<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/NCT03242902</url>
  </required_header>
  <id_info>
    <org_study_id>NL61017.031.17</org_study_id>
    <nct_id>NCT03242902</nct_id>
  </id_info>
  <brief_title>To Decrease Fatigue With Light Therapy</brief_title>
  <acronym>SPARKLE</acronym>
  <official_title>Improving Sleep Quality, Psychosocial Functioning, and Cancer Related Fatigue With Light Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Netherlands Cancer Institute</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>
      Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term&#xD;
      complaints reported by (non-) Hodgkin survivors. The SPARKLE study will test the efficacy of&#xD;
      two intensities of light therapy on cancer related fatigue. Additionally, it explores&#xD;
      possible working mechanisms of light therapy on CRF including improvements in sleep quality,&#xD;
      psychosocial variables (depression, anxiety, cognitive complaints, and quality of life), and&#xD;
      changes in biological circadian rhythms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Cancer related fatigue (CRF) is one of the most prevalent and distressing&#xD;
      long-term complaints reported by (non-)Hodgkin survivors. So far, there is no standard&#xD;
      treatment. Some non-pharmacological interventions have shown large effects but show&#xD;
      limitations as well, e.g. they are labor intensive. A novel and promising treatment for CRF&#xD;
      is exposure to bright white light (BWL) therapy. This low-cost intervention is easy to&#xD;
      deliver and has a low burden for professionals as well as for patients.&#xD;
&#xD;
      Objective: To examine the efficacy of BWL therapy as an intervention for CRF. As a secondary&#xD;
      aim, this study will explore possible working mechanisms including changes in sleep quality,&#xD;
      psychological variables, biological circadian rhythms, sleep-wake cycles, inflammation&#xD;
      markers and genotype.&#xD;
&#xD;
      Study design: A multicenter randomized controlled trial will invite participants and allocate&#xD;
      them to either a light intensity 1 condition (n=80) or a light intensity 2 condition (n=80).&#xD;
      The longitudinal design will include four measurement points: baseline, mid-intervention,&#xD;
      post-intervention, and at 3 and 9 months follow-up.&#xD;
&#xD;
      Study population: Hodgkin and diffuse large B-cell lymphoma (DLBCL) survivors fulfilling the&#xD;
      clinical criteria of CRF and a survivorship of ≥ 3 years will be invited. Fatigue should not&#xD;
      be attributable to a clear somatic cause or treatment for secondary cancer in the past year.&#xD;
      Moreover, 25 Hodgkin survivors without CRF will be recruited to explore the association&#xD;
      between circadian rhythms and CRF.&#xD;
&#xD;
      Intervention: The light intervention includes exposure to light for 30 minutes within the&#xD;
      first half hour after awakening during 3,5 weeks.&#xD;
&#xD;
      Main study parameters/endpoints: The main study parameter in this study is the change in CRF&#xD;
      from baseline to post-intervention and at 3 and 9 months follow-up. This will be assessed&#xD;
      with the Multidimensional Fatigue Inventory.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: Participation in this study includes completion of a light intervention for 3,5&#xD;
      weeks (30 min each day) and 2 visits (1h) to the treating hospital pre- and&#xD;
      post-intervention. The visits aim to provide instructions and equipment and to collect two&#xD;
      blood samples. Additionally, 5 saliva samples will be collected by the participant at home&#xD;
      pre- and post-intervention. Moreover, participants complete questionnaires (30 min, 4 times)&#xD;
      and wear an accelerometer (10d, 4 times and during light therapy) to objectively measure&#xD;
      sleep quality and activity. Risks of the light intervention are limited, although there are&#xD;
      few known reports of agitation, headache and nausea during the first days of light exposure.&#xD;
      Benefits are the use of an easy to administer treatment for one of the most distressing&#xD;
      symptoms that participants report.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">August 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 25, 2019</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cancer related fatigue</measure>
    <time_frame>Change from baseline fatigue at end of 3,5 weeks light therapy</time_frame>
    <description>Fatigue is assessed with the Multidimensional Fatigue Inventory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer related fatigue</measure>
    <time_frame>Change from baseline fatigue at 3 months after light therapy</time_frame>
    <description>Fatigue is assessed with the Multidimensional Fatigue</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer related fatigue</measure>
    <time_frame>Change from baseline fatigue at 9 months after light therapy</time_frame>
    <description>Fatigue is assessed with the Multidimensional Fatigue</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality</measure>
    <time_frame>Change from baseline subjective sleep quality at end of 3,5 weeks light therapy</time_frame>
    <description>Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality</measure>
    <time_frame>Change from baseline subjective sleep quality at 3 months after light therapy</time_frame>
