Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Blood and Lymph Conditions

Prostatic Neoplasms

Breast Neoplasms

Fatigue

Hematologic Neoplasms

Hematologic Diseases

Central Nervous System Stimulants

All Drugs and Chemicals

Cardiotonic Agents

Methamphetamine

Sympathomimetics

Dopamine

Dopamine Agents

Neurotransmitter Agents

Adrenergic Agents

Dopamine Uptake Inhibitors

Light intervention delivered through SYNC app + blue-light blocking glasses.

Placebo light intervention delivered through SYNC app + clear glasses.

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

Wearable Sensor

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

Blue-blocking glasses

Patient is given glasses that block no visible light.

Clear glasses

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

Full SYNC app

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

"Dummy" SYNC app

Sung Choi, MD

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.

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.

Lighting Intervention for Cancer-related Fatigue

A Randomized Trial Of The SYNC APP

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.

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).

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).

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).

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center
Lighting Intervention for Cancer-related Fatigue	NCT04827446	Breast Cancer Prostate Cancer Hematologic Mal... Survivorship Fatigue	Wearable Sensor Blue-blocking g... Clear glasses Full SYNC app "Dummy" SYNC ap...	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for "dummy" sync app