SPARKLE: To Decrease Fatigue With Light Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Cancer related fatigue [Change from baseline fatigue at end of 3,5 weeks light therapy]
Fatigue is assessed with the Multidimensional Fatigue Inventory
- Cancer related fatigue [Change from baseline fatigue at 3 months after light therapy]
Fatigue is assessed with the Multidimensional Fatigue
- Cancer related fatigue [Change from baseline fatigue at 9 months after light therapy]
Fatigue is assessed with the Multidimensional Fatigue
Secondary Outcome Measures
- Subjective sleep quality [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
- Subjective sleep quality [Change from baseline subjective sleep quality at 3 months after light therapy]
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
- Subjective sleep quality [Change from baseline subjective sleep quality at 9 months after light therapy]
Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index
- Objective sleep quality [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
- Objective sleep quality [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
- Objective sleep quality [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
- Depression [Change from baseline depression at end of 3,5 weeks light therapy]
Depression is assessed with the Center for Epidemiological Studies - depression scale
- Depression [Change from baseline depression at 3 months after light therapy]
Depression is assessed with the Center for Epidemiological Studies - depression scale
- Depression [Change from baseline depression at 9 months after light therapy]
Depression is assessed with the Center for Epidemiological Studies - depression scale
- Anxiety [Change from baseline anxiety at end of 3,5 weeks light therapy]
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
- Anxiety [Change from baseline anxiety at 3 months after light therapy]
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
- Anxiety [Change from baseline anxiety at 9 months after light therapy]
Anxiety is assessed with the State Trait Anxiety Inventory-6 items
- Quality of life [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)
- Quality of life [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)
- Quality of life [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)
- Subjective cognitive complaints [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.
- Subjective cognitive complaints [Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy]
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
- Subjective cognitive complaints [Change from baseline subjective cognitive complaints at 3 months after light therapy]
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
- Subjective cognitive complaints [Change from baseline subjective cognitive complaints at 3 months after light therapy]
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
- Subjective cognitive complaints [Change from baseline subjective cognitive complaints at 9 months after light therapy]
Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning
- Subjective cognitive complaints [Change from baseline subjective cognitive complaints at 9 months after light therapy]
Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory
- Objective cognitive complaints - alertness and sustained attention [Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy]
Objective cognitive complaints are assessed with the Psychomotor Vigilance Task.
- Objective cognitive complaints - long-term memory [Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy]
Objective cognitive complaints are assessed with the 15 words test.
- Objective cognitive complaints - short-term memory [Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy]
Objective cognitive complaints are assessed with the digit span task.
- Cancer worries [Change from baseline cancer worries at end of 3,5 weeks light therapy]
Cancer worries is assessed with the Cancer Worry scale
- Cancer worries [Change from baseline cancer worries at 3 months after light therapy]
Cancer worries is assessed with the Cancer Worry scale
- Cancer worries [Change from baseline cancer worries at 9 months after light therapy]
Cancer worries is assessed with the Cancer Worry scale
- Fatigue catastrophizing [Baseline]
Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale
- Self-efficacy [Baseline]
Self-efficacy is assessed with the Self-efficacy Scale 28
- Circadian rhythms of cortisol and melatonin [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
- Biomarkers of inflammation and genotype [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
Eligibility Criteria
Criteria
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.
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Pregnancy (until 3 months postnatal) or women who provide breast feeding
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Extensive surgical operations in the past 3 months.
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Current diagnosis of a psychiatric disorder (e.g. personality disorders, psychosis, bipolar disorder) which would limit participation.
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Diagnosis of and treatment for a secondary malignancy in the past 12 months.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboudumc | Nijmegen | Gelderland | Netherlands | 6500 HB |
| 2 | Netherlands Cancer Institute | Amsterdam | Noord-Holland | Netherlands | 1066 CX |
| 3 | VUmc | Amsterdam | Noord-Holland | Netherlands | 1081 HV |
| 4 | Leids Universitair Medisch Centrum | Leiden | Zuid-Holland | Netherlands | 2300 RC |
| 5 | Erasmus MC | Rotterdam | Zuid-Holland | Netherlands | 3000 CA |
| 6 | Haga ziekenhuis | Den Haag | Netherlands | 2545 CH | |
| 7 | Albert Schweitzer Ziekenhuis | Dordrecht | Netherlands | 3300 AK | |
| 8 | Admiraal de Ruyter ziekenhuis | Goes | Netherlands | 3318 AT | |
| 9 | Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | 2508 GA |
Sponsors and Collaborators
- The Netherlands Cancer Institute
- Dutch Cancer Society
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL61017.031.17