    <description>Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective sleep quality</measure>
    <time_frame>Change from baseline subjective sleep quality at 9 months after light therapy</time_frame>
    <description>Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective sleep quality</measure>
    <time_frame>Change from baseline objective sleep quality at end of 3,5 weeks light therapy</time_frame>
    <description>Objective sleep quality data is assessed by wearing an accelerometer for 10 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective sleep quality</measure>
    <time_frame>Change from baseline objective sleep quality at 3 months after light therapy</time_frame>
    <description>Objective sleep quality data is assessed by wearing an accelerometer for 10 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective sleep quality</measure>
    <time_frame>Change from baseline objective sleep quality at 9 months after light therapy</time_frame>
    <description>Objective sleep quality data is assessed by wearing an accelerometer for 10 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline depression at end of 3,5 weeks light therapy</time_frame>
    <description>Depression is assessed with the Center for Epidemiological Studies - depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline depression at 3 months after light therapy</time_frame>
    <description>Depression is assessed with the Center for Epidemiological Studies - depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Change from baseline depression at 9 months after light therapy</time_frame>
    <description>Depression is assessed with the Center for Epidemiological Studies - depression scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline anxiety at end of 3,5 weeks light therapy</time_frame>
    <description>Anxiety is assessed with the State Trait Anxiety Inventory-6 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline anxiety at 3 months after light therapy</time_frame>
    <description>Anxiety is assessed with the State Trait Anxiety Inventory-6 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Change from baseline anxiety at 9 months after light therapy</time_frame>
    <description>Anxiety is assessed with the State Trait Anxiety Inventory-6 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Change from baseline quality of life at end of 3,5 weeks light therapy</time_frame>
    <description>Quality of life is assessed with the Medical Outcome studies short form (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Change from baseline quality of life at 3 months after light therapy</time_frame>
    <description>Quality of life is assessed with the Medical Outcome studies short form (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Change from baseline quality of life at 9 months after light therapy</time_frame>
    <description>Quality of life is assessed with the Medical Outcome studies short form (SF-36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective cognitive complaints</measure>
    <time_frame>Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy</time_frame>
    <description>Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective cognitive complaints</measure>
    <time_frame>Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy</time_frame>
    <description>Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective cognitive complaints</measure>
    <time_frame>Change from baseline subjective cognitive complaints at 3 months after light therapy</time_frame>
    <description>Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective cognitive complaints</measure>
    <time_frame>Change from baseline subjective cognitive complaints at 3 months after light therapy</time_frame>
    <description>Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective cognitive complaints</measure>
    <time_frame>Change from baseline subjective cognitive complaints at 9 months after light therapy</time_frame>
    <description>Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective cognitive complaints</measure>
    <time_frame>Change from baseline subjective cognitive complaints at 9 months after light therapy</time_frame>
    <description>Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective cognitive complaints - alertness and sustained attention</measure>
    <time_frame>Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy</time_frame>
    <description>Objective cognitive complaints are assessed with the Psychomotor Vigilance Task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective cognitive complaints - long-term memory</measure>
    <time_frame>Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy</time_frame>
    <description>Objective cognitive complaints are assessed with the 15 words test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective cognitive complaints - short-term memory</measure>
    <time_frame>Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy</time_frame>
    <description>Objective cognitive complaints are assessed with the digit span task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer worries</measure>
    <time_frame>Change from baseline cancer worries at end of 3,5 weeks light therapy</time_frame>
    <description>Cancer worries is assessed with the Cancer Worry scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer worries</measure>
    <time_frame>Change from baseline cancer worries at 3 months after light therapy</time_frame>
    <description>Cancer worries is assessed with the Cancer Worry scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer worries</measure>
