30 items pertaining to different patient QoL aspects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>baseline, 2 months, 6 months, and 12 months since intervention</time_frame>
    <description>Anxiety was measured by the Chinese version of Hospital Anxiety and Depression Scale (HADS), which contains 7 items for anxiety and 7 items for depression, respectively, scored on a 5-point scale. Higher scores indicate higher levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>baseline, 2 months, 6 months, and 12 months since intervention</time_frame>
    <description>Depression was measured by the Chinese version of Hospital Anxiety and Depression Scale (HADS), which contains 7 items for anxiety and 7 items for depression, respectively, scored on a 5-point scale. Higher scores indicate higher levels of depression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">204</enrollment>
  <condition>Metastatic Breastcancer</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The BRBC program consists of education and group discussion, and lasted for 12 months. Women in IG attended weekly meetings lasting for 120 minutes. Education took approximately 45 minute. Qualified professionals from various disciplines were invited to provide lessons to ensure the quality of the educational sessions. The group discussion followed the presentation and began with mentors sharing their experience with the topic, followed by participant discussions regarding life changes since diagnosis (e.g., physical, emotional, social, spiritual). Each group consisted of 7-9 patients and 3 leaders (2 mentors and 1 facilitator, including a clinical psychologist, nurse clinician, or social worker). The time of group discussion varied from 45-75 minutes. This was intended to foster support among group members,both in and out of sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients from both groups were provided medical, social, or psychological care if necessary, as assessed by primary oncologists. Additionally, all patients received an educational brochure about breast cancer every 1 to 2 months, and relaxation therapy was provided to both groups to prevent demoralization from random assignment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Be Resilient to Breast Cancer</intervention_name>
    <description>This is a supportive-expressive group therapy.</description>
    <arm_group_label>intervention group</arm_group_label>
    <other_name>BRBC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) women with confirmed breast cancer, stratified by stage(II,III, and IV),(2)&#xD;
             metastases outside of the breast and ipsilateral axilla, and (3) fluent in oral&#xD;
             Mandarin or Cantonese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) central nervous system metastases, (2) a history of repeated suicidal behavior,&#xD;
             (3) active psychosis or severe character disorder, (4) a life expectancy of less than&#xD;
             3 months(as assessed by primary oncologist), and/or (5)declined to participate in the&#xD;
             program&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zeng Jie Ye</name>
      <address>
        <city>Guangzhou Shi</city>
        <state>Guangdong</state>
        <zip>510006</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zeng Jie Ye</last_name>
      <phone>13427583750</phone>
      <email>1047052548@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Zeng Jie Ye</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>psychosocial support</keyword>
  <keyword>resilience</keyword>
  <keyword>metastatic breast cancer</keyword>
  <keyword>survival</keyword>
  <keyword>Quality of Life</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>Undecided</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/NCT03026374
org study id: ZYZC20160901
secondary id: ZYZC20160901
nct id: NCT03026374
lead sponsor: 
has dmc: Yes
Breast cancer is the most prevalent cancer in women and annually accounts for 10% of new
      malignancies worldwide. In mainland China, approximately 169,000 females are diagnosed with
      breast cancer every year and constitute 12.25% of the breast cancer incidents worldwide.
      Additionally, 30% of early breast cancer turns metastatic, which is often incurable.
      Different from women with early breast cancer, women with metastatic breast cancer(MBC)must
      receive lifelong treatment, experience higher levels of emotional/physical distress, and feel
      frequent uncertainty about their health/possible death. They are also challenged to manage
      distressing adverse effects induced by different adjuvant treatments and experience heavy
      self-care demands during the transition period from being a patient to being a survivor.
