Lighting Intervention for Cancer-related Fatigue

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2023-03-09

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.

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Detailed Description

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Conditions

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Breast Cancer Prostate Cancer Hematologic Malignancy Survivorship Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Arm

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

Group Type EXPERIMENTAL

Wearable Sensor

Intervention Type OTHER

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

Blue-blocking glasses

Intervention Type OTHER

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

Full SYNC app

Intervention Type OTHER

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

Control Arm

Placebo light intervention delivered through SYNC app + clear glasses.

Group Type ACTIVE_COMPARATOR

Wearable Sensor

Intervention Type OTHER

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

Clear glasses

Intervention Type OTHER

Patient is given glasses that block no visible light.

"Dummy" SYNC app

Intervention Type OTHER

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

Interventions

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Wearable Sensor

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

Intervention Type OTHER

Blue-blocking glasses

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

Intervention Type OTHER

Clear glasses

Patient is given glasses that block no visible light.

Intervention Type OTHER

Full SYNC app

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

Intervention Type OTHER

"Dummy" SYNC app

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

Intervention Type OTHER

Other Intervention Names

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Apple Watch or Fitbit Charge 3

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No