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Improving sleep quality, psychosocial functioning, and cancer related fatigue with light therapy (SPARKLE-study).

Improving sleep quality, psychosocial functioning, and cancer related fatigue with light therapy (SPARKLE-study). - To decrease fatigue with light therapy (SPARKLE-study).

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47562
Enrollment
160
Registered
2018-09-27
Start date
2017-07-20
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vermoeidheid tiredness weariness

Interventions

The light intervention includes exposure to bright 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 do
cancer related fatigue
circadian rhythm
light therapy

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (Non-)Hodgkin lymphoma survivors (survivorship of min. 2 years) with moderate to severe fatigue symptoms; or survivors with moderate to severe restrictions on work and social activities to avoid clinical levels of fatigue.

Exclusion criteria

Exclusion criteria: Fatigue is explained by a somatic factor as defined in the guidelines of chronic fatigue syndrome of the Dutch internists association; or fatigue is explained by the treatment of (treatment for) secondary cancer in the past 12 months.

Design outcomes

Primary

MeasureTime frame
The main study parameter in this study is the change in cancer related fatigue from baseline to post-intervention and at 3 and 9 months follow-up. This will be assessed with the Multidimensional Fatigue Inventory.

Secondary

MeasureTime frame
Secundary study parameters include the following psychological variables: sleep quality, depression, anxiety, quality of life, cognitive complaints, cancer worries, fatigue catastrophizing, and self-efficacy to manage with fatigue complaints. Moreover, biological levels of cortisol and melatonin will be measured in saliva. Blood samples will be used to assess vitamin D, hsIL-6, sTNF-RII, IL-1RA, hsCRP, and genotype.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)