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/NCT05984589</url>
    </required_header>
    <id_info>
      <org_study_id>IIT2023-04-SLEIGHT-RISE-PSMT</org_study_id>
      <secondary_id>1K01HD110719-01A1</secondary_id>
      <nct_id>NCT05984589</nct_id>
    </id_info>
    <brief_title>Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.</brief_title>
    <official_title>IIT2023-04-SLEIGHT-RISE-PSMT: A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Colorectal Cancer (CRC) Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alix G. Sleight, PhD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Cedars-Sinai 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase 2 prospective, randomized, controlled, double-arm study to assess&#xD;
        personalized self-management training (PSMT) intervention efficacy and patient experiences&#xD;
        compared to standardized self-management training (SSMT). A total of 120 colorectal cancer&#xD;
        (CRC) patients will be enrolled and randomized 1:1 to complete a 6-week self-management&#xD;
        training program (either PSMT or SSMT) to be carried out by licensed occupational therapists&#xD;
        with doctoral training.&#xD;
  &#xD;
        This study aims to examine whether PSMT is more effective in increasing adherence to healthy&#xD;
        behavior recommendations compared to SSMT in CRC patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 27, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 27, 2026</primary_completion_date>
    <phase>Phase 2</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.</measure>
      <time_frame>12 weeks.</time_frame>
      <description>Outcome measures contributing to each component of WCRF/AICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF/AICR scale comprises of 7 categories with each category given a score for non-/low adherence, moderate/some adherence, or full adherence to each HBR. Total value ranges from 0 to 7 points, with a higher score indicating better adherence. HBR items include body composition, physical activity, diet, and alcohol use.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The difference in general self-efficacy between the two groups after the 6-week self-management program will be measured by Patient-Reported Outcomes Measurement Systems (PROMIS) Item Bank v1.0 - General Self-Efficacy Short Form 4a.</measure>
      <time_frame>12 weeks.</time_frame>
      <description>Responses to this questionnaire will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up 6 Weeks Post-Session 6. The questionnaire asks the subject to rate their confidence levels in managing various situations, problems, and events. There are a total of 4 questions, and each question is answered on a scale of 1-4 where higher scores indicate the highest level of confidence. Total value ranges from 4 to 20, with a higher score indicating higher self-efficacy or highest level of confidence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the difference in health-related quality of life between the two groups after completion of the self-management program, we will use the PROMIS Scale v1.2 - Global Health questionnaire .</measure>
      <time_frame>12 weeks.</time_frame>
      <description>Responses will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks post Session 6).The questionnaire includes the following components to assess subject's rating on their global physical and mental health: 6 questions are each answered on a scale of 1-5 where higher scoores indicate excellent health, 1 question is answered on a scale of 1-5 where higher scores indicate being able to completely carry out everyday physical activities, and the last 3 questions are answered on a scale of 1-5 where higher scores indicate less frequency or no occurences of fatigue, pain, or emotional problems.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Healthy Lifestyle</condition>
    <condition>Behavior, Health</condition>
    <condition>Health Behavior</condition>
    <arm_group>
      <arm_group_label>RISE-PSMT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SSMT</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Standardized self-management training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>RISE Personalized Self-Managament Training (PSMT)</intervention_name>
      <description>Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create lasting change. The 6-week intervention includes 2 in-person visits and 4 videoconference sessions.</description>
      <arm_group_label>RISE-PSMT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standardized Self-Managament Training (SSMT)</intervention_name>
      <description>Participants randomized to the control condition will receive 6 standardized sessions from one of the OT interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research participation and increased knowledge about HBRs, and that simply providing standardized didactic content as an intervention modality without any personalization will have negligible effects on participants' healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for HB change.</description>
      <arm_group_label>SSMT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years at the time of consent.&#xD;
  &#xD;
            2. History of Stage I-III colorectal cancer (CRC) within the past 12 months prior to&#xD;
               enrollment.&#xD;
  &#xD;
            3. Ability to speak, write, and read English sufficiently to allow for program&#xD;
               participation.&#xD;
  &#xD;
            4. Identified by self-report as having willingness and interest to work on at least one&#xD;
               lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical&#xD;
               activity, body composition, alcohol use.&#xD;
  &#xD;
            5. Scoring ≤3.5 on the World Cancer Research Fund/American Institute for Cancer Research&#xD;
               (WCRF/AICR) Health Behavior Adherence Scale (Table 1) consistent with moderate to low&#xD;
               adherence to healthy behavior recommendations (HBRs).&#xD;
  &#xD;
            6. Written informed consent obtained from subject and ability for subject to comply with&#xD;
               the requirements of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Cognitive or mental impairments that in the opinion of the Principal Investigator or&#xD;
               study physician would hinder the program participation.&#xD;
  &#xD;
            2. Planning to have active anti-cancer treatment (including radiation, chemo, and/or&#xD;
