18 and older, any sex, with Breast Cancer or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4aPrimary· 11 weeks
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 f
Week 1 fatigue T-scores
Group
Value
95% CI
Intervention Arm
2.18
± 0.68
Control Arm
2.03
± 0.53
Week 11 fatigue T-scores
Group
Value
95% CI
Intervention Arm
1.70
± 0.74
Control Arm
1.58
± 0.61
Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8aSecondary· baseline to 12 weeks
8-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.
Pre-trial
Group
Value
95% CI
Intervention Arm
55.84
± 6.81
Control Arm
53.71
± 6.29
Post- Trial
Group
Value
95% CI
Intervention Arm
51.85
± 6.31
Control Arm
52.06
± 6.03
Change in Level of Anxiety Using PROMIS SF Anxiety 7aSecondary· baseline to 12 weeks
7-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.
Pre-trial
Group
Value
95% CI
Intervention Arm
53.16
± 9.06
Control Arm
51.71
± 7.73
Post-trial
Group
Value
95% CI
Intervention Arm
50.54
± 8.98
Control Arm
50.93
± 7.17
Change in Level of Depression Using PROMIS SF Depression 8aSecondary· baseline to 12 weeks
8-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
Pre-trial
Group
Value
95% CI
Intervention Arm
50.94
± 7.55
Control Arm
49.90
± 6.76
Post-trial
Group
Value
95% CI
Intervention Arm
49.25
± 8.25
Control Arm
48.03
± 6.75
Change in Level of Physical Function Using PROMIS SF Physical Function 8bSecondary· baseline to 12 weeks
8-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
Pre-Trial
Group
Value
95% CI
Intervention Arm
43.25
± 8.20
Control Arm
45.07
± 8.03
Post- Trial
Group
Value
95% CI
Intervention Arm
44.66
± 8.31
Control Arm
46.40
± 7.71
Change in Overall Health Metrics Using PROMIS Global-10Secondary· baseline to 12 weeks
PROMIS 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
Pre-trial Physical Health
Group
Value
95% CI
Intervention Arm
41.67
± 5.66
Control Arm
42.82
± 4.45
Post-trial Physical Health
Group
Value
95% CI
Intervention Arm
42.96
± 5.76
Control Arm
44.16
± 4.81
Pre-trial Mental Health
Group
Value
95% CI
Intervention Arm
46.24
± 7.45
Control Arm
47.61
± 6.37
Post-trial Mental Health
Group
Value
95% CI
Intervention Arm
47.31
± 8.06
Control Arm
47.38
± 6.51
Sponsor's own description
Fatigue is a major problem for cancer patients, and one that can persist long after treatment ends. Recent work has demonstrated that light therapy may mitigate or reduce fatigue levels in both cancer patients and cancer survivors. This protocol seeks to assess how lighting interventions distributed through a mobile app affect fatigue, sleep, and quality of life across three populations of cancer patients: breast cancer and prostate cancer, and patients who have undergone autologous hematopoietic stem cell transplant (HSCT). Participants will be randomized 1:1 to either the interventional SYNC app or to a control app.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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· NA
· unknown
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· NA
· completed
NCT03475485 — ID-Cap System Under Direct Observation
· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Michigan Rogel Cancer Center
Last refreshed: 9 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04827446.