Lighting Intervention for Cancer-related Fatigue

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Hematologic Malignancy; Breast Cancer; Survivorship; Fatigue; Prostate Cancer

Treatments: Other: Wearable Sensor; Other: Clear glasses; Other: Full SYNC app; Other: "Dummy" SYNC app; Other: Blue-blocking glasses

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04827446

HUM00191617 (Other Identifier)

R44CA236557 (U.S. NIH Grant/Contract)

UMCC 2020.157

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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

Treatment:

Other: Blue-blocking glasses

Other: Full SYNC app

Other: Wearable Sensor

Control Arm

Active Comparator group

Description:

Placebo light intervention delivered through SYNC app + clear glasses.

Treatment:

Other: "Dummy" SYNC app

Other: Clear glasses

Other: Wearable Sensor