<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/NCT01727635</url>
  </required_header>
  <id_info>
    <org_study_id>200909010R</org_study_id>
    <nct_id>NCT01727635</nct_id>
  </id_info>
  <brief_title>The Long-term Effects of Body-mind-spirit Group Therapy</brief_title>
  <official_title>The Long-term Effects of Body-mind-spirit Group Therapy on Close Relationships, Sleeping Quality, Depression, Quality of Life, Meaning of Life, and Saliva Cortisol Responses in Breast Cancer Survivors and Partners</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims and objectives: This study aims to examine the effects of the body-mind-spirit group&#xD;
      therapy on marital close relationships, sleeping quality, depression, quality of life,&#xD;
      meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and&#xD;
      partners.&#xD;
&#xD;
      Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast&#xD;
      cancer survivors will be recruited from outpatient department of surgical at hospital. The&#xD;
      partners will be invited to participate in this study through the survivors. The 120 dyad&#xD;
      survivors and spouse will be randomly assigned into an experimental group or a control group.&#xD;
      Survivors and spouse partners in an experimental group will receive 2 months time&#xD;
      body-mind-spirit group therapy while those in a control will receive usual care in the same&#xD;
      period of time. The outcome measures include Experiences in close relationships scale, Moss&#xD;
      sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life&#xD;
      questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points&#xD;
      include pre intervention, post intervention (after 8 weekly group therapy), &amp; then 3, 6, 12&#xD;
      months after the end of intervention for the maintenance effect. Univariate analyses will be&#xD;
      performed to explore the basic characteristics of participants. The hierarchical linear model&#xD;
      will be used to test the hypothesis the improvement is higher in intervention group than the&#xD;
      control group in the effects of marital close relationships, sleeping quality, depression,&#xD;
      meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer&#xD;
      survivors and partners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims and objectives: This study aims to examine the effects of the body-mind-spirit group&#xD;
      therapy on marital close relationships, sleeping quality, depression, quality of life,&#xD;
      meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and&#xD;
      partners. Methods: The design adopts the randomized controlled trial (RCT). The metastatic&#xD;
      breast cancer survivors will be recruited from outpatient department of surgical at hospital.&#xD;
      The partners will be invited to participate in this study through the survivors. The 120 dyad&#xD;
      survivors and spouse will be randomly assigned into an experimental group or a control group.&#xD;
      Survivors and spouse partners in an experimental group will receive 2 months time&#xD;
      body-mind-spirit group therapy while those in a control will receive usual care in the same&#xD;
      period of time. The outcome measures include Experiences in close relationships scale, Moss&#xD;
      sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life&#xD;
      questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points&#xD;
      include pre intervention, post intervention (after 8 weekly group therapy), &amp; then 3, 6, 12&#xD;
      months after the end of intervention for the maintenance effect. Univariate analyses will be&#xD;
      performed to explore the basic characteristics of participants. The hierarchical linear model&#xD;
      will be used to test the hypothesis the improvement is higher in intervention group than the&#xD;
      control group in the effects of marital close relationships, sleeping quality, depression,&#xD;
      meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer&#xD;
      survivors and partners.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diurnal Cortisol patterns</measure>
    <time_frame>pre, post, 3months, 6months and 1year after end of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Experiences in Close Relationships-Revised questionnaire</measure>
    <time_frame>pre, post, 3months, 6months and 1year after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>pre, post, 3months, 6months and 1year after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>pre, post, 3months, 6months and 1year after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MOS sleep scale</measure>
    <time_frame>pre, post, 3months, 6months and 1year after end of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meaning in Life Questionnaire</measure>
    <time_frame>pre, post, 3months, 6months and 1year after end of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Depression</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>body-mind-spirit group therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>body-mind-spirit group therapy</intervention_name>
    <description>8-session therapy</description>
    <arm_group_label>counseling</arm_group_label>
    <other_name>group therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria of Survivors:&#xD;
&#xD;
          1. breast cancer patients who complete active treatments,&#xD;
&#xD;
          2. those who are willing to participate in the research,&#xD;
&#xD;
          3. those who currently do not receive any individual or group psychotherapy, AND&#xD;
&#xD;
          4. aged between 18 and 65.&#xD;
&#xD;
        Inclusion criteria of Spouse partners:&#xD;
&#xD;
          1. partners of breast cancer patient who complete active treatments,&#xD;
