<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/NCT03282214</url>
  </required_header>
  <id_info>
    <org_study_id>D43TW009883</org_study_id>
    <nct_id>NCT03282214</nct_id>
  </id_info>
  <brief_title>A Self-Management Energy Conservation Program for Cancer-Related Fatigue</brief_title>
  <official_title>A Self-Management Energy Conservation Program for Cancer-Related Fatigue in Thai Women With Breast Cancer Receiving Chemotherapy: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Praboromarajchanok Institute, Ministry of Public Health, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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 purpose of this pilot study is to examine a 12-week self-management energy conservation&#xD;
      program (ECAM)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and&#xD;
      depression, self-efficacy, and beliefs about fatigue in a group of Thai women with breast&#xD;
      cancer who are undergoing chemotherapy. We will also evaluate how well women like the&#xD;
      intervention, how easy it is to use and whether women will do the activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer-related fatigue is a distressing and multidimensional symptom. Research in the US has&#xD;
      explored the efficacy of energy conservation interventions for fatigue and related symptoms&#xD;
      but no previous ECAM programs have been tested in Thailand.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">May 9, 2018</completion_date>
  <primary_completion_date type="Actual">February 14, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cancer-related fatigue (CRF)</measure>
    <time_frame>Change from baseline CRF scores at 12 weeks</time_frame>
    <description>A 22-item scale, 0 to 10 numerical scaling, with four dimensions of fatigue will be used to measure CRF severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>at 12 weeks</time_frame>
    <description>Open-ended questions will be used to ask about the most positive and negative aspects of the intervention, what modules did they use the most, what were barriers to using the intervention, what would they like to see added or deleted in future modules, and any suggestions on how the program could be improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction</measure>
    <time_frame>at 12 weeks</time_frame>
    <description>Scaling questions about satisfaction with the intervention will be responded on a 5-point scale (1 = dissatisfied to 5 = completely satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The General Sleep Disturbance (GSD)</measure>
    <time_frame>Change from baseline GSD scores at 12 weeks</time_frame>
    <description>A 21-item, eight-point Likert scale from 0 (never) to 7 (every day) will be used to measure subjective sleep disturbance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity (subjective measure)</measure>
    <time_frame>Change from baseline GSLTPAG scores at 12 weeks</time_frame>
    <description>Godin Leisure-Time Physical Activity Questionnaire (GSLTPAQ): A 4-item self-administered questionnaire asking information about the number of times one engages in mild, moderate, and strenuous leisure-time physical activity bouts of at least 15 minutes duration in a week, and also asking how often participants typically engage in any regular activity until sweating or a racing heart on a scale of often, sometimes, never or rarely.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity (objective measure)</measure>
    <time_frame>Changes from baseline steps per day at 12 weeks</time_frame>
    <description>A pedometer will be used to assess how many steps are taken each day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Change from baseline HADS scores at 12 weeks</time_frame>
    <description>The HADS is a 14-item questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)</measure>
    <time_frame>Change from baseline SEMCDS scores at 12 weeks</time_frame>
    <description>This 6-item scale contain items will be used to measures self-reported current level of confidence to manage control the patient's symptoms, role function, emotional functioning, and communicating with physicians.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Belief Questions (FBQ)</measure>
    <time_frame>Change from baseline FBQ scores at 12 weeks</time_frame>
    <description>A 20-item, six-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) will be used to measure the fatigue beliefs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Cancer-related Problem/Condition</condition>
  <condition>Cancer, Breast</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Self-management energy conservation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thai women with breast cancer randomized to the group will receive four sessions approximately every three weeks with the PI. The women will be instructed on how to do a self-management energy conservation program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants will be given two pamphlets (general issues about breast cancer and self-care activities for patients receiving chemotherapy) provided by the health care team at the study sites. The participants in the control group will be encouraged to maintain their current daily activities during the 12-week period The participants will wear a pedometer to record the number of steps which is one of the activity outcomes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-management energy conservation</intervention_name>
    <description>The experimental group will receive four sessions approximately every three weeks with the PI. These sessions will correspond to the cycles of chemotherapy they will receive, with the first two sessions being during cycle 1, and sessions 3 and 4 being during cycles 2 and 3 of chemotherapy, respectively. The women will be instructed on how to assess their activity patterns by making a list prioritizing their usual activities. The journal and priority list (a &quot;to do&quot; list) provide the basis for the second session. In this session, the participant will learn to create a plan for managing valued activities to minimize the amount of energy used, to report the fatigue experienced during and after an activity done in the journal and will learn strategies to manage fatigue and optimize activity. In the third session, the participant will evaluate and revise their individualized plan. In addition, the participant will be instructed to wear a pedometer to record objective physical activity.</description>
    <arm_group_label>Self-management energy conservation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thai women are age 18 or older; are diagnosed with stage I-III breast cancer; are&#xD;
             scheduled to receive at least four cycles of chemotherapy given in 21-day-intervals;&#xD;
             report at least 4 out of 10 or higher on a fatigue scale in the past month; are able&#xD;
             to read and write in Thai and can be contacted by telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Thai women have a history of severe psychiatric illness, or have other illnesses that&#xD;
             could be responsible for the fatigue other than cancer such as iron deficiency anemia,&#xD;
             multiple sclerosis, congestive heart failure, chronic fatigue syndrome or&#xD;
             fibromyalgia. With regard to anemia, women must have a certain hemoglobin in the&#xD;
             normal range at baseline. They also cannot have acute or chronic bone, joint, or&#xD;
             muscular abnormalities that would increase the risk of falls and injury. Women&#xD;
             scheduled to receive concurrent radiation therapy are not eligible.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Thai women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>School of Nursing</last_name>
    <role>Study Chair</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lopburi Cancer Hospital</name>
      <address>
        <city>Lopburi</city>
        <zip>15000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saraburi Hospital</name>
      <address>
        <city>Saraburi</city>
        <zip>18000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>May 19, 2018</last_update_submitted>
  <last_update_submitted_qc>May 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Wipasiri Naraphong</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <keyword>Energy conservation</keyword>
  <keyword>Self management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data for all primary and secondary outcome measures will be available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months of study completion.</ipd_time_frame>
  </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/NCT03282214
org study id: D43TW009883
nct id: NCT03282214
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to examine a 12-week self-management energy conservation
      program (ECAM)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and
      depression, self-efficacy, and beliefs about fatigue in a group of Thai women with breast
      cancer who are undergoing chemotherapy. We will also evaluate how well women like the
      intervention, how easy it is to use and whether women will do the activities.
