<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/NCT01709344</url>
  </required_header>
  <id_info>
    <org_study_id>D12110</org_study_id>
    <nct_id>NCT01709344</nct_id>
  </id_info>
  <brief_title>Reducing Disability in Older Adult Cancer Survivors</brief_title>
  <official_title>A Phase I Randomized Controlled Trial of a Problem-solving Occupational Therapy Intervention for Older Adult Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Older adults who are treated for cancer are at risk of developing disabilities due to the&#xD;
      symptoms of cancer and the side effects of treatment. Disability occurs when a person has&#xD;
      trouble performing the activities he or she needs to do in everyday life. For example,&#xD;
      fatigue and pain can make it difficult for an older adult to do housework, leisure, or&#xD;
      volunteer activities. Disability makes it harder for older adults to stay active and be&#xD;
      productive members of the community, and it can increase the costs of healthcare.&#xD;
&#xD;
      Current approaches to cancer rehabilitation focus on using exercise, education, and social&#xD;
      support to reduce cancer treatment side effects. These are important strategies to reduce&#xD;
      disability, yet some side effects persist despite best efforts to resolve them. To fully&#xD;
      reduce disability, people often need to adapt their activities or the environments in which&#xD;
      they are performed.&#xD;
&#xD;
      The goal of this study is to test an occupational therapy (OT) intervention that teaches&#xD;
      activity planning skills to foster survivors' ability to adapt activities, routines, and&#xD;
      environments in order to minimize disability. The project targets adults over the age of 65&#xD;
      who are experiencing disability during or after cancer treatment. The project has two stages.&#xD;
      First, twelve older adult cancer survivors will individually participate in the&#xD;
      community-based intervention. After they have completed the program the investigators will&#xD;
      revise the intervention to emphasize what they found most effective and helpful, and to&#xD;
      eliminate aspects of the intervention that are perceived as unhelpful or redundant. The&#xD;
      research question for this first stage of the project is, &quot;To what degree is it feasible for&#xD;
      survivors to enroll in the study, complete the six-week intervention, and complete the three&#xD;
      outcome assessments?&quot; In the second stage of the project, the investigators will test the&#xD;
      revised intervention, comparing it to conventional care. The research question for the second&#xD;
      stage of the project is, &quot;Do the people receiving the intervention have higher activity&#xD;
      levels, greater behavioral activation, lower levels of disability, and better quality of life&#xD;
      compared to those people who receive traditional cancer care?&quot; The intervention is&#xD;
      appropriate for people who have been diagnosed with any type of cancer. It is designed to&#xD;
      focus on whatever activities are most important to each participant. The novelty of the&#xD;
      proposed intervention lies in the combination of the OT strategies of activity and&#xD;
      environmental adaptation with explicit training in activity planning to teach survivors to&#xD;
      find creative ways to engage in valued activities (e.g., taking care of one's home and family&#xD;
      members, and participating in leisure, community, social and work activities). If the&#xD;
      intervention is effective in reducing disability, it will give us another tool to reduce the&#xD;
      impact of cancer on the daily lives of cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Disability</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Late-Life Function and Disability Instrument</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Functional Assessment of Cancer Therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity level</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Activity Card Sort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral activation</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Behavioral activation scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Patient Health Questionnaire-9 (PHQ-9)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>PS-OT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Problem-solving Occupational Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Access to all supportive and rehabilitative services available at DHMC</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PS-OT</intervention_name>
    <arm_group_label>PS-OT</arm_group_label>
    <other_name>Problem-solving Occupational Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Supportive and rehabilitation services available at DHMC</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Age 65 years or older.&#xD;
&#xD;
          2. Experiencing disability as indicated by a score of &gt; 3 on the Vulnerable Elders Survey&#xD;
             or an answer of &quot;yes&quot; to the question &quot;Do health problems interfere with your ability&#xD;
             to carry out your social or day to day activities?&quot;&#xD;
&#xD;
