<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/NCT03806140</url>
  </required_header>
  <id_info>
    <org_study_id>14-010834</org_study_id>
    <nct_id>NCT03806140</nct_id>
  </id_info>
  <brief_title>Development and Evaluation of THRIVE</brief_title>
  <official_title>Proof-of-Concept of an Infrastructure for Text Messaging Interventions at CHOP: Development and Evaluation of THRIVE (Texting Health Resources to Inform, motiVate, and Engage)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Philadelphia</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>
      Investigators will test the feasibility and acceptability, as well as efficacy (exploratory&#xD;
      aim) of a text messaging intervention for Adolescents and young adults (AYA) transitioning&#xD;
      off active treatment for cancer. Texting Health Resources to Inform, motiVate, and Engage&#xD;
      (THRIVE) is intended to improve knowledge about health promotion and health vulnerability and&#xD;
      importance of continued engagement in care, while also providing support and improving&#xD;
      efficacy to achieve health-related goals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescents and young adults (AYA) with cancer are recognized as an understudied and&#xD;
      underserved population in oncology. AYA engagement in ongoing disease management is&#xD;
      compromised by lack of awareness of their continued health vulnerabilities and need for&#xD;
      continued care, their desire to be &quot;normal&quot; and remove themselves from the cancer experience,&#xD;
      and lack of AYA-appropriate support and services. Thus, AYA with cancer, especially those&#xD;
      completing active treatment, are extremely vulnerable and in need of support to maintain&#xD;
      remission and assure optimal health into adulthood. To address the immediate need for&#xD;
      innovative interventions targeting AYA completing cancer treatment, the proposed study will&#xD;
      test the efficacy, feasibility, and acceptability of a tailored text messaging intervention&#xD;
      for AYA transitioning off active treatment called THRIVE (Texting Health Resources to Inform,&#xD;
      motiVate, and Engage).&#xD;
&#xD;
      A pilot randomized controlled trial testing the acceptability and feasibility (primary) and&#xD;
      initial efficacy (secondary) of a health promoting mobile health texting intervention with&#xD;
      AYA transitioning off active cancer treatment to follow-up care.&#xD;
&#xD;
      The intervention compares a texting intervention to a receipt of an AYA survivorship&#xD;
      handbook. Acceptability and feasibility are primary outcomes. Efficacy outcomes include&#xD;
      measures of knowledge, healthcare utilization, adherence, engagement in care, and&#xD;
      psychosocial well-being measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">January 1, 2016</completion_date>
  <primary_completion_date type="Actual">January 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment</measure>
    <time_frame>16 weeks</time_frame>
    <description>All patients will complete a measure of acceptability at the outcome data collection-. The questionnaire consists of 27 items for the control group and 31 items for the intervention group. Items will be answered on a Likert-scale and one open-ended question intended to elicit suggestions for improving the intervention. Items pertain to perceived value, appropriateness, convenience and helpfulness of the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients completed 16 week measures</measure>
    <time_frame>16 weeks</time_frame>
    <description>Completion of follow-up measures which will be logged by research team for feasibility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patient-reported barriers to technology of text messages</measure>
    <time_frame>16 weeks</time_frame>
    <description>Number of participants who report barriers or issues with the text messages and technology for feasibility</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health competence beliefs</measure>
    <time_frame>16 weeks</time_frame>
    <description>Health Competence Beliefs Inventory (HBCI) survey - The HCBI assess beliefs about the psychological and functional impact of past medical issues, perceived competence to manage current and future medical issues, perceived medical vulnerability now and in the future, and perceived connection to/communication with others about medical issues. HCBI includes 4 subscales (autonomy, health vulnerability, cognitive competence, and satisfaction with health care). For this study, we are omitting the cognitive competence subscale, resulting in 16 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in health promoting behaviors</measure>
    <time_frame>16 weeks</time_frame>
