xml: <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/NCT06015932</url>
    </required_header>
    <id_info>
      <org_study_id>17-000947</org_study_id>
      <secondary_id>NCI-2023-00250</secondary_id>
      <secondary_id>17-000947</secondary_id>
      <nct_id>NCT06015932</nct_id>
    </id_info>
    <brief_title>Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients</brief_title>
    <official_title>A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>Yes</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 clinical trial tests how well cognitive behavioral cancer stress management (CBCSM)&#xD;
        group sessions work to decrease psychological distress in cancer patients. CBCSM teaches&#xD;
        patients how to recognize and reduce the impacts of cancer associated stress on the&#xD;
        biological, psychological, and social life domains.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To reduce psychological stress.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in&#xD;
        utilizing therapy skills. III. To estimate patient acceptability and feasibility of&#xD;
        conducting CBCSM within the clinical setting.&#xD;
  &#xD;
        OUTLINE: Patients are assigned to 1 of 2 groups.&#xD;
  &#xD;
        GROUP I: Patients participate in five CBCSM group sessions on study. Patients complete&#xD;
        questionnaires throughout the trial.&#xD;
  &#xD;
        GROUP II: Patients complete questionnaires throughout the trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 20, 2017</start_date>
    <completion_date type="Anticipated">December 2029</completion_date>
    <primary_completion_date type="Anticipated">December 2029</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-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>Change in post-traumatic stress (PTS) score</measure>
      <time_frame>At baseline, 1, 3, 6, and 12 months</time_frame>
      <description>Utilizing linear regression, intervention group membership (cognitive behavioral cancer stress management [Cognitive Behavioral Cancer Stress Management (CBCSM)] cases vs. control group) will be entered as the independent variable. PTS-change scores (post-intervention score - pre-intervention score) will be entered as the dependent variable. Covariates significantly associated with PTS score in univariate analyses and baseline PTS will be entered into the regression equation. P-values &lt; .05 are significant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in post-traumatic growth (PTG) score</measure>
      <time_frame>At baseline, 1, 3, 6, and 12 months</time_frame>
      <description>Will examine predicted reductions in PTG associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be measured using the Patient-Reported Outcomes Measurement System (PROMIS®)-Psychosocial Impact Scale-Positive .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-efficacy score</measure>
      <time_frame>At baseline, 1, 3, 6, and 12 months</time_frame>
      <description>Will examine predicted increase in self-efficacy associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be assessed using the Measure of Current Status-Part A (MOCS-A).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient acceptability and satisfaction</measure>
      <time_frame>Baseline to 12 months</time_frame>
      <description>Will be assessed by simple percentage, based on scores from an Institute for Healthcare Improvement 10-point Likert scale (0-10, &quot;Would you recommend this program to your friends and family?&quot; A score ≥7 indicates high individual satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient attendance and feasibility</measure>
      <time_frame>Baseline to 12 months</time_frame>
      <description>Will be assessed by simple percentage. Attendance and feasibility will be determined by the number of patients attending ≥3 sessions out of five.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>At baseline, 1, 3, 6, and 12 months</time_frame>
      <description>Will examine predicted reductions in anxiety symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Anxiety will be measured using General Anxiety Disorder-7 (GAD-7) symptom scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>At baseline, 1, 3, 6, and 12 months</time_frame>
      <description>Will examine predicted reductions in depression symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Level of depression will be determined using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-8 (no suicidality item, item # 9) will be administered in research surveys in order to reduce need for clinical monitoring personnel. Note that all patients will have a suicidality assessment by a licensed mental health provider when care is initiated as standard of care as part of their evaluation in the Behavioral Medicine Program, and treatment will be recommended for all patients who meet clinical criteria for depression and/or suicidality. Follow-up care is continually available for all participants.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Hematopoietic and Lymphoid System Neoplasm</condition>
    <condition>Malignant Solid Neoplasm</condition>
    <arm_group>
      <arm_group_label>Group I (CBCSM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II (no CBCSM)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients complete questionnaires throughout the trial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Behavior Therapy</intervention_name>
      <description>Participate in CBCSM group sessions</description>
      <arm_group_label>Group I (CBCSM)</arm_group_label>
      <other_name>CBT</other_name>
      <other_name>cognitive therapy</other_name>
      <other_name>CT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Complete questionnaires</description>
      <arm_group_label>Group I (CBCSM)</arm_group_label>
      <arm_group_label>Group II (no CBCSM)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eligible for the cognitive behavioral cancer stress management (CBCSM) clinical&#xD;
               service&#xD;
  &#xD;
            -  Cancer diagnosis with predicted survival &gt; 1 year&#xD;
  &#xD;
            -  Cancer treatment within past 1 year or treatment planning in progress&#xD;
  &#xD;
            -  Age &gt;= 18-years&#xD;
  &#xD;
            -  Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score &gt;=&#xD;
               14 or clinical judgment&#xD;
  &#xD;
            -  Written informed research consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to actively participate in and learn from group therapy (e.g., psychotic&#xD;
               symptoms, neurological condition, personality pathology) as determined by clinical&#xD;
               judgment in clinical consultation (Individual therapy or alternative group therapy&#xD;
               will be offered)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shawna L. Ehlers, Ph.D., L.P.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic in Rochester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-776-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Deanna Hofschulte</last_name>
      <phone>507-255-2972</phone>
      <email>Hofschulte.Deanna@mayo.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mayo Clinic in Rochester</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Deanna Hofschulte</last_name>
        <phone>507-255-2972</phone>
        <email>Hofschulte.Deanna@mayo.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Shawna L. Ehlers, Ph.D., L.P.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Shawna L. Ehlers, Ph.D., L.P.</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015932
  org study id: 17-000947
  secondary id: NCI-2023-00250
  secondary id: 17-000947
  nct id: NCT06015932
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial tests how well cognitive behavioral cancer stress management (CBCSM)
        group sessions work to decrease psychological distress in cancer patients. CBCSM teaches
        patients how to recognize and reduce the impacts of cancer associated stress on the
        biological, psychological, and social life domains.
  PRIMARY OBJECTIVE:
  
