Self-reported Stress Perception in Breast Cancer Patients Treated with Integrative Metal Color Light Therapy: The LUCIA Study Protocol
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Introduction
Many breast cancer patients benefit from appropriate oncological therapies, but also experience side effects or ongoing restrictions that have a significant impact on health-related quality of life. Non-Pharmaceutical Interventions (NPIs) such as sport, movement, art therapy, yoga or mindfulness-based stress reduction, can help to reduce distress and pain and support resilience strategies. Metal Colored Light (MCL) therapy, an integrative art therapy using metal colored glasses, has been used in the past to relieve symptoms, improve quality of life and support coping strategies. The LUCIA study aims for the first time to systematically investigate whether self-reported perception of stress can be influenced in breast cancer patients through a series of MCL.
Methods and analysis
The LUCIA-study will enroll 60 breast cancer patients treated with MCL therapy, which consists of nine individual MCL sessions per patient over a six-week period. The primary outcome is the analysis of self-reported stress perception of breast cancer patients using the National Comprehensive Cancer Network (NCCN) Distress Thermometer. Secondary endpoints include the Internal Coherence Scale (ICS) and quality of life using the European Organization for Research and Treatment of Cancer Questionnaire C30 (EORTC-QLQ-C30). Longitudinal changes in symptom burden will be assessed and multivariate analyses performed.
Ethics and disseminations
The present study is approved by the ethics committee of the Medical Association Berlin within the Network Oncology with the reference number Eth-27/10. The results will be presented at scientific conferences and published.
Trial registration number
The study was registered at the German Register for Clinical Trials under DRKS00013335 on 27/11/2017.
Strengths and limitations of this study
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Self-reported stress perception of each participant in this LUCIA study will be evaluated before (T0) and after the Metal Colored Light (MCL) therapy (T1).
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Changes in self-reported distress burden, internal coherence and health-related quality of life will be followed and asked three months (T2) and six months (T3) after T0.
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Prospective evaluation of all participants.
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Sources of bias and potential confounding can be limited through the use of multivariate analyses.
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There is no direct control or placebo group and no blinding.