This clinical trial studies the effect of a mobile application (app) in reducing fatigue in patients with breast cancer, prostate cancer, or blood cancer. Fatigue is extremely common among cancer patients and survivors, and it can negatively impact quality of life, mood, and overall health and well-being. Fatigue can be difficult to treat, and there is currently no gold-standard treatment for fatigue. This study aