Trial Outcomes & Findings for Lighting Intervention for Cancer-related Fatigue (NCT NCT04827446)
NCT ID: NCT04827446
Last Updated: 2025-07-09
Results Overview
The primary outcome was PROMIS® Fatigue 4a Short Form (SF) at the end of trial, compared between arms. As we did not have a PROMIS® 4-item Fatigue weekly measurement for week 0, we were unable to calculate a change from baseline through this measure alone. We assessed this outcome by looking at differences in fatigue between the intervention and control group at the final week (week 11), and the treatment effect on fatigue at week 11 while controlling (through generalized estimating equations) for baseline fatigue with the 1-item Fatigue question ("In the past 7 days, how would you rate your fatigue on average?") taken from the pre-trial PROMIS® Global Health survey. The 1-item question about fatigue on the pre and post-trial Global Health surveys was scored on a scale from 0 (least fatigued) to 4 (most fatigued).
COMPLETED
NA
139 participants
11 weeks
2025-07-09
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
|
Overall Study
COMPLETED
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Intervention Arm
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Separated by arm and cancer population
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=65 Participants
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
n=66 Participants
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Breast
|
52.09 years
n=23 Participants • Separated by arm and cancer population
|
57 years
n=23 Participants • Separated by arm and cancer population
|
54.55 years
n=46 Participants • Separated by arm and cancer population
|
|
Age, Customized
Prostate
|
70.24 years
n=21 Participants • Separated by arm and cancer population
|
67.24 years
n=21 Participants • Separated by arm and cancer population
|
68.74 years
n=42 Participants • Separated by arm and cancer population
|
|
Age, Customized
HSCT
|
54.95 years
n=21 Participants • Separated by arm and cancer population
|
53.91 years
n=22 Participants • Separated by arm and cancer population
|
54.43 years
n=43 Participants • Separated by arm and cancer population
|
|
Sex: Female, Male
Female
|
35 Participants
n=65 Participants
|
35 Participants
n=66 Participants
|
70 Participants
n=131 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=65 Participants
|
31 Participants
n=66 Participants
|
61 Participants
n=131 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=65 Participants
|
0 Participants
n=66 Participants
|
4 Participants
n=131 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=65 Participants
|
64 Participants
n=66 Participants
|
124 Participants
n=131 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=65 Participants
|
2 Participants
n=66 Participants
|
3 Participants
n=131 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=65 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=65 Participants
|
1 Participants
n=66 Participants
|
2 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=65 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=65 Participants
|
5 Participants
n=66 Participants
|
7 Participants
n=131 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=65 Participants
|
59 Participants
n=66 Participants
|
119 Participants
n=131 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=65 Participants
|
0 Participants
n=66 Participants
|
0 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=65 Participants
|
1 Participants
n=66 Participants
|
3 Participants
n=131 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=65 Participants
|
66 participants
n=66 Participants
|
131 participants
n=131 Participants
|
PRIMARY outcome
Timeframe: 11 weeksThe primary outcome was PROMIS® Fatigue 4a Short Form (SF) at the end of trial, compared between arms. As we did not have a PROMIS® 4-item Fatigue weekly measurement for week 0, we were unable to calculate a change from baseline through this measure alone. We assessed this outcome by looking at differences in fatigue between the intervention and control group at the final week (week 11), and the treatment effect on fatigue at week 11 while controlling (through generalized estimating equations) for baseline fatigue with the 1-item Fatigue question ("In the past 7 days, how would you rate your fatigue on average?") taken from the pre-trial PROMIS® Global Health survey. The 1-item question about fatigue on the pre and post-trial Global Health surveys was scored on a scale from 0 (least fatigued) to 4 (most fatigued).
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
n=66 Participants
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a
Week 1 fatigue T-scores
|
2.18 score on a scale
Standard Deviation 0.68
|
2.03 score on a scale
Standard Deviation 0.53
|
|
Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a
Week 11 fatigue T-scores
|
1.70 score on a scale
Standard Deviation 0.74
|
1.58 score on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: baseline to 12 weeks8-item PROMIS sleep disturbance questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates more severe sleep disturbance. The T-Score metric is used to convert the raw score to a standard score, the T-score represents a standardized measure of sleep disturbance, with a mean of 50 and a standard deviation of 10.
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
n=66 Participants
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8a
Pre-trial
|
55.84 T Score
Standard Deviation 6.81
|
53.71 T Score
Standard Deviation 6.29
|
|
Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8a
Post- Trial
|
51.85 T Score
Standard Deviation 6.31
|
52.06 T Score
Standard Deviation 6.03
|
SECONDARY outcome
Timeframe: baseline to 12 weeks7-item PROMIS anxiety questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates greater anxiety levels. The T-Score metric is used to convert the raw score to a standard score and the range is around 36-74 with a mean score around 50.
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
n=66 Participants
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Change in Level of Anxiety Using PROMIS SF Anxiety 7a
Pre-trial
|
53.16 T Score
Standard Deviation 9.06
|
51.71 T Score
Standard Deviation 7.73
|
|
Change in Level of Anxiety Using PROMIS SF Anxiety 7a
Post-trial
|
50.54 T Score
Standard Deviation 8.98
|
50.93 T Score
Standard Deviation 7.17
|
SECONDARY outcome
Timeframe: baseline to 12 weeks8-item PROMIS depression questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates greater severity of depression. The T-Score metric is used to convert the raw score to a standard score and a typical range is around 40-60. T-scores are standardized, with a mean of 50 and a standard deviation of 10
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
n=66 Participants
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Change in Level of Depression Using PROMIS SF Depression 8a
Pre-trial
|
50.94 T Score
Standard Deviation 7.55
|
49.90 T Score
Standard Deviation 6.76
|
|
Change in Level of Depression Using PROMIS SF Depression 8a
Post-trial
|
49.25 T Score
Standard Deviation 8.25
|
48.03 T Score
Standard Deviation 6.75
|
SECONDARY outcome
Timeframe: baseline to 12 weeks8-item PROMIS physical function questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates better physical function. The T-Score metric is used to convert the raw score to a standard score. The T-score has a mean of 50 and a standard deviation of 10
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
n=66 Participants
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Change in Level of Physical Function Using PROMIS SF Physical Function 8b
Pre-Trial
|
43.25 T Score
Standard Deviation 8.20
|
45.07 T Score
Standard Deviation 8.03
|
|
Change in Level of Physical Function Using PROMIS SF Physical Function 8b
Post- Trial
|
44.66 T Score
Standard Deviation 8.31
|
46.40 T Score
Standard Deviation 7.71
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPROMIS Global-10 is a 10-question survey used as an overall evaluation of one's physical and mental health. Mean scores are to be compared between the pre-trial and post-trial assessments for both physical and mental health. A higher score indicates better overall health. The T-Score metric is used to convert the raw score to a standard score and a typical range is 0-100. The T-score has a mean of 50 and a standard deviation of 10
Outcome measures
| Measure |
Intervention Arm
n=65 Participants
Light intervention delivered through SYNC app + blue-light blocking glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times.
Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
|
Control Arm
n=66 Participants
Placebo light intervention delivered through SYNC app + clear glasses.
Wearable Sensor: Patient is given a wearable device to wear for 12 weeks.
Clear glasses: Patient is given glasses that block no visible light.
"Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
|
|---|---|---|
|
Change in Overall Health Metrics Using PROMIS Global-10
Pre-trial Physical Health
|
41.67 T Score
Standard Deviation 5.66
|
42.82 T Score
Standard Deviation 4.45
|
|
Change in Overall Health Metrics Using PROMIS Global-10
Post-trial Physical Health
|
42.96 T Score
Standard Deviation 5.76
|
44.16 T Score
Standard Deviation 4.81
|
|
Change in Overall Health Metrics Using PROMIS Global-10
Pre-trial Mental Health
|
46.24 T Score
Standard Deviation 7.45
|
47.61 T Score
Standard Deviation 6.37
|
|
Change in Overall Health Metrics Using PROMIS Global-10
Post-trial Mental Health
|
47.31 T Score
Standard Deviation 8.06
|
47.38 T Score
Standard Deviation 6.51
|
Adverse Events
Intervention Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place