Lighting Intervention for Cancer-related Fatigue

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT04827446
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wearable Sensor — OTHER
    Patient is given a wearable device to wear for 12 weeks.
  • Blue-blocking glasses — OTHER
    Patient is given blue-blocking glasses to wear at instructed times.
  • Clear glasses — OTHER
    Patient is given glasses that block no visible light.
  • Full SYNC app — OTHER
    Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
  • "Dummy" SYNC app — OTHER
    Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.

Study Details

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.

Key Dates

Start date
Jul 15, 2021
Status verified
Jun 2025
Primary completion
Mar 9, 2023
Completion
Mar 9, 2023

Study Design

Enrollment
139 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Arm
    Light intervention delivered through SYNC app + blue-light blocking glasses.
  • Active Comparator: Control Arm
    Placebo light intervention delivered through SYNC app + clear glasses.

Primary Outcome Measure

Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a [ Time Frame: 11 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-

Find similar trials in Ann Arbor, MI

By condition
Breast cancerProstate cancer
By specialty
OncologyBreast oncologyWomen's healthProstate oncologyMen's healthUrology
By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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