To Decrease Fatigue With Light Therapy (SPARKLE)

August 31, 2020 updated by: The Netherlands Cancer Institute

Improving Sleep Quality, Psychosocial Functioning, and Cancer Related Fatigue With Light Therapy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
166

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Den Haag, Netherlands, 2545 CH
        • Haga ziekenhuis
      • Dordrecht, Netherlands, 3300 AK
        • Albert Schweitzer Ziekenhuis
      • Goes, Netherlands, 3318 AT
        • Admiraal de Ruyter Ziekenhuis
      • Utrecht, Netherlands, 2508 GA
        • Universitair Medisch Centrum Utrecht
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboudumc
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066 CX
        • Netherlands Cancer Institute
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • VUmc
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2300 RC
        • Leids Universitair Medisch Centrum
      • Rotterdam, Zuid-Holland, Netherlands, 3000 CA
        • Erasmus MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A history of Hodgkin or DLBCL with a survivorship of ≥ 3 years.
  • The presence of moderate to severe fatigue symptoms since diagnosis of or treatment for Hodgkin lymphoma or DLBCL.

Exclusion Criteria:

  • Fatigue is explained by a somatic factor as defined in the guidelines of chronic fatigue syndrome of the Dutch internists association (NIV). When a somatic cause for fatigue is resolved by stable medication use ≥ 6 months, patients can be included in the current trial.
  • Pregnancy (until 3 months postnatal) or women who provide breast feeding
  • Extensive surgical operations in the past 3 months.
  • Current diagnosis of a psychiatric disorder (e.g. personality disorders, psychosis, bipolar disorder) which would limit participation.
  • Diagnosis of and treatment for a secondary malignancy in the past 12 months.
  • Presence of photophobia (abnormal intolerance to visual perception of light) or another eye disease that shows symptoms of photophobia (e.g. aniridia, retinitis pigmentosa, glaucoma).
  • Current or previous use of light therapy for more than 1 week.
  • Current employment in shift work.
  • Insufficient knowledge of the Dutch language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Light intensity 1
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.
Device: Light therapy intensity 1
Exposure to white light (10.000 lux) in the morning
Experimental: Light intensity 2
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.
Device: Light therapy intensity 2
Exposure to white light (10-20 lux) in the morning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cancer related fatigue
Time Frame: Change from baseline fatigue at end of 3,5 weeks light therapy
Fatigue is assessed with the Multidimensional Fatigue Inventory
Change from baseline fatigue at end of 3,5 weeks light therapy
Cancer related fatigue
Time Frame: Change from baseline fatigue at 3 months after light therapy
Fatigue is assessed with the Multidimensional Fatigue
Change from baseline fatigue at 3 months after light therapy
Cancer related fatigue
Time Frame: Change from baseline fatigue at 9 months after light therapy
Fatigue is assessed with the Multidimensional Fatigue
Change from baseline fatigue at 9 months after light therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective sleep quality
Time Frame: Change from baseline subjective sleep quality at end of 3,5 weeks light therapy
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
Change from baseline subjective sleep quality at end of 3,5 weeks light therapy
Subjective sleep quality
Time Frame: Change from baseline subjective sleep quality at 3 months after light therapy
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
Change from baseline subjective sleep quality at 3 months after light therapy
Subjective sleep quality
Time Frame: Change from baseline subjective sleep quality at 9 months after light therapy
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
Change from baseline subjective sleep quality at 9 months after light therapy
Objective sleep quality
Time Frame: Change from baseline objective sleep quality at end of 3,5 weeks light therapy
Objective sleep quality data is assessed by wearing an accelerometer for 10 days
Change from baseline objective sleep quality at end of 3,5 weeks light therapy
Objective sleep quality
Time Frame: Change from baseline objective sleep quality at 3 months after light therapy
Objective sleep quality data is assessed by wearing an accelerometer for 10 days
Change from baseline objective sleep quality at 3 months after light therapy
Objective sleep quality
Time Frame: Change from baseline objective sleep quality at 9 months after light therapy
Objective sleep quality data is assessed by wearing an accelerometer for 10 days
Change from baseline objective sleep quality at 9 months after light therapy
Depression
Time Frame: Change from baseline depression at end of 3,5 weeks light therapy
Depression is assessed with the Center for Epidemiological Studies - depression scale
Change from baseline depression at end of 3,5 weeks light therapy
Depression
Time Frame: Change from baseline depression at 3 months after light therapy
