Lighting Intervention for Cancer-related Fatigue

A Randomized Trial Of The SYNC APP

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Fatigue; Prostate Cancer; Hematologic Malignancy; Survivorship
• Intervention / Treatment: Other: Wearable Sensor; Other: Blue-blocking glasses; Other: Full SYNC app; Other: Clear glasses; Other: "Dummy" SYNC app

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Must own an iPhone 6s or later (with iOS 14 or later or willing to update to iOS 14+) and be willing to complete surveys on it, per the protocol.
• Sleep aid usage will be allowed as long as the patient has been on a stable dose for at least 4 weeks prior to enrollment and agrees to continue the same dose during the study.
• A response of at least 4 on a 10 point scale (with 0 = not fatigued at all and 10 = extremely fatigued) to the question "How fatigued did you feel in the past week?"
• Breast cancer population: Diagnosed with stage 1-3 breast cancer in the last 10 years, without metastatic disease. Chemotherapy or radiation therapy, if indicated, must have been completed at least 3 months prior to enrollment. Concomitant anti-HER2 therapy and/or anti-endocrine therapy is permitted.
• Prostate cancer population: Undergoing androgen deprivation therapy (ADT) for at least three months and are anticipated to remain on ADT for the duration of the trial. Concomitant additional anti-androgen therapy (e.g., enzalutamide) is permitted.
• Autologous HSCT population: Participants must be from the University of Michigan Blood and Marrow Transplant Program.

Exclusion Criteria

• The patient cannot be undergoing chemotherapy at the time of enrollment, but post transplant maintenance therapy that begins after enrollment is allowed.
• The patient must have no evidence of disease progression or recurrence. Specifically for the prostate cancer population, the patient must have no evidence of disease progression on their current ADT regimen at the time of enrollment.
• The patient must not be a night shift worker, where night shift is defined as working a significant number of hours (i.e. more than half) between the hours of 11PM and 6AM on a regular basis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Light intervention delivered through SYNC app + blue-light blocking glasses.	Other: Wearable Sensor; Patient is given a wearable device to wear for 12 weeks.; Other Names: Apple Watch or Fitbit Charge 3; Other: Blue-blocking glasses; Patient is given blue-blocking glasses to wear at instructed times.; Other: Full SYNC app; Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
Active Comparator: Control Arm; Placebo light intervention delivered through SYNC app + clear glasses.	Other: Wearable Sensor; Patient is given a wearable device to wear for 12 weeks.; Other Names: Apple Watch or Fitbit Charge 3; Other: Clear glasses; Patient is given glasses that block no visible light.; Other: "Dummy" SYNC app; Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a	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).	11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8a	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.	baseline to 12 weeks
Change in Level of Anxiety Using PROMIS SF Anxiety 7a	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.	baseline to 12 weeks
Change in Level of Depression Using PROMIS SF Depression 8a	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	baseline to 12 weeks
Change in Level of Physical Function Using PROMIS SF Physical Function 8b	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	baseline to 12 weeks
Change in Overall Health Metrics Using PROMIS Global-10	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	baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Cancer Institute (NCI); Arcascope, Inc
• Investigators: Principal Investigator: Sung Choi, MD, University of Michigan Rogel Cancer Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Fatigue; light therapy; mobile app
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hematologic Neoplasms; Fatigue; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Adrenergic Agents; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Adrenergic Uptake Inhibitors; Sympathomimetics; Methamphetamine
• Other Study ID Numbers: UMCC 2020.157; HUM00191617 (Other Identifier: UM IRB); R44CA236557 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No