&#xD;
          2. those who are willing to participate in the research,&#xD;
&#xD;
          3. those who currently do not receive any individual or group psychotherapy, AND&#xD;
&#xD;
          4. aged between 18 and 65.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria of Survivors:&#xD;
&#xD;
          1. diagnosed as both breast cancer and other types of cancers,&#xD;
&#xD;
          2. those with adrenal function disorders (for example, Cushing syndrome, Addison's&#xD;
             disease, adrenal tumor, pituitary tumor), OR&#xD;
&#xD;
          3. those who currently use antidepressants.&#xD;
&#xD;
        Exclusion criteria of Survivors:&#xD;
&#xD;
          1. diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's&#xD;
             disease, adrenal tumor, pituitary tumor), OR&#xD;
&#xD;
          2. those who currently use antidepressants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fei Hsiao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nursing, College of Medicine, National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <zip>10051</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 21, 2009</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer, survivors, partners, group therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727635
org study id: 200909010R
nct id: NCT01727635
lead sponsor: 
has dmc: No
Aims and objectives: This study aims to examine the effects of the body-mind-spirit group
      therapy on marital close relationships, sleeping quality, depression, quality of life,
      meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and
      partners.

      Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast
      cancer survivors will be recruited from outpatient department of surgical at hospital. The
      partners will be invited to participate in this study through the survivors. The 120 dyad
      survivors and spouse will be randomly assigned into an experimental group or a control group.
      Survivors and spouse partners in an experimental group will receive 2 months time
      body-mind-spirit group therapy while those in a control will receive usual care in the same
      period of time. The outcome measures include Experiences in close relationships scale, Moss
      sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life
      questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points
      include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12
      months after the end of intervention for the maintenance effect. Univariate analyses will be
      performed to explore the basic characteristics of participants. The hierarchical linear model
      will be used to test the hypothesis the improvement is higher in intervention group than the
      control group in the effects of marital close relationships, sleeping quality, depression,
      meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer
      survivors and partners.
Aims and objectives: This study aims to examine the effects of the body-mind-spirit group
      therapy on marital close relationships, sleeping quality, depression, quality of life,
      meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and
      partners. Methods: The design adopts the randomized controlled trial (RCT). The metastatic
      breast cancer survivors will be recruited from outpatient department of surgical at hospital.
      The partners will be invited to participate in this study through the survivors. The 120 dyad
      survivors and spouse will be randomly assigned into an experimental group or a control group.
      Survivors and spouse partners in an experimental group will receive 2 months time
      body-mind-spirit group therapy while those in a control will receive usual care in the same
      period of time. The outcome measures include Experiences in close relationships scale, Moss
      sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life
      questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points
      include pre intervention, post intervention (after 8 weekly group therapy), & then 3, 6, 12
      months after the end of intervention for the maintenance effect. Univariate analyses will be
      performed to explore the basic characteristics of participants. The hierarchical linear model
      will be used to test the hypothesis the improvement is higher in intervention group than the
      control group in the effects of marital close relationships, sleeping quality, depression,
      meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer
      survivors and partners.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Diurnal Cortisol patterns
time frame: pre, post, 3months, 6months and 1year after end of treatment
measure: The Experiences in Close Relationships-Revised questionnaire
time frame: pre, post, 3months, 6months and 1year after end of treatment
measure: Beck Depression Inventory
time frame: pre, post, 3months, 6months and 1year after end of treatment
measure: Quality of life
time frame: pre, post, 3months, 6months and 1year after end of treatment
measure: MOS sleep scale
time frame: pre, post, 3months, 6months and 1year after end of treatment
measure: Meaning in Life Questionnaire
time frame: pre, post, 3months, 6months and 1year after end of treatment
arm group label: counseling
arm group type: Experimental
description: body-mind-spirit group therapy
intervention type: Other
intervention name: body-mind-spirit group therapy
description: 8-session therapy
arm group label: counseling
other name: group therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Fei Hsiao, PhD
role: Principal Investigator
affiliation: National Taiwan University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Depression