               major surgery) within 6 months after initial interventional or control session.&#xD;
               Long-term hormonal/biologic therapy is acceptable.&#xD;
  &#xD;
            3. Known metastatic disease (Stage IV cancers).&#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>Alix G Sleight, PhD, OTD, MPH, OTR/L</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cedars-Sinai Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trial Recruitment Navigator</last_name>
      <phone>310-423-2133</phone>
      <email>cancer.trial.info@cshs.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cedars-Sinai Medical Center</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90048</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ana Martin, MD</last_name>
        <phone>310-423-8887</phone>
        <email>ana.martin@cshs.org</email>
      </contact>
      <investigator>
        <last_name>Andrew Hendifar, MD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jun Gong, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stephen Freedland, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pamela Roberts, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sarah Salvy, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Patricia Thompson, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Arash Asher, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Philip Chang, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>LJ Amaral, MS, RD, CSO</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
      <investigator_full_name>Alix G. Sleight, PhD</investigator_full_name>
      <investigator_title>Associate Professor, Department of Physical Medicine and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>self-management training</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal 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/NCT05984589
  org study id: IIT2023-04-SLEIGHT-RISE-PSMT
  secondary id: 1K01HD110719-01A1
  nct id: NCT05984589
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase 2 prospective, randomized, controlled, double-arm study to assess
        personalized self-management training (PSMT) intervention efficacy and patient experiences
        compared to standardized self-management training (SSMT). A total of 120 colorectal cancer
        (CRC) patients will be enrolled and randomized 1:1 to complete a 6-week self-management
        training program (either PSMT or SSMT) to be carried out by licensed occupational therapists
        with doctoral training.
  
        This study aims to examine whether PSMT is more effective in increasing adherence to healthy
        behavior recommendations compared to SSMT in CRC patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.
  time frame: 12 weeks.
  description: Outcome measures contributing to each component of WCRF/AICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF/AICR scale comprises of 7 categories with each category given a score for non-/low adherence, moderate/some adherence, or full adherence to each HBR. Total value ranges from 0 to 7 points, with a higher score indicating better adherence. HBR items include body composition, physical activity, diet, and alcohol use.
  measure: The difference in general self-efficacy between the two groups after the 6-week self-management program will be measured by Patient-Reported Outcomes Measurement Systems (PROMIS) Item Bank v1.0 - General Self-Efficacy Short Form 4a.
  time frame: 12 weeks.
  description: Responses to this questionnaire will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up 6 Weeks Post-Session 6. The questionnaire asks the subject to rate their confidence levels in managing various situations, problems, and events. There are a total of 4 questions, and each question is answered on a scale of 1-4 where higher scores indicate the highest level of confidence. Total value ranges from 4 to 20, with a higher score indicating higher self-efficacy or highest level of confidence.
  measure: To evaluate the difference in health-related quality of life between the two groups after completion of the self-management program, we will use the PROMIS Scale v1.2 - Global Health questionnaire .
  time frame: 12 weeks.
  description: Responses will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks post Session 6).The questionnaire includes the following components to assess subject's rating on their global physical and mental health: 6 questions are each answered on a scale of 1-5 where higher scoores indicate excellent health, 1 question is answered on a scale of 1-5 where higher scores indicate being able to completely carry out everyday physical activities, and the last 3 questions are answered on a scale of 1-5 where higher scores indicate less frequency or no occurences of fatigue, pain, or emotional problems.
  arm group label: RISE-PSMT
  arm group type: Experimental
  description: Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.
  arm group label: SSMT
  arm group type: Placebo Comparator
  description: Standardized self-management training.
  intervention type: Behavioral
  intervention name: RISE Personalized Self-Managament Training (PSMT)
  description: Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create lasting change. The 6-week intervention includes 2 in-person visits and 4 videoconference sessions.
  arm group label: RISE-PSMT
  intervention type: Behavioral
  intervention name: Standardized Self-Managament Training (SSMT)
  description: Participants randomized to the control condition will receive 6 standardized sessions from one of the OT interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research participation and increased knowledge about HBRs, and that simply providing standardized didactic content as an intervention modality without any personalization will have negligible effects on participants' healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for HB change.
  arm group label: SSMT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alix G Sleight, PhD, OTD, MPH, OTR/L
  role: Principal Investigator
  affiliation: Cedars-Sinai Medical Center
  last name: Clinical Trial Recruitment Navigator
  phone: 310-423-2133
  email: cancer.trial.info@cshs.org
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Cedars-Sinai Medical Center
  investigator full name: Alix G. Sleight, PhD
  investigator title: Associate Professor, Department of Physical Medicine and Rehabilitation
  mesh term: Colorectal Neoplasms