<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/NCT03002896</url>
  </required_header>
  <id_info>
    <org_study_id>16-0990</org_study_id>
    <nct_id>NCT03002896</nct_id>
  </id_info>
  <brief_title>Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness</brief_title>
  <official_title>A Pilot Study of a Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based&#xD;
      Intervention) versus a treatment as usual control group. A total of 60 caregivers; including&#xD;
      caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers&#xD;
      enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage&#xD;
      III, solid tumor) will be enrolled in this study. The investigators do not expect different&#xD;
      outcomes from these three groups, rather these populations are selected to optimize&#xD;
      recruitment within a short time frame. The caregivers will be randomized to either treatment&#xD;
      as usual or Pep-Pal intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual&#xD;
      control group. A total of 60 caregivers; caregivers of patients with HSCT, caregivers of&#xD;
      patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer&#xD;
      (Stage IV, solid tumor) will be enrolled in this study. The investigators do not expect&#xD;
      different outcomes from these three groups, rather these populations are selected to optimize&#xD;
      recruitment within a short time frame. The caregivers will be randomized to either treatment&#xD;
      as usual or Pep-Pal intervention. The proposed study population is based on prior research&#xD;
      indicating that caregivers of patients receiving HSCT, caregivers of patients enrolled in&#xD;
      phase I oncology trials, and caregivers of patients with advanced cancer experience&#xD;
      significant distress. In addition, an initial study of caregivers of patients receiving&#xD;
      allogeneic-HSCT were able to benefit from a brief, cognitive behavioral stress management&#xD;
      treatment approach. A study examining distress in phase I oncology clinical trial patient&#xD;
      caregivers highlighted the need for more support for this significantly distressed&#xD;
      population. Furthermore, initial results of the qualitative development study for Pep-Pal&#xD;
      yielded support for a mobilized platform delivery of resources for caregivers to manage&#xD;
      distress because they acknowledged many barriers to engaging in in-person treatment to manage&#xD;
      distress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 13, 2018</completion_date>
  <primary_completion_date type="Actual">November 17, 2017</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 (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Exit Interviews</measure>
    <time_frame>12 weeks</time_frame>
    <description>Qualitative feedback will be gathered from the first 15 Pep-Pal completer's for individual interviews (5 from Phase I group, 5 from Hematopoietic stem cell transplantation (HSCT) group, 5 from medical oncology) upon completion of the follow-up assessments at 12 weeks about usage, acceptability of content, and impressions of using Pep-Pal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pep-Pal Self-Report sessions at 12 Weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Investigators will assess feasibility by examining recruitment, retention, as well as reasons for refusal, frequency of sessions watched and length of time spent watching each session. Self report usage of peppal: Usage of Pep-Pal will be quantitatively assessed by asking each participant in the intervention group about their usage including frequency; how many times they watched each session and length of viewing for each session (partial or complete). They will be asked to rate level of usage based on a Likert-scale ranging from not at all to very often for each session (0-10). They will be asked to rank order the list of sessions from most helpful to least helpful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Self-Report Caregiver reported outcomes at Baseline</measure>
    <time_frame>Week 1</time_frame>
    <description>Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at 12 weeks</measure>
    <time_frame>Week 12</time_frame>
    <description>Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at baseline</measure>
    <time_frame>Week 1</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CESD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at baseline</measure>
    <time_frame>Week 1</time_frame>
    <description>Perceived Stress Scale (PSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at baseline</measure>
    <time_frame>Week 1</time_frame>
    <description>Female Sexual Function Index (FSFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at baseline</measure>
    <time_frame>Week 1</time_frame>
    <description>Male Sexual Health Questionnaire(MSHQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at baseline</measure>
    <time_frame>Week 1</time_frame>
    <description>Measure of Current Status (MOCS-A)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at 12 weeks</measure>