      Thus, specific interventions to help women with metastatic breast cancer to recover from this
      traumatic event have been designed, and one of these is supportive-expressive group
      therapy(SEGT).SEGT has been found to achieve improvement in anxiety, depression, quality of
      life (QoL), family functioning, and satisfaction with treatment. However, the effect of SEGT
      on survival is inconsistent. Initial studies examining SEGT have reported a mean survival
      advantage of 18 months, however, these findings could not later be replicated.Yet, no study
      has reported a survival disadvantage for those given SEGT. In addition, we found no published
      articles on the application of SEGT among women with MBC in China. Owing to this dearth of
      previous research, it is unclear whether this therapy would exhibit positive effects within
      Chinese culture. Thus, we developed a "Be Resilient to Breast Cancer"(BRBC) program that is
      culturally tailored for Chinese females with MBC. This program was adapted from SEGT and is
      designed to increase resilience(defined as the capacity to bounce back after encountering a
      traumatic event) and QoL, decrease emotional and physical distress(allostatic load), and
      eventually prolong longevity. To better adapt to Chinese culture, we added education hosted
      by professional staff (e.g., clinical psychologists, dietician, Chinese medicine
      practitioner, etc.)in an effort to foster self-efficacy to combat symptoms (such as pain,
      fatigue, intrusive thoughts, etc.) through knowledge and technics (such as breath control,
      meditation, etc.),and to help patients gain a sense of control in their life. Second, trained
      mentors, who were breast cancer survivors themselves, were added to the group discussion to
      create non-hierarchical, reciprocal relationships through the sharing of experiences with
      those facing similar challenges. These mentors also provided women with first-hand
      information about treatment and offered suggestions to combat barriers to recovery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: 3- and 5-year survival
time frame: 3 and 5 years since intervention
measure: allostatic load index(ALI)
time frame: baseline, 2 months, 6 months, and 12 months since intervention
description: ALI was a composite index measured by 14 indicators from different physiological systems, including body mass index (BMI), waist-hip ratio (WHR), resting pulse(RP), the standard deviation of R-R intervals (SDRR, heartbeat to heartbeat), resting systolicand diastolic blood pressure(SBP and DBP, respectively), white blood cell count (WBC), red blood cell count (RBC), hemoglobin, serotonin, hormone cortisol(HC), C-reactive protein(CRP), interleukin-6 (IL-6) and Cluster of Differentiation 4/ Cluster of Differentiation 8(CD4+/CD8+). These indicators were selected to evaluate the functions of sympathetic nervous system (SNS), parasympathetic nervous system (PNS), hypothalamic pituitary adrenal (HPA), cardiovascular, inflammation, and immunization. If a physical indicator was diagnosed as abnormal (i.e., RP of 107; normal range 60-100), patient would receive 1 point. Higher point totals indicated higher allostatic load. ALI range was from 0(extremely low) to 14(extremely high).
measure: Resilience
time frame: baseline, 2 months, 6 months, and 12 months since intervention
description: Resilience was measured by the 10 item Conner-Davison Resilience Scale (CD-RISC-10), which is a self-administered questionnaire based on a 5-point scale, with higher scores reflecting more resilience.
measure: Quality of Life
time frame: baseline, 2 months, 6 months, and 12 months since intervention
description: QoL was measured by QLQ-C30 core questionnaire of the European Organization for Research and Treatment of Cancer (EORTC), which contains 30 items pertaining to different patient QoL aspects.
measure: Anxiety
time frame: baseline, 2 months, 6 months, and 12 months since intervention
description: Anxiety was measured by the Chinese version of Hospital Anxiety and Depression Scale (HADS), which contains 7 items for anxiety and 7 items for depression, respectively, scored on a 5-point scale. Higher scores indicate higher levels of anxiety.
measure: Depression
time frame: baseline, 2 months, 6 months, and 12 months since intervention
description: Depression was measured by the Chinese version of Hospital Anxiety and Depression Scale (HADS), which contains 7 items for anxiety and 7 items for depression, respectively, scored on a 5-point scale. Higher scores indicate higher levels of depression.
arm group label: intervention group
arm group type: Experimental
description: The BRBC program consists of education and group discussion, and lasted for 12 months. Women in IG attended weekly meetings lasting for 120 minutes. Education took approximately 45 minute. Qualified professionals from various disciplines were invited to provide lessons to ensure the quality of the educational sessions. The group discussion followed the presentation and began with mentors sharing their experience with the topic, followed by participant discussions regarding life changes since diagnosis (e.g., physical, emotional, social, spiritual). Each group consisted of 7-9 patients and 3 leaders (2 mentors and 1 facilitator, including a clinical psychologist, nurse clinician, or social worker). The time of group discussion varied from 45-75 minutes. This was intended to foster support among group members,both in and out of sessions.
arm group label: control group
arm group type: No Intervention
description: patients from both groups were provided medical, social, or psychological care if necessary, as assessed by primary oncologists. Additionally, all patients received an educational brochure about breast cancer every 1 to 2 months, and relaxation therapy was provided to both groups to prevent demoralization from random assignment.
intervention type: Behavioral
intervention name: Be Resilient to Breast Cancer
description: This is a supportive-expressive group therapy.
arm group label: intervention group
other name: BRBC
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
investigator full name: Zeng Jie Ye
investigator title: Doctor
mesh term: Breast Neoplasms
sharing ipd: Undecided