Cancer-related fatigue is a distressing and multidimensional symptom. Research in the US has
      explored the efficacy of energy conservation interventions for fatigue and related symptoms
      but no previous ECAM programs have been tested in Thailand.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Cancer-related fatigue (CRF)
time frame: Change from baseline CRF scores at 12 weeks
description: A 22-item scale, 0 to 10 numerical scaling, with four dimensions of fatigue will be used to measure CRF severity.
measure: Acceptability
time frame: at 12 weeks
description: Open-ended questions will be used to ask about the most positive and negative aspects of the intervention, what modules did they use the most, what were barriers to using the intervention, what would they like to see added or deleted in future modules, and any suggestions on how the program could be improved.
measure: Satisfaction
time frame: at 12 weeks
description: Scaling questions about satisfaction with the intervention will be responded on a 5-point scale (1 = dissatisfied to 5 = completely satisfied).
measure: The General Sleep Disturbance (GSD)
time frame: Change from baseline GSD scores at 12 weeks
description: A 21-item, eight-point Likert scale from 0 (never) to 7 (every day) will be used to measure subjective sleep disturbance.
measure: Physical Activity (subjective measure)
time frame: Change from baseline GSLTPAG scores at 12 weeks
description: Godin Leisure-Time Physical Activity Questionnaire (GSLTPAQ): A 4-item self-administered questionnaire asking information about the number of times one engages in mild, moderate, and strenuous leisure-time physical activity bouts of at least 15 minutes duration in a week, and also asking how often participants typically engage in any regular activity until sweating or a racing heart on a scale of often, sometimes, never or rarely.
measure: Physical Activity (objective measure)
time frame: Changes from baseline steps per day at 12 weeks
description: A pedometer will be used to assess how many steps are taken each day.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Change from baseline HADS scores at 12 weeks
description: The HADS is a 14-item questionnaire
measure: Self-Efficacy for Managing Chronic Disease Scale (SEMCDS)
time frame: Change from baseline SEMCDS scores at 12 weeks
description: This 6-item scale contain items will be used to measures self-reported current level of confidence to manage control the patient's symptoms, role function, emotional functioning, and communicating with physicians.
measure: Fatigue Belief Questions (FBQ)
time frame: Change from baseline FBQ scores at 12 weeks
description: A 20-item, six-point Likert scale from 1 (strongly disagree) to 6 (strongly agree) will be used to measure the fatigue beliefs.
arm group label: Self-management energy conservation
arm group type: Experimental
description: Thai women with breast cancer randomized to the group will receive four sessions approximately every three weeks with the PI. The women will be instructed on how to do a self-management energy conservation program.
arm group label: Control
arm group type: No Intervention
description: The participants will be given two pamphlets (general issues about breast cancer and self-care activities for patients receiving chemotherapy) provided by the health care team at the study sites. The participants in the control group will be encouraged to maintain their current daily activities during the 12-week period The participants will wear a pedometer to record the number of steps which is one of the activity outcomes.
intervention type: Behavioral
intervention name: Self-management energy conservation
description: The experimental group will receive four sessions approximately every three weeks with the PI. These sessions will correspond to the cycles of chemotherapy they will receive, with the first two sessions being during cycle 1, and sessions 3 and 4 being during cycles 2 and 3 of chemotherapy, respectively. The women will be instructed on how to assess their activity patterns by making a list prioritizing their usual activities. The journal and priority list (a "to do" list) provide the basis for the second session. In this session, the participant will learn to create a plan for managing valued activities to minimize the amount of energy used, to report the fatigue experienced during and after an activity done in the journal and will learn strategies to manage fatigue and optimize activity. In the third session, the participant will evaluate and revise their individualized plan. In addition, the participant will be instructed to wear a pedometer to record objective physical activity.
arm group label: Self-management energy conservation
criteria: 
gender: Female
gender based: Yes
gender description: Thai women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: School of Nursing
role: Study Chair
affiliation: University of Michigan
facility: 
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Wipasiri Naraphong
investigator title: Postdoctoral Fellow
mesh term: Breast Neoplasms
mesh term: Fatigue
sharing ipd: Yes
ipd description: De-identified individual participant data for all primary and secondary outcome measures will be available
ipd info type: Study Protocol
ipd time frame: Data will be available within 6 months of study completion.