    <description>Engagement in health promoting behaviors will be assessed using the Health Behavior Survey (HBS). This measure is composed of the 30-item Health Behavior Survey (HBS) that was developed for a previous study (Hocking, Schwartz, Hobbie et al., 2013). HBS alcoholic beverage consumption (4-items), smoking (2-items), other drug use (4-items), sunscreen use (1-item), health-screening (1-item), exercise (4-items), sexual behavior (3-items), and nutrition/weight (7-items). These items will be scored as either health promoting or health limiting (1 point for each health promoting behavior). The total score, as well as scores from each content area, will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health competence beliefs</measure>
    <time_frame>16 weeks</time_frame>
    <description>Perceived Health Competence Scale (PHCS) survey will be used to assess health competence beliefs. The survey is an 8-item instrument designed to assess perceived effectiveness carrying out health behaviors and influencing personal health outcomes. Participants rate each item on a 5-point Likert scale, from strongly disagree to strongly agree. Items yield a total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health related quality of life (HRQL) in adolescent and young adult survivors of childhood cancer</measure>
    <time_frame>16 weeks</time_frame>
    <description>Minneapolis-Manchester Quality of Life Instrument-adolescent (MMQL) survey will be used to measure health related quality of life in adolescent and young adult survivors of childhood cancer by assessing physical functioning, psychological functioning, social functioning, cognitive functioning, body image, outlook on life, and intimate relationships. Scores range from one to five, with a higher score indicating a better HRQL An overall QoL score is reached by finding the mean score for all the items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient adherence to clinic attendance</measure>
    <time_frame>16 weeks</time_frame>
    <description>Medical record review as well as completion of the Medical Adherence Measure (MAM) survey will be used to assess patient adherence to clinic attendance. The MAM assesses adherence. Patient adherence to medication and to clinic attendance are each rated on a 10-point scale (1 = never; 10 = always take medication). Participants also select barriers to adherence from a list of 12 and the option to write in another reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of health promoting behaviors</measure>
    <time_frame>16 weeks</time_frame>
    <description>Knowledge of health promoting behaviors will be assessed using the Knowledge Acquisition Measure questionnaire. The measure was developed by the research team for use in this study. The questionnaire consists of 23 multiple choice items regarding knowledge of basic health-promoting behaviors (e.g. recommended sunscreen use and maintenance of physical health) as well as five goal-specific questions that each participant will answer based on the goal he or she chose at the time of enrollment. All components of the Knowledge Acquisition Measure aim to assess the amount of health-related knowledge gained over the course of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sleep quality</measure>
    <time_frame>16 weeks</time_frame>
    <description>Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQUI) questionnaire- 19-item self-report questionnaire that measures subjective sleep quality and disturbance in adults over the past one-month period and discriminates &quot;good&quot; and &quot;poor&quot; sleepers (Buysse, Reynolds, Monk, Berman, &amp; Kupfer, 1989). The PSQI yields a global score (PSQI-G) and seven subscale scores consisting of Sleep Quality, Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Sleep Medications, and Daytime Dysfunction, with a global score of &gt; 5 thought to be suggestive of significant sleep disturbance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>16 weeks</time_frame>
    <description>Medical adherence will be assessed by medical record review as well as Medical Adherence Measure (MAM) - Patient adherence to medication and to clinic attendance are each rated on a 10-point scale (1 = never; 10 = always take medication). Participants also select barriers to adherence from a list of 12 and the option to write in another reason.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>16 weeks</time_frame>
    <description>Multidimensional fatigues scale (MFS) questionnaire will be used to assess fatigue. The measure is an 18- item questionnaire that yields a total score and three subscale scores: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue. Items are answered on a 5-point Likert-type scale indicating how problematic each element of fatigue was over the past month. Lower scores indicate more fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attainment of health related goals</measure>
    <time_frame>week 1 and 16</time_frame>
    <description>Goal Attainment Measure - was developed for this study, and assesses participants' expectation of (10-items) and progress related to achieving their chosen goal (9-items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient adherence to medication compliance</measure>
    <time_frame>26 weeks</time_frame>
