Lighting Intervention for Cancer-related Fatigue

A Randomized Trial Of The SYNC APP

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04827446

Enrollment

139

Registered

2021-04-01

Start date

2021-07-15

Completion date

2023-03-09

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Prostate Cancer, Hematologic Malignancy, Survivorship, Fatigue

Keywords

Fatigue, light therapy, mobile app

Brief summary

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.

Interventions

OTHERWearable Sensor

Patient is given a wearable device to wear for 12 weeks.

OTHERBlue-blocking glasses

Patient is given blue-blocking glasses to wear at instructed times.

OTHERClear glasses

Patient is given glasses that block no visible light.

OTHERFull SYNC app

Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.

OTHERDummy SYNC app

Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Intervention model description

Blocked randomization will be used to limit bias and achieve an equal distribution of participants to the intervention and control arms of the study (69 control, 69 intervention; with 23 from each cancer population in each arm). This approach will recruit participants in small blocks to ensure that half of the participants within each block will be allocated to the treatment and the other half to the control.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8a	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.
Change in Level of Anxiety Using PROMIS SF Anxiety 7a	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.
Change in Level of Depression Using PROMIS SF Depression 8a	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
Change in Level of Physical Function Using PROMIS SF Physical Function 8b	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
Change in Overall Health Metrics Using PROMIS Global-10	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	65
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.	66
Total	131

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	2	0
Overall Study	Lost to Follow-up	1	1
Overall Study	Withdrawal by Subject	2	2

Baseline characteristics

Characteristic	Intervention Arm	Control Arm	Total
Age, Customized Breast	52.09 years	57 years	54.55 years
Age, Customized HSCT	54.95 years	53.91 years	54.43 years
Age, Customized Prostate	70.24 years	67.24 years	68.74 years
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	0 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants	64 Participants	124 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Black or African American	2 Participants	5 Participants	7 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	1 Participants	3 Participants
Race (NIH/OMB) White	60 Participants	59 Participants	119 Participants
Region of Enrollment United States	65 participants	66 participants	131 participants
Sex: Female, Male Female	35 Participants	35 Participants	70 Participants
Sex: Female, Male Male	30 Participants	31 Participants	61 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 65	4 / 66
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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).

Time frame: 11 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Intervention Arm	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
Intervention Arm	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
Control Arm	Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a	Week 1 fatigue T-scores	2.03 score on a scale	Standard Deviation 0.53
Control Arm	Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a	Week 11 fatigue T-scores	1.58 score on a scale	Standard Deviation 0.61

Secondary

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.