Trial results for a lighting intervention study targeting cancer-related fatigue, including patients with Breast Cancer, were posted on ClinicalTrials.gov on 2025-07-09, with 139 participants enrolled.
Background
Fatigue is a significant and persistent issue for cancer patients and survivors, often continuing long after active treatment concludes. This symptom can profoundly impact quality of life. Recent research has suggested that light therapy could potentially help reduce or alleviate fatigue levels in these populations. The trial aimed to investigate the effects of lighting interventions, delivered via a mobile app, on fatigue, sleep, and overall quality of life across several cancer patient groups.
Trial design
This completed study, designated as Phase NA, enrolled 139 participants. The trial investigated lighting interventions for patients with conditions including Breast Cancer, Prostate Cancer, Hematologic Malignancy, Survivorship, and general Fatigue. Participants were randomized 1:1 to either an interventional SYNC arm, which involved lighting interventions delivered via a mobile app, or a control arm. The study aimed to assess the impact of these interventions on fatigue, sleep, and quality of life.
Key results
The trial collected several key measurements related to patient-reported outcomes:
- Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a (score on a scale):
- For the Intervention Arm, a mean of 2.18 (Standard Deviation 0.68) was observed.
- For the Control Arm, a mean of 2.03 (Standard Deviation 0.53) was observed.
- In another measurement, the Intervention Arm showed a mean of 1.70 (Standard Deviation 0.74).
- The Control Arm showed a mean of 1.58 (Standard Deviation 0.61).
- Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8a (T Score):
- For the Intervention Arm, a mean of 55.84 (Standard Deviation 6.81) was observed.
- For the Control Arm, a mean of 53.71 (Standard Deviation 6.29) was observed.
- In another measurement, the Intervention Arm showed a mean of 51.85 (Standard Deviation 6.31).
- The Control Arm showed a mean of 52.06 (Standard Deviation 6.03).
- Change in Level of Anxiety Using PROMIS SF Anxiety 7a (T Score):
- For the Intervention Arm, a mean of 53.16 (Standard Deviation 9.06) was observed.
- For the Control Arm, a mean of 51.71 (Standard Deviation 7.73) was observed.
- In another measurement, the Intervention Arm showed a mean of 50.54 (Standard Deviation 8.98).
- The Control Arm showed a mean of 50.93 (Standard Deviation 7.17).
What this means
The posted results provide specific mean values and standard deviations for changes in fatigue, sleep disturbance, and anxiety levels in both the intervention and control arms. These measurements contribute to understanding the observed outcomes of the lighting intervention in cancer patients. Without further statistical analyses or context on the clinical significance of these score changes, definitive conclusions about the intervention's efficacy or the direction of its effect cannot be drawn from the provided data alone. The findings offer initial data for further research into lighting interventions for cancer-related symptoms.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04827446, titled 'Lighting Intervention for Cancer-related Fatigue', were posted on 2025-07-09 on clinicaltrials.gov.