    <description>medical record review</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Oncology</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive daily text messages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No text messages, only written educational materials</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>text messages</intervention_name>
    <description>receive about one health-related text message a day for 16 weeks</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with cancer&#xD;
&#xD;
          2. Males or females between the ages of 12 and 25&#xD;
&#xD;
          3. In remission (per documentation in chart)&#xD;
&#xD;
          4. Within 12 months of completing active treatment for cancer&#xD;
&#xD;
          5. Cognitively capable to complete measures (per documentation in chart of impairment or&#xD;
             parent or provider report).&#xD;
&#xD;
          6. Able to read and speak English.&#xD;
&#xD;
          7. Parent available to provide consent for those ages 12 to 17&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1)Subjects that do not meet inclusion criteria described above will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Schwartz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Texting</keyword>
  <keyword>mHealth</keyword>
  <keyword>Adolescents and young adults transitioning of treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03806140
org study id: 14-010834
nct id: NCT03806140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators will test the feasibility and acceptability, as well as efficacy (exploratory
      aim) of a text messaging intervention for Adolescents and young adults (AYA) transitioning
      off active treatment for cancer. Texting Health Resources to Inform, motiVate, and Engage
      (THRIVE) is intended to improve knowledge about health promotion and health vulnerability and
      importance of continued engagement in care, while also providing support and improving
      efficacy to achieve health-related goals.
Adolescents and young adults (AYA) with cancer are recognized as an understudied and
      underserved population in oncology. AYA engagement in ongoing disease management is
      compromised by lack of awareness of their continued health vulnerabilities and need for
      continued care, their desire to be "normal" and remove themselves from the cancer experience,
      and lack of AYA-appropriate support and services. Thus, AYA with cancer, especially those
      completing active treatment, are extremely vulnerable and in need of support to maintain
      remission and assure optimal health into adulthood. To address the immediate need for
      innovative interventions targeting AYA completing cancer treatment, the proposed study will
      test the efficacy, feasibility, and acceptability of a tailored text messaging intervention
      for AYA transitioning off active treatment called THRIVE (Texting Health Resources to Inform,
      motiVate, and Engage).

      A pilot randomized controlled trial testing the acceptability and feasibility (primary) and
      initial efficacy (secondary) of a health promoting mobile health texting intervention with
      AYA transitioning off active cancer treatment to follow-up care.

      The intervention compares a texting intervention to a receipt of an AYA survivorship
      handbook. Acceptability and feasibility are primary outcomes. Efficacy outcomes include
      measures of knowledge, healthcare utilization, adherence, engagement in care, and
      psychosocial well-being measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Acceptability of promoting a tailored text messaging intervention for AYA transitioning off active treatment
time frame: 16 weeks
description: All patients will complete a measure of acceptability at the outcome data collection-. The questionnaire consists of 27 items for the control group and 31 items for the intervention group. Items will be answered on a Likert-scale and one open-ended question intended to elicit suggestions for improving the intervention. Items pertain to perceived value, appropriateness, convenience and helpfulness of the intervention.
measure: Number of patients completed 16 week measures
time frame: 16 weeks
description: Completion of follow-up measures which will be logged by research team for feasibility
measure: Number of patient-reported barriers to technology of text messages
time frame: 16 weeks
description: Number of participants who report barriers or issues with the text messages and technology for feasibility
measure: Health competence beliefs
time frame: 16 weeks
description: Health Competence Beliefs Inventory (HBCI) survey - The HCBI assess beliefs about the psychological and functional impact of past medical issues, perceived competence to manage current and future medical issues, perceived medical vulnerability now and in the future, and perceived connection to/communication with others about medical issues. HCBI includes 4 subscales (autonomy, health vulnerability, cognitive competence, and satisfaction with health care). For this study, we are omitting the cognitive competence subscale, resulting in 16 items.