Depression is assessed with the Center for Epidemiological Studies - depression scale
Change from baseline depression at 3 months after light therapy
Depression
Time Frame: Change from baseline depression at 9 months after light therapy
Depression is assessed with the Center for Epidemiological Studies - depression scale
Change from baseline depression at 9 months after light therapy
Anxiety
Time Frame: Change from baseline anxiety at end of 3,5 weeks light therapy
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
Change from baseline anxiety at end of 3,5 weeks light therapy
Anxiety
Time Frame: Change from baseline anxiety at 3 months after light therapy
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
Change from baseline anxiety at 3 months after light therapy
Anxiety
Time Frame: Change from baseline anxiety at 9 months after light therapy
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
Change from baseline anxiety at 9 months after light therapy
Quality of life
Time Frame: Change from baseline quality of life at end of 3,5 weeks light therapy
Quality of life is assessed with the Medical Outcome studies short form (SF-36)
Change from baseline quality of life at end of 3,5 weeks light therapy
Quality of life
Time Frame: Change from baseline quality of life at 3 months after light therapy
Quality of life is assessed with the Medical Outcome studies short form (SF-36)
Change from baseline quality of life at 3 months after light therapy
Quality of life
Time Frame: Change from baseline quality of life at 9 months after light therapy
Quality of life is assessed with the Medical Outcome studies short form (SF-36)
Change from baseline quality of life at 9 months after light therapy
Subjective cognitive complaints
Time Frame: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning.
Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints
Time Frame: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints
Time Frame: Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints
Time Frame: Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints
Time Frame: Change from baseline subjective cognitive complaints at 9 months after light therapy
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
Change from baseline subjective cognitive complaints at 9 months after light therapy
Subjective cognitive complaints
Time Frame: Change from baseline subjective cognitive complaints at 9 months after light therapy
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
Change from baseline subjective cognitive complaints at 9 months after light therapy
Objective cognitive complaints - alertness and sustained attention
Time Frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints are assessed with the Psychomotor Vigilance Task.
Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints - long-term memory
Time Frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints are assessed with the 15 words test.
Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints - short-term memory
Time Frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints are assessed with the digit span task.
Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Cancer worries
Time Frame: Change from baseline cancer worries at end of 3,5 weeks light therapy
Cancer worries is assessed with the Cancer Worry scale
Change from baseline cancer worries at end of 3,5 weeks light therapy
Cancer worries
Time Frame: Change from baseline cancer worries at 3 months after light therapy
Cancer worries is assessed with the Cancer Worry scale
Change from baseline cancer worries at 3 months after light therapy
Cancer worries
Time Frame: Change from baseline cancer worries at 9 months after light therapy
Cancer worries is assessed with the Cancer Worry scale
Change from baseline cancer worries at 9 months after light therapy
Fatigue catastrophizing
Time Frame: Baseline
Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale
Baseline
Self-efficacy
Time Frame: Baseline
Self-efficacy is assessed with the Self-efficacy Scale 28
Baseline
Circadian rhythms of cortisol and melatonin
Time Frame: Change from baseline circadian rhythms at end of 3,5 weeks light therapy
Circadian rhythms of cortisol and melatonin will be determined from saliva samples
Change from baseline circadian rhythms at end of 3,5 weeks light therapy
Biomarkers of inflammation and genotype
Time Frame: Change from baseline levels of biomarkers at end of 3,5 weeks light therapy
Biomarkers of inflammation (hsIL-6, sTNF-RII, IL-1RA, hsCRP, vitamin D) and genotype will be determined from blood samples
Change from baseline levels of biomarkers at end of 3,5 weeks light therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Netherlands Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dutch Cancer Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eveline Bleiker, PhD, The Netherlands Cancer Institute
  • Principal Investigator: Flora van Leeuwen, Prof.dr.ir., The Netherlands Cancer Institute
  • Principal Investigator: Laurien Daniels, PhD, MD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL61017.031.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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