        I. To reduce psychological stress.
  
        SECONDARY OBJECTIVES:
  
        I. To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in
        utilizing therapy skills. III. To estimate patient acceptability and feasibility of
        conducting CBCSM within the clinical setting.
  
        OUTLINE: Patients are assigned to 1 of 2 groups.
  
        GROUP I: Patients participate in five CBCSM group sessions on study. Patients complete
        questionnaires throughout the trial.
  
        GROUP II: Patients complete questionnaires throughout the trial.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in post-traumatic stress (PTS) score
  time frame: At baseline, 1, 3, 6, and 12 months
  description: Utilizing linear regression, intervention group membership (cognitive behavioral cancer stress management [Cognitive Behavioral Cancer Stress Management (CBCSM)] cases vs. control group) will be entered as the independent variable. PTS-change scores (post-intervention score - pre-intervention score) will be entered as the dependent variable. Covariates significantly associated with PTS score in univariate analyses and baseline PTS will be entered into the regression equation. P-values < .05 are significant.
  measure: Change in post-traumatic growth (PTG) score
  time frame: At baseline, 1, 3, 6, and 12 months
  description: Will examine predicted reductions in PTG associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be measured using the Patient-Reported Outcomes Measurement System (PROMIS®)-Psychosocial Impact Scale-Positive .
  measure: Change in self-efficacy score
  time frame: At baseline, 1, 3, 6, and 12 months
  description: Will examine predicted increase in self-efficacy associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be assessed using the Measure of Current Status-Part A (MOCS-A).
  measure: Patient acceptability and satisfaction
  time frame: Baseline to 12 months
  description: Will be assessed by simple percentage, based on scores from an Institute for Healthcare Improvement 10-point Likert scale (0-10, "Would you recommend this program to your friends and family?" A score ≥7 indicates high individual satisfaction.
  measure: Patient attendance and feasibility
  time frame: Baseline to 12 months
  description: Will be assessed by simple percentage. Attendance and feasibility will be determined by the number of patients attending ≥3 sessions out of five.
  measure: Anxiety
  time frame: At baseline, 1, 3, 6, and 12 months
  description: Will examine predicted reductions in anxiety symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Anxiety will be measured using General Anxiety Disorder-7 (GAD-7) symptom scores.
  measure: Depression
  time frame: At baseline, 1, 3, 6, and 12 months
  description: Will examine predicted reductions in depression symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Level of depression will be determined using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-8 (no suicidality item, item # 9) will be administered in research surveys in order to reduce need for clinical monitoring personnel. Note that all patients will have a suicidality assessment by a licensed mental health provider when care is initiated as standard of care as part of their evaluation in the Behavioral Medicine Program, and treatment will be recommended for all patients who meet clinical criteria for depression and/or suicidality. Follow-up care is continually available for all participants.
  arm group label: Group I (CBCSM)
  arm group type: Experimental
  description: Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial.
  arm group label: Group II (no CBCSM)
  arm group type: Active Comparator
  description: Patients complete questionnaires throughout the trial.
  intervention type: Behavioral
  intervention name: Cognitive Behavior Therapy
  description: Participate in CBCSM group sessions
  arm group label: Group I (CBCSM)
  other name: CBT
  other name: cognitive therapy
  other name: CT
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Complete questionnaires
  arm group label: Group I (CBCSM)
  arm group label: Group II (no CBCSM)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shawna L. Ehlers, Ph.D., L.P.
  role: Principal Investigator
  affiliation: Mayo Clinic in Rochester
  last name: Clinical Trials Referral Office
  phone: 855-776-0015
  email: mayocliniccancerstudies@mayo.edu
  last name: Deanna Hofschulte
  phone: 507-255-2972
  email: Hofschulte.Deanna@mayo.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Shawna L. Ehlers, Ph.D., L.P.
  investigator title: Principal Investigator
  mesh term: Neoplasms