Lighting Intervention for Cancer-related Fatigue

University of Michigan Rogel Cancer Center139 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

139

Conditions

Breast Cancer Prostate Cancer Hematologic Malignancy Survivorship Fatigue

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a

The primary outcome was PROMIS® Fatigue 4a Short Form (SF) at the end of trial, compared between arms. As we did not have a PROMIS® 4-item Fatigue weekly measurement for week 0, we were unable to calculate a change from baseline through this measure alone. We assessed this outcome by looking at differences in fatigue between the intervention and control group at the final week (week 11), and the treatment effect on fatigue at week 11 while controlling (through generalized estimating equations) for baseline fatigue with the 1-item Fatigue question ("In the past 7 days, how would you rate your fatigue on average?") taken from the pre-trial PROMIS® Global Health survey. The 1-item question about fatigue on the pre and post-trial Global Health surveys was scored on a scale from 0 (least fatigued) to 4 (most fatigued).

Time frame: 11 weeks

Secondary Outcomes

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). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates more severe sleep disturbance. The T-Score metric is used to convert the raw score to a standard score, the T-score represents a standardized measure of sleep disturbance, with a mean of 50 and a standard deviation of 10.