    <time_frame>Change from baseline cancer worries at 9 months after light therapy</time_frame>
    <description>Cancer worries is assessed with the Cancer Worry scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue catastrophizing</measure>
    <time_frame>Baseline</time_frame>
    <description>Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-efficacy is assessed with the Self-efficacy Scale 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian rhythms of cortisol and melatonin</measure>
    <time_frame>Change from baseline circadian rhythms at end of 3,5 weeks light therapy</time_frame>
    <description>Circadian rhythms of cortisol and melatonin will be determined from saliva samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of inflammation and genotype</measure>
    <time_frame>Change from baseline levels of biomarkers at end of 3,5 weeks light therapy</time_frame>
    <description>Biomarkers of inflammation (hsIL-6, sTNF-RII, IL-1RA, hsCRP, vitamin D) and genotype will be determined from blood samples</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Hodgkin Lymphoma</condition>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Light intensity 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The light intervention includes exposure to white light (10.000 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Light intensity 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The light intervention includes exposure to white light (10-20 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Light therapy intensity 1</intervention_name>
    <description>Exposure to white light (10.000 lux) in the morning</description>
    <arm_group_label>Light intensity 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Light therapy intensity 2</intervention_name>
    <description>Exposure to white light (10-20 lux) in the morning</description>
    <arm_group_label>Light intensity 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A history of Hodgkin or DLBCL with a survivorship of ≥ 3 years.&#xD;
&#xD;
          -  The presence of moderate to severe fatigue symptoms since diagnosis of or treatment&#xD;
             for Hodgkin lymphoma or DLBCL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fatigue is explained by a somatic factor as defined in the guidelines of chronic&#xD;
             fatigue syndrome of the Dutch internists association (NIV). When a somatic cause for&#xD;
             fatigue is resolved by stable medication use ≥ 6 months, patients can be included in&#xD;
             the current trial.&#xD;
&#xD;
          -  Pregnancy (until 3 months postnatal) or women who provide breast feeding&#xD;
&#xD;
          -  Extensive surgical operations in the past 3 months.&#xD;
&#xD;
          -  Current diagnosis of a psychiatric disorder (e.g. personality disorders, psychosis,&#xD;
             bipolar disorder) which would limit participation.&#xD;
&#xD;
          -  Diagnosis of and treatment for a secondary malignancy in the past 12 months.&#xD;
&#xD;
          -  Presence of photophobia (abnormal intolerance to visual perception of light) or&#xD;
             another eye disease that shows symptoms of photophobia (e.g. aniridia, retinitis&#xD;
             pigmentosa, glaucoma).&#xD;
&#xD;
          -  Current or previous use of light therapy for more than 1 week.&#xD;
&#xD;
          -  Current employment in shift work.&#xD;
&#xD;
          -  Insufficient knowledge of the Dutch language.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eveline Bleiker, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Netherlands Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Flora van Leeuwen, Prof.dr.ir.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Netherlands Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laurien Daniels, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netherlands Cancer Institute</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VUmc</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum</name>
      <address>
        <city>Leiden</city>
        <state>Zuid-Holland</state>
        <zip>2300 RC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3000 CA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haga ziekenhuis</name>
      <address>
        <city>Den Haag</city>
        <zip>2545 CH</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Ziekenhuis</name>
      <address>
        <city>Dordrecht</city>
        <zip>3300 AK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Admiraal de Ruyter ziekenhuis</name>
      <address>
        <city>Goes</city>
        <zip>3318 AT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>2508 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>light therapy</keyword>
  <keyword>cancer related fatigue</keyword>
  <keyword>sleep quality</keyword>
  <keyword>biological rhythms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03242902
org study id: NL61017.031.17
nct id: NCT03242902
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term
      complaints reported by (non-) Hodgkin survivors. The SPARKLE study will test the efficacy of
      two intensities of light therapy on cancer related fatigue. Additionally, it explores
      possible working mechanisms of light therapy on CRF including improvements in sleep quality,
      psychosocial variables (depression, anxiety, cognitive complaints, and quality of life), and
      changes in biological circadian rhythms.
Rationale: Cancer related fatigue (CRF) is one of the most prevalent and distressing
      long-term complaints reported by (non-)Hodgkin survivors. So far, there is no standard
      treatment. Some non-pharmacological interventions have shown large effects but show
      limitations as well, e.g. they are labor intensive. A novel and promising treatment for CRF
      is exposure to bright white light (BWL) therapy. This low-cost intervention is easy to
      deliver and has a low burden for professionals as well as for patients.

      Objective: To examine the efficacy of BWL therapy as an intervention for CRF. As a secondary
      aim, this study will explore possible working mechanisms including changes in sleep quality,
      psychological variables, biological circadian rhythms, sleep-wake cycles, inflammation
      markers and genotype.

      Study design: A multicenter randomized controlled trial will invite participants and allocate
      them to either a light intensity 1 condition (n=80) or a light intensity 2 condition (n=80).
      The longitudinal design will include four measurement points: baseline, mid-intervention,
      post-intervention, and at 3 and 9 months follow-up.

      Study population: Hodgkin and diffuse large B-cell lymphoma (DLBCL) survivors fulfilling the
      clinical criteria of CRF and a survivorship of ≥ 3 years will be invited. Fatigue should not
      be attributable to a clear somatic cause or treatment for secondary cancer in the past year.
      Moreover, 25 Hodgkin survivors without CRF will be recruited to explore the association
      between circadian rhythms and CRF.

      Intervention: The light intervention includes exposure to light for 30 minutes within the
      first half hour after awakening during 3,5 weeks.

      Main study parameters/endpoints: The main study parameter in this study is the change in CRF
      from baseline to post-intervention and at 3 and 9 months follow-up. This will be assessed
      with the Multidimensional Fatigue Inventory.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Participation in this study includes completion of a light intervention for 3,5
      weeks (30 min each day) and 2 visits (1h) to the treating hospital pre- and
      post-intervention. The visits aim to provide instructions and equipment and to collect two
      blood samples. Additionally, 5 saliva samples will be collected by the participant at home
      pre- and post-intervention. Moreover, participants complete questionnaires (30 min, 4 times)
      and wear an accelerometer (10d, 4 times and during light therapy) to objectively measure
      sleep quality and activity. Risks of the light intervention are limited, although there are
      few known reports of agitation, headache and nausea during the first days of light exposure.
      Benefits are the use of an easy to administer treatment for one of the most distressing
      symptoms that participants report.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Cancer related fatigue
time frame: Change from baseline fatigue at end of 3,5 weeks light therapy
description: Fatigue is assessed with the Multidimensional Fatigue Inventory
measure: Cancer related fatigue
time frame: Change from baseline fatigue at 3 months after light therapy
description: Fatigue is assessed with the Multidimensional Fatigue
measure: Cancer related fatigue
time frame: Change from baseline fatigue at 9 months after light therapy
description: Fatigue is assessed with the Multidimensional Fatigue
measure: Subjective sleep quality
time frame: Change from baseline subjective sleep quality at end of 3,5 weeks light therapy
description: Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
measure: Subjective sleep quality
time frame: Change from baseline subjective sleep quality at 3 months after light therapy
description: Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
measure: Subjective sleep quality
time frame: Change from baseline subjective sleep quality at 9 months after light therapy
description: Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
measure: Objective sleep quality
time frame: Change from baseline objective sleep quality at end of 3,5 weeks light therapy
description: Objective sleep quality data is assessed by wearing an accelerometer for 10 days
measure: Objective sleep quality
time frame: Change from baseline objective sleep quality at 3 months after light therapy
description: Objective sleep quality data is assessed by wearing an accelerometer for 10 days
measure: Objective sleep quality
time frame: Change from baseline objective sleep quality at 9 months after light therapy
description: Objective sleep quality data is assessed by wearing an accelerometer for 10 days
measure: Depression
time frame: Change from baseline depression at end of 3,5 weeks light therapy
description: Depression is assessed with the Center for Epidemiological Studies - depression scale
measure: Depression
time frame: Change from baseline depression at 3 months after light therapy
description: Depression is assessed with the Center for Epidemiological Studies - depression scale
measure: Depression
time frame: Change from baseline depression at 9 months after light therapy
description: Depression is assessed with the Center for Epidemiological Studies - depression scale
measure: Anxiety
time frame: Change from baseline anxiety at end of 3,5 weeks light therapy
description: Anxiety is assessed with the State Trait Anxiety Inventory-6 items
measure: Anxiety
time frame: Change from baseline anxiety at 3 months after light therapy
description: Anxiety is assessed with the State Trait Anxiety Inventory-6 items
measure: Anxiety
time frame: Change from baseline anxiety at 9 months after light therapy
description: Anxiety is assessed with the State Trait Anxiety Inventory-6 items
measure: Quality of life
time frame: Change from baseline quality of life at end of 3,5 weeks light therapy
description: Quality of life is assessed with the Medical Outcome studies short form (SF-36)
measure: Quality of life
time frame: Change from baseline quality of life at 3 months after light therapy
description: Quality of life is assessed with the Medical Outcome studies short form (SF-36)
measure: Quality of life
time frame: Change from baseline quality of life at 9 months after light therapy
description: Quality of life is assessed with the Medical Outcome studies short form (SF-36)
measure: Subjective cognitive complaints
time frame: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
description: Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning.