          3. Either: a. Diagnosed with any solid or hematological cancer, undergoing treatment for&#xD;
             curative intent or within six months of completion of therapy with absence of disease&#xD;
             recurrence; or b.Diagnosed with metastatic breast cancer or chronic hematologic&#xD;
             malignancies with a life expectancy of &gt; 2 years&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Moderate or worse cognitive impairment as indicated by a score of 3 or less on the&#xD;
             Callahan six-item cognitive screening tool.&#xD;
&#xD;
          2. Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar&#xD;
             disorder), active suicidal ideation, or active substance use disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>March 16, 2018</last_update_submitted>
  <last_update_submitted_qc>March 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Kathleen Lyons</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01709344
org study id: D12110
nct id: NCT01709344
lead sponsor: 
collaborator: 
has dmc: Yes
Older adults who are treated for cancer are at risk of developing disabilities due to the
      symptoms of cancer and the side effects of treatment. Disability occurs when a person has
      trouble performing the activities he or she needs to do in everyday life. For example,
      fatigue and pain can make it difficult for an older adult to do housework, leisure, or
      volunteer activities. Disability makes it harder for older adults to stay active and be
      productive members of the community, and it can increase the costs of healthcare.

      Current approaches to cancer rehabilitation focus on using exercise, education, and social
      support to reduce cancer treatment side effects. These are important strategies to reduce
      disability, yet some side effects persist despite best efforts to resolve them. To fully
      reduce disability, people often need to adapt their activities or the environments in which
      they are performed.

      The goal of this study is to test an occupational therapy (OT) intervention that teaches
      activity planning skills to foster survivors' ability to adapt activities, routines, and
      environments in order to minimize disability. The project targets adults over the age of 65
      who are experiencing disability during or after cancer treatment. The project has two stages.
      First, twelve older adult cancer survivors will individually participate in the
      community-based intervention. After they have completed the program the investigators will
      revise the intervention to emphasize what they found most effective and helpful, and to
      eliminate aspects of the intervention that are perceived as unhelpful or redundant. The
      research question for this first stage of the project is, "To what degree is it feasible for
      survivors to enroll in the study, complete the six-week intervention, and complete the three
      outcome assessments?" In the second stage of the project, the investigators will test the
      revised intervention, comparing it to conventional care. The research question for the second
      stage of the project is, "Do the people receiving the intervention have higher activity
      levels, greater behavioral activation, lower levels of disability, and better quality of life
      compared to those people who receive traditional cancer care?" The intervention is
      appropriate for people who have been diagnosed with any type of cancer. It is designed to
      focus on whatever activities are most important to each participant. The novelty of the
      proposed intervention lies in the combination of the OT strategies of activity and
      environmental adaptation with explicit training in activity planning to teach survivors to
      find creative ways to engage in valued activities (e.g., taking care of one's home and family
      members, and participating in leisure, community, social and work activities). If the
      intervention is effective in reducing disability, it will give us another tool to reduce the
      impact of cancer on the daily lives of cancer survivors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Disability
time frame: Eight weeks
description: Late-Life Function and Disability Instrument
measure: Quality of Life
time frame: Eight weeks
description: Functional Assessment of Cancer Therapy
measure: Activity level
time frame: Eight weeks
description: Activity Card Sort
measure: Behavioral activation
time frame: Eight weeks
description: Behavioral activation scale
measure: Depression
time frame: Eight weeks
description: Patient Health Questionnaire-9 (PHQ-9)
arm group label: PS-OT
arm group type: Experimental
description: Problem-solving Occupational Therapy
arm group label: Usual care
arm group type: Other
description: Access to all supportive and rehabilitative services available at DHMC
intervention type: Behavioral
intervention name: PS-OT
arm group label: PS-OT
other name: Problem-solving Occupational Therapy
intervention type: Other
intervention name: Usual care
description: Supportive and rehabilitation services available at DHMC
arm group label: Usual care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Kathleen Lyons
investigator title: Research Assistant Professor