measure: Engagement in health promoting behaviors
time frame: 16 weeks
description: Engagement in health promoting behaviors will be assessed using the Health Behavior Survey (HBS). This measure is composed of the 30-item Health Behavior Survey (HBS) that was developed for a previous study (Hocking, Schwartz, Hobbie et al., 2013). HBS alcoholic beverage consumption (4-items), smoking (2-items), other drug use (4-items), sunscreen use (1-item), health-screening (1-item), exercise (4-items), sexual behavior (3-items), and nutrition/weight (7-items). These items will be scored as either health promoting or health limiting (1 point for each health promoting behavior). The total score, as well as scores from each content area, will be used.
measure: Changes in health competence beliefs
time frame: 16 weeks
description: Perceived Health Competence Scale (PHCS) survey will be used to assess health competence beliefs. The survey is an 8-item instrument designed to assess perceived effectiveness carrying out health behaviors and influencing personal health outcomes. Participants rate each item on a 5-point Likert scale, from strongly disagree to strongly agree. Items yield a total score.
measure: Changes in health related quality of life (HRQL) in adolescent and young adult survivors of childhood cancer
time frame: 16 weeks
description: Minneapolis-Manchester Quality of Life Instrument-adolescent (MMQL) survey will be used to measure health related quality of life in adolescent and young adult survivors of childhood cancer by assessing physical functioning, psychological functioning, social functioning, cognitive functioning, body image, outlook on life, and intimate relationships. Scores range from one to five, with a higher score indicating a better HRQL An overall QoL score is reached by finding the mean score for all the items.
measure: Patient adherence to clinic attendance
time frame: 16 weeks
description: Medical record review as well as completion of the Medical Adherence Measure (MAM) survey will be used to assess patient adherence to clinic attendance. The MAM assesses adherence. Patient adherence to medication and to clinic attendance are each rated on a 10-point scale (1 = never; 10 = always take medication). Participants also select barriers to adherence from a list of 12 and the option to write in another reason.
measure: Knowledge of health promoting behaviors
time frame: 16 weeks
description: Knowledge of health promoting behaviors will be assessed using the Knowledge Acquisition Measure questionnaire. The measure was developed by the research team for use in this study. The questionnaire consists of 23 multiple choice items regarding knowledge of basic health-promoting behaviors (e.g. recommended sunscreen use and maintenance of physical health) as well as five goal-specific questions that each participant will answer based on the goal he or she chose at the time of enrollment. All components of the Knowledge Acquisition Measure aim to assess the amount of health-related knowledge gained over the course of the intervention.
measure: Changes in sleep quality
time frame: 16 weeks
description: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQUI) questionnaire- 19-item self-report questionnaire that measures subjective sleep quality and disturbance in adults over the past one-month period and discriminates "good" and "poor" sleepers (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). The PSQI yields a global score (PSQI-G) and seven subscale scores consisting of Sleep Quality, Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Sleep Medications, and Daytime Dysfunction, with a global score of > 5 thought to be suggestive of significant sleep disturbance.
measure: Medication adherence
time frame: 16 weeks
description: Medical adherence will be assessed by medical record review as well as Medical Adherence Measure (MAM) - Patient adherence to medication and to clinic attendance are each rated on a 10-point scale (1 = never; 10 = always take medication). Participants also select barriers to adherence from a list of 12 and the option to write in another reason.
measure: Fatigue
time frame: 16 weeks
description: Multidimensional fatigues scale (MFS) questionnaire will be used to assess fatigue. The measure is an 18- item questionnaire that yields a total score and three subscale scores: General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue. Items are answered on a 5-point Likert-type scale indicating how problematic each element of fatigue was over the past month. Lower scores indicate more fatigue
measure: Attainment of health related goals
time frame: week 1 and 16
description: Goal Attainment Measure - was developed for this study, and assesses participants' expectation of (10-items) and progress related to achieving their chosen goal (9-items).
measure: Patient adherence to medication compliance
time frame: 26 weeks
description: medical record review
arm group label: Intervention group
arm group type: Active Comparator
description: Receive daily text messages
arm group label: Control group
arm group type: No Intervention
description: No text messages, only written educational materials
intervention type: Behavioral
intervention name: text messages
description: receive about one health-related text message a day for 16 weeks
arm group label: Intervention group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: No
last name: Lisa Schwartz, PhD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No