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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
166
Exposure to white light (10.000 lux) in the morning
Exposure to white light (10-20 lux) in the morning
Radboudumc
Nijmegen, Gelderland, Netherlands
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
VUmc
Amsterdam, North Holland, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Cancer related fatigue
Fatigue is assessed with the Multidimensional Fatigue Inventory
Time frame: Change from baseline fatigue at end of 3,5 weeks light therapy
Cancer related fatigue
Fatigue is assessed with the Multidimensional Fatigue
Time frame: Change from baseline fatigue at 3 months after light therapy
Cancer related fatigue
Fatigue is assessed with the Multidimensional Fatigue
Time frame: Change from baseline fatigue at 9 months after light therapy
Subjective sleep quality
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
Time frame: Change from baseline subjective sleep quality at end of 3,5 weeks light therapy
Subjective sleep quality
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
Time frame: Change from baseline subjective sleep quality at 3 months after light therapy
Subjective sleep quality
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
Time frame: Change from baseline subjective sleep quality at 9 months after light therapy
Objective sleep quality
Objective sleep quality data is assessed by wearing an accelerometer for 10 days
Time frame: Change from baseline objective sleep quality at end of 3,5 weeks light therapy
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Erasmus MC
Rotterdam, South Holland, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Admiraal de Ruyter ziekenhuis
Goes, Netherlands
Haga ziekenhuis
The Hague, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Objective sleep quality
Objective sleep quality data is assessed by wearing an accelerometer for 10 days
Time frame: Change from baseline objective sleep quality at 3 months after light therapy
Objective sleep quality
Objective sleep quality data is assessed by wearing an accelerometer for 10 days
Time frame: Change from baseline objective sleep quality at 9 months after light therapy
Depression
Depression is assessed with the Center for Epidemiological Studies - depression scale
Time frame: Change from baseline depression at end of 3,5 weeks light therapy
Depression
Depression is assessed with the Center for Epidemiological Studies - depression scale
Time frame: Change from baseline depression at 3 months after light therapy
Depression
Depression is assessed with the Center for Epidemiological Studies - depression scale
Time frame: Change from baseline depression at 9 months after light therapy
Anxiety
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
Time frame: Change from baseline anxiety at end of 3,5 weeks light therapy
Anxiety
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
Time frame: Change from baseline anxiety at 3 months after light therapy
Anxiety
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
Time frame: Change from baseline anxiety at 9 months after light therapy
Quality of life
Quality of life is assessed with the Medical Outcome studies short form (SF-36)
Time frame: Change from baseline quality of life at end of 3,5 weeks light therapy
Quality of life
Quality of life is assessed with the Medical Outcome studies short form (SF-36)
Time frame: Change from baseline quality of life at 3 months after light therapy
Quality of life
Quality of life is assessed with the Medical Outcome studies short form (SF-36)
Time frame: Change from baseline quality of life at 9 months after light therapy
Subjective cognitive complaints
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning.
Time frame: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
Time frame: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
Time frame: Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
Time frame: Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
Time frame: Change from baseline subjective cognitive complaints at 9 months after light therapy
Subjective cognitive complaints
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
Time frame: Change from baseline subjective cognitive complaints at 9 months after light therapy
Objective cognitive complaints - alertness and sustained attention
Objective cognitive complaints are assessed with the Psychomotor Vigilance Task.
Time frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints - long-term memory
Objective cognitive complaints are assessed with the 15 words test.
Time frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints - short-term memory
Objective cognitive complaints are assessed with the digit span task.
Time frame: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Cancer worries
Cancer worries is assessed with the Cancer Worry scale
Time frame: Change from baseline cancer worries at end of 3,5 weeks light therapy
Cancer worries
Cancer worries is assessed with the Cancer Worry scale
Time frame: Change from baseline cancer worries at 3 months after light therapy
Cancer worries
Cancer worries is assessed with the Cancer Worry scale
Time frame: Change from baseline cancer worries at 9 months after light therapy
Fatigue catastrophizing
Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale
Time frame: Baseline
Self-efficacy
Self-efficacy is assessed with the Self-efficacy Scale 28
Time frame: Baseline
Circadian rhythms of cortisol and melatonin
Circadian rhythms of cortisol and melatonin will be determined from saliva samples
Time frame: Change from baseline circadian rhythms at end of 3,5 weeks light therapy
Biomarkers of inflammation and genotype
Biomarkers of inflammation (hsIL-6, sTNF-RII, IL-1RA, hsCRP, vitamin D) and genotype will be determined from blood samples
Time frame: Change from baseline levels of biomarkers at end of 3,5 weeks light therapy