Lighting Intervention for Cancer-related Fatigue

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial Of The SYNC APP

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

Intervention / Treatment
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* Other: Wearable Sensor
* Other: Blue-blocking glasses
* Other: Clear glasses
* Other: Full SYNC app
* Other: Dummy SYNC app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 change from baseline in PROMIS 4-item Fatigue scores will enable the investigators to quantify the effects of the light interventions delivered by SYNC on patient fatigue. The final fatigue score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10 points. The average change in PROMIS fatigue T scores will be calculated for each arm. A negative change (lower scores) represents improvement in symptoms; a positive change (higher scores) represents worsening of symptoms. The study will have power of 0.80, assuming a two-sided Type I error rate of 0.05, to detect an effect size of half the standard deviation between the intervention and control arms if the accrual goal is reached. | baseline, weekly to 12 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). | 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). | 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). | 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). | 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. Raw scores are converted to T-scores. Higher scores reflect better functioning. | baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, light therapy, mobile app