measure: Subjective cognitive complaints
time frame: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
description: Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
measure: Subjective cognitive complaints
time frame: Change from baseline subjective cognitive complaints at 3 months after light therapy
description: Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
measure: Subjective cognitive complaints
time frame: Change from baseline subjective cognitive complaints at 3 months after light therapy
description: Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
measure: Subjective cognitive complaints
time frame: Change from baseline subjective cognitive complaints at 9 months after light therapy
description: Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
measure: Subjective cognitive complaints
time frame: Change from baseline subjective cognitive complaints at 9 months after light therapy
description: Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
measure: Objective cognitive complaints - alertness and sustained attention
time frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
description: Objective cognitive complaints are assessed with the Psychomotor Vigilance Task.
measure: Objective cognitive complaints - long-term memory
time frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
description: Objective cognitive complaints are assessed with the 15 words test.
measure: Objective cognitive complaints - short-term memory
time frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
description: Objective cognitive complaints are assessed with the digit span task.
measure: Cancer worries
time frame: Change from baseline cancer worries at end of 3,5 weeks light therapy
description: Cancer worries is assessed with the Cancer Worry scale
measure: Cancer worries
time frame: Change from baseline cancer worries at 3 months after light therapy
description: Cancer worries is assessed with the Cancer Worry scale
measure: Cancer worries
time frame: Change from baseline cancer worries at 9 months after light therapy
description: Cancer worries is assessed with the Cancer Worry scale
measure: Fatigue catastrophizing
time frame: Baseline
description: Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale
measure: Self-efficacy
time frame: Baseline
description: Self-efficacy is assessed with the Self-efficacy Scale 28
measure: Circadian rhythms of cortisol and melatonin
time frame: Change from baseline circadian rhythms at end of 3,5 weeks light therapy
description: Circadian rhythms of cortisol and melatonin will be determined from saliva samples
measure: Biomarkers of inflammation and genotype
time frame: Change from baseline levels of biomarkers at end of 3,5 weeks light therapy
description: Biomarkers of inflammation (hsIL-6, sTNF-RII, IL-1RA, hsCRP, vitamin D) and genotype will be determined from blood samples
arm group label: Light intensity 1
arm group type: Experimental
description: The light intervention includes exposure to white light (10.000 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.
arm group label: Light intensity 2
arm group type: Experimental
description: The light intervention includes exposure to white light (10-20 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.
intervention type: Device
intervention name: Light therapy intensity 1
description: Exposure to white light (10.000 lux) in the morning
arm group label: Light intensity 1
intervention type: Device
intervention name: Light therapy intensity 2
description: Exposure to white light (10-20 lux) in the morning
arm group label: Light intensity 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Eveline Bleiker, PhD
role: Principal Investigator
affiliation: The Netherlands Cancer Institute
last name: Flora van Leeuwen, Prof.dr.ir.
role: Principal Investigator
affiliation: The Netherlands Cancer Institute
last name: Laurien Daniels, PhD, MD
role: Principal Investigator
affiliation: Leiden University Medical Center
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country: Netherlands
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Fatigue
sharing ipd: Undecided