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

Phase 3

Recruiting

• Conditions: 10040991; weariness; vermoeidheid; tiredness; 10025319

• Registration Number: NL-OMON47562
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter in this study is the change in cancer related fatigue<br /><br>from baseline to post-intervention and at 3 and 9 months follow-up. This will<br /><br>be assessed with the Multidimensional Fatigue Inventory. </p><br>

Secondary Outcome Measures

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