    <time_frame>Week 12</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CESD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at 12 weeks</measure>
    <time_frame>Week 12</time_frame>
    <description>Perceived Stress Scale (PSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at 12 weeks</measure>
    <time_frame>Week 12</time_frame>
    <description>Female Sexual Function Index (FSFI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at 12 weeks</measure>
    <time_frame>Week 12</time_frame>
    <description>Male Sexual Health Questionnaire(MSHQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Self-report caregiver reported outcomes at 12 weeks</measure>
    <time_frame>Week 12</time_frame>
    <description>Measure of Current Status (MOCS-A)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Distress</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Pep-Pal + Treatment as Usual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the caregiver is assigned to the Pep-Pal intervention condition, the RA will provide access to the mobilized website (passcode) through an email. Caregivers will be instructed to watch each session at least once. It will be recommended that caregivers watch one to two new sessions per week so that they can have enough time to practice the skills between sessions. In addition, they will be told that they can go back and watch the sessions for review as many times as they like. Full participation will be defined as watching at least 7/9 sessions (75% of program) based on previous criteria for similar intervention completion in a prior trial with advanced cancer patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pep-Pal</intervention_name>
    <description>Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained. In this way, Pep-Pal is a resource for our most hard to reach caregivers.</description>
    <arm_group_label>Pep-Pal + Treatment as Usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <arm_group_label>Pep-Pal + Treatment as Usual</arm_group_label>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women and men ≥ 18 years of age of any ethnicity&#xD;
&#xD;
          2. Must endorse a moderate level of anxiety (e.g. Score above an 8 on the Hospital and&#xD;
             Anxiety Depression Scale (HADS))&#xD;
&#xD;
          3. Speak and read in English&#xD;
&#xD;
          4. Caregiver of a patient with auto HSCT who are moving forward with bone marrow&#xD;
             transplant or have receive a bone marrow transplant&#xD;
&#xD;
          5. Caregiver of a patient in a Phase I Clinical Trial&#xD;
&#xD;
          6. Caregiver of a patient diagnosed with advanced cancer (stage III or stage IV)&#xD;
&#xD;
          7. No Cognitive or psychiatric conditions prohibiting participation&#xD;
&#xD;
          8. Must meet criteria for being a primary caregiver, defined as, the person in the&#xD;
             patient's life who is primarily responsible for care decisions, emotionally invested&#xD;
             in the patient's care, provides instrumental care such as transportation for a patient&#xD;
             receiving auto-HSCT, enrolled in a phase I oncology clinical trial, or of a patient&#xD;
             diagnosed with advanced cancer (stage IV, solid tumor).&#xD;
&#xD;
          9. Have a computer, smartphone, or tablet with internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Caregivers below the age of 18&#xD;
&#xD;
          2. Score below an 8 on the Hospital and Anxiety Depression Scale (HADS)&#xD;
&#xD;
          3. Cannot speak and read in English&#xD;
&#xD;
          4. Patient does not receive a bone marrow transplant&#xD;
&#xD;
          5. Patient is not enrolled in a Phase I clinical trial&#xD;
&#xD;
          6. Patient is not diagnosed with Stage III or Stage IV cancer&#xD;
&#xD;
          7. Cognitive conditions prohibiting participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole R Amoyal-Pensak, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado, Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Pep-pal</keyword>
  <keyword>Pep-Pal + Treatment as Usual</keyword>
  <keyword>Treatment as Usual</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <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/NCT03002896
org study id: 16-0990
nct id: NCT03002896
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed project is a pilot study of the Pep-Pal (Psychoeducation and Skills Based
      Intervention) versus a treatment as usual control group. A total of 60 caregivers; including
      caregivers of patients with HSCT (Hematopoietic Stem Cell Transplantation), caregivers
      enrolled in Phase I clinical trials, and caregivers of patients with advanced cancer (Stage
      III, solid tumor) will be enrolled in this study. The investigators do not expect different
      outcomes from these three groups, rather these populations are selected to optimize
      recruitment within a short time frame. The caregivers will be randomized to either treatment
      as usual or Pep-Pal intervention.
The proposed project is a pilot study of the Pep-Pal intervention versus a treatment as usual
      control group. A total of 60 caregivers; caregivers of patients with HSCT, caregivers of
      patients enrolled in phase I oncology trials, and caregivers of patients with advanced cancer
      (Stage IV, solid tumor) will be enrolled in this study. The investigators do not expect
      different outcomes from these three groups, rather these populations are selected to optimize
      recruitment within a short time frame. The caregivers will be randomized to either treatment
      as usual or Pep-Pal intervention. The proposed study population is based on prior research
      indicating that caregivers of patients receiving HSCT, caregivers of patients enrolled in
      phase I oncology trials, and caregivers of patients with advanced cancer experience
      significant distress. In addition, an initial study of caregivers of patients receiving
      allogeneic-HSCT were able to benefit from a brief, cognitive behavioral stress management
      treatment approach. A study examining distress in phase I oncology clinical trial patient
      caregivers highlighted the need for more support for this significantly distressed
      population. Furthermore, initial results of the qualitative development study for Pep-Pal
      yielded support for a mobilized platform delivery of resources for caregivers to manage
      distress because they acknowledged many barriers to engaging in in-person treatment to manage
      distress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Care Provider)
measure: Evaluation of Exit Interviews
time frame: 12 weeks
description: Qualitative feedback will be gathered from the first 15 Pep-Pal completer's for individual interviews (5 from Phase I group, 5 from Hematopoietic stem cell transplantation (HSCT) group, 5 from medical oncology) upon completion of the follow-up assessments at 12 weeks about usage, acceptability of content, and impressions of using Pep-Pal.
measure: Pep-Pal Self-Report sessions at 12 Weeks
time frame: 12 weeks
description: The Investigators will assess feasibility by examining recruitment, retention, as well as reasons for refusal, frequency of sessions watched and length of time spent watching each session. Self report usage of peppal: Usage of Pep-Pal will be quantitatively assessed by asking each participant in the intervention group about their usage including frequency; how many times they watched each session and length of viewing for each session (partial or complete). They will be asked to rate level of usage based on a Likert-scale ranging from not at all to very often for each session (0-10). They will be asked to rank order the list of sessions from most helpful to least helpful.
measure: Evaluation of Self-Report Caregiver reported outcomes at Baseline
time frame: Week 1
description: Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
time frame: Week 12
description: Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A)
measure: Evaluation of Self-report caregiver reported outcomes at baseline
time frame: Week 1
description: Center for Epidemiologic Studies Depression Scale (CESD)
measure: Evaluation of Self-report caregiver reported outcomes at baseline
time frame: Week 1
description: Perceived Stress Scale (PSS)
measure: Evaluation of Self-report caregiver reported outcomes at baseline
time frame: Week 1
description: Female Sexual Function Index (FSFI)
measure: Evaluation of Self-report caregiver reported outcomes at baseline
time frame: Week 1
description: Male Sexual Health Questionnaire(MSHQ)
measure: Evaluation of Self-report caregiver reported outcomes at baseline
time frame: Week 1
description: Measure of Current Status (MOCS-A)
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
time frame: Week 12
description: Center for Epidemiologic Studies Depression Scale (CESD)
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
time frame: Week 12
description: Perceived Stress Scale (PSS)
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
time frame: Week 12
description: Female Sexual Function Index (FSFI)
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
time frame: Week 12
description: Male Sexual Health Questionnaire(MSHQ)
measure: Evaluation of Self-report caregiver reported outcomes at 12 weeks
time frame: Week 12
description: Measure of Current Status (MOCS-A)
arm group label: Pep-Pal + Treatment as Usual
arm group type: Experimental
description: If the caregiver is assigned to the Pep-Pal intervention condition, the RA will provide access to the mobilized website (passcode) through an email. Caregivers will be instructed to watch each session at least once. It will be recommended that caregivers watch one to two new sessions per week so that they can have enough time to practice the skills between sessions. In addition, they will be told that they can go back and watch the sessions for review as many times as they like. Full participation will be defined as watching at least 7/9 sessions (75% of program) based on previous criteria for similar intervention completion in a prior trial with advanced cancer patients.
arm group label: Treatment as Usual
arm group type: Active Comparator
description: Treatment as usual provides voluntary (at the caregiver's discretion) support services for the caregivers which is rarely used by the caregivers.
intervention type: Behavioral
intervention name: Pep-Pal
description: Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained. In this way, Pep-Pal is a resource for our most hard to reach caregivers.
arm group label: Pep-Pal + Treatment as Usual
intervention type: Other
intervention name: Treatment as Usual
arm group label: Pep-Pal + Treatment as Usual
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nicole R Amoyal-Pensak, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
sharing ipd: No