<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/NCT03804164</url>
  </required_header>
  <id_info>
    <org_study_id>18442</org_study_id>
    <secondary_id>NCI-2018-03851</secondary_id>
    <secondary_id>18442</secondary_id>
    <nct_id>NCT03804164</nct_id>
  </id_info>
  <brief_title>Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer</brief_title>
  <official_title>A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot trial studies how well a psycho-educational program called Emerging from the Haze&#xD;
      works in helping patients with blood and lymph cancer. Sometimes, patients who have undergone&#xD;
      treatment for cancer experience thinking or memory problems that make work, school, or&#xD;
      everyday life activities, such as grocery shopping, difficult. The Emerging from the Haze&#xD;
      program may provide resources to help deal with these types of challenges in patients with&#xD;
      blood and lymph cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Demonstrate feasibility and acceptability for young adult survivors of various cancers&#xD;
      utilizing Emerging from the Haze program.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Describe, summarize study population. II. Characterize, compare the measure scores at&#xD;
      pre-intervention assessment to the measure scores at post-intervention assessment.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients participate in the Emerging from the Haze psycho-educational program weekly over 2&#xD;
      hours for 6 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Feasibility&#xD;
  </why_stopped>
  <start_date type="Actual">February 10, 2020</start_date>
  <completion_date type="Actual">February 10, 2020</completion_date>
  <primary_completion_date type="Actual">February 10, 2020</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enrollment of eligible participants (accrual)</measure>
    <time_frame>Up to 30 days post the end of the six-week program</time_frame>
    <description>Feasibility will be assessed through enrollment of &gt;= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for &gt;= 80% of participants (adherence/engagement).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completion of sessions (adherence/engagement)</measure>
    <time_frame>Up to 30 days post the end of the six-week program</time_frame>
    <description>Feasibility will be assessed through enrollment of &gt;= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for &gt;= 80% of participants (adherence/engagement).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Assessment of Cancer Therapy-Cognition scores</measure>
    <time_frame>Baseline up to 30 days post the end of the six-week program</time_frame>
    <description>Functional Assessment of Cancer Therapy-Cognitive Function (version 3) (assesses cognitive functioning) The four subscales and associated ranges are as follows: Perceived Cognitive Impairments (range 0-72), Impact of Perceived Cognitive Impairments on Quality of Life (range 0-16), Comments from Others (range 0-16) and Perceived Cognitive Abilities (range 0-28).&#xD;
The higher the score, the better the outcome. There is no total score on this measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores</measure>
    <time_frame>Baseline up to 30 days post the end of the six-week program</time_frame>
    <description>Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.&#xD;
Patient Reported Outcomes Measurement Information System: Cognitive Function- General Concerns version 1.0 and Cognitive Function-Abilities version 1.0 subscales (assess cognitive functioning).For each of these scales the raw score range is 8-40. These scores are then converted to T-scores (Mean = 50, SD = 10).For each of these scales the raw score range is 8-40. These scores are then converted to T-scores (Mean = 50, SD = 10).&#xD;
Subscales are not combined for these scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Global Self-Report of Cognition scores</measure>
    <time_frame>Baseline up to 30 days post the end of the six-week program</time_frame>
    <description>Will use two additional questions in an attempt to capture patient's perception of pre-treatment and current cognitive function and memory. These questions will be scored on a Likert scale (0= best memory possible, 10= worst memory possible) and will be provided to patients at the first and last session. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS-29 items (29) scores</measure>
    <time_frame>Baseline up to 30 days post the end of the six-week program</time_frame>
    <description>Each domain is scored separately. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.&#xD;
Patient Reported Outcomes Measurement Information System-29 version 2.0 (assesses symptoms of depression, anxiety, physical function, pain interference, pain intensity, fatigue, sleep disturbance, and ability to participate in social and activities.&#xD;
Raw scores range from 4-20 for each subscale listed above except pain intensity which is a single item ranging from 0-10. The raw scores are then converted into T-scores (Mean = 50, SD = 10).&#xD;
For physical function, two sleep items and social activities subscales a higher T-score represents higher functioning. For anxiety, depression, fatigue, the other two sleep items and pain interference a higher T-score represents worse functioning.&#xD;
The subscales are not combined on this measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Survey scores</measure>
    <time_frame>Up to 30 days post the end of the six-week program</time_frame>
    <description>Will use a survey to assess satisfaction with the class content and delivery. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.&#xD;
Emerging From the Haze Course Survey (assesses satisfaction with the course and content).&#xD;
Total scores from responses range from 0-56. Higher values represent more satisfaction with the program. The scores are not combined for this survey.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hematopoietic and Lymphoid Cell Neoplasm</condition>
  <arm_group>
    <arm_group_label>Supportive Care (psycho-educational sessions)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Attend Emerging from the Haze psychoeducational sessions</description>
    <arm_group_label>Supportive Care (psycho-educational sessions)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (psycho-educational sessions)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (psycho-educational sessions)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of a hematological malignancy.&#xD;
&#xD;
          -  Having received chemotherapy with or without radiation therapy.&#xD;
&#xD;
          -  Physician approval.&#xD;
&#xD;
          -  Functional Assessment of Cancer Therapy-Cognition (FACT-COG) score &lt; 59 on the&#xD;
             perceived cognitive impairments (PCI) subscale.&#xD;
&#xD;
          -  Eligible after 2 months (60 +/- 5 days) of completing all their active cancer&#xD;
             treatment with the exception of patients that are post-transplant.&#xD;
&#xD;
          -  Subjective complaint of cognitive concerns at time of enrollment.&#xD;
&#xD;
          -  Must be able to understand and communicate proficiently in English.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
          -  Agree to complete study surveys.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have significant personality disorders or unstable psychiatric disorders&#xD;
             as assessed by the interviewing clinician.&#xD;
&#xD;
          -  Patients with known brain metastases, history of brain metastases or radiation to the&#xD;
             brain.&#xD;
&#xD;
          -  Patients with a history of stroke or other pre-existing neurological condition that&#xD;
             may contribute to cognitive dysfunction.&#xD;
&#xD;
          -  Non-English speaking patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natalie Kelly, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</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/NCT03804164
org study id: 18442
secondary id: NCI-2018-03851
secondary id: 18442
nct id: NCT03804164
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This pilot trial studies how well a psycho-educational program called Emerging from the Haze
      works in helping patients with blood and lymph cancer. Sometimes, patients who have undergone
      treatment for cancer experience thinking or memory problems that make work, school, or
      everyday life activities, such as grocery shopping, difficult. The Emerging from the Haze
      program may provide resources to help deal with these types of challenges in patients with
      blood and lymph cancer.
PRIMARY OBJECTIVES:

      I. Demonstrate feasibility and acceptability for young adult survivors of various cancers
      utilizing Emerging from the Haze program.

      SECONDARY OBJECTIVES:

      I. Describe, summarize study population. II. Characterize, compare the measure scores at
      pre-intervention assessment to the measure scores at post-intervention assessment.

      OUTLINE:

      Patients participate in the Emerging from the Haze psycho-educational program weekly over 2
      hours for 6 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Enrollment of eligible participants (accrual)
time frame: Up to 30 days post the end of the six-week program
description: Feasibility will be assessed through enrollment of >= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for >= 80% of participants (adherence/engagement).
measure: Completion of sessions (adherence/engagement)
time frame: Up to 30 days post the end of the six-week program
description: Feasibility will be assessed through enrollment of >= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for >= 80% of participants (adherence/engagement).
measure: Change in Functional Assessment of Cancer Therapy-Cognition scores
time frame: Baseline up to 30 days post the end of the six-week program
description: Functional Assessment of Cancer Therapy-Cognitive Function (version 3) (assesses cognitive functioning) The four subscales and associated ranges are as follows: Perceived Cognitive Impairments (range 0-72), Impact of Perceived Cognitive Impairments on Quality of Life (range 0-16), Comments from Others (range 0-16) and Perceived Cognitive Abilities (range 0-28).
The higher the score, the better the outcome. There is no total score on this measure.
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores
time frame: Baseline up to 30 days post the end of the six-week program
description: Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.
Patient Reported Outcomes Measurement Information System: Cognitive Function- General Concerns version 1.0 and Cognitive Function-Abilities version 1.0 subscales (assess cognitive functioning).For each of these scales the raw score range is 8-40. These scores are then converted to T-scores (Mean = 50, SD = 10).For each of these scales the raw score range is 8-40. These scores are then converted to T-scores (Mean = 50, SD = 10).
Subscales are not combined for these scales
measure: Change in Global Self-Report of Cognition scores
time frame: Baseline up to 30 days post the end of the six-week program
description: Will use two additional questions in an attempt to capture patient's perception of pre-treatment and current cognitive function and memory. These questions will be scored on a Likert scale (0= best memory possible, 10= worst memory possible) and will be provided to patients at the first and last session. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Change in PROMIS-29 items (29) scores
time frame: Baseline up to 30 days post the end of the six-week program
description: Each domain is scored separately. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.
Patient Reported Outcomes Measurement Information System-29 version 2.0 (assesses symptoms of depression, anxiety, physical function, pain interference, pain intensity, fatigue, sleep disturbance, and ability to participate in social and activities.
Raw scores range from 4-20 for each subscale listed above except pain intensity which is a single item ranging from 0-10. The raw scores are then converted into T-scores (Mean = 50, SD = 10).
For physical function, two sleep items and social activities subscales a higher T-score represents higher functioning. For anxiety, depression, fatigue, the other two sleep items and pain interference a higher T-score represents worse functioning.
The subscales are not combined on this measure
measure: Satisfaction Survey scores
time frame: Up to 30 days post the end of the six-week program
description: Will use a survey to assess satisfaction with the class content and delivery. Will be used to characterize the change of the study population and evaluate patterns suggesting potential intervention efficacy on outcomes.
Emerging From the Haze Course Survey (assesses satisfaction with the course and content).
Total scores from responses range from 0-56. Higher values represent more satisfaction with the program. The scores are not combined for this survey.
arm group label: Supportive Care (psycho-educational sessions)
arm group type: Experimental
description: Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
intervention type: Other
intervention name: Educational Intervention
description: Attend Emerging from the Haze psychoeducational sessions
arm group label: Supportive Care (psycho-educational sessions)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive Care (psycho-educational sessions)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Supportive Care (psycho-educational sessions)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Natalie Kelly, PhD
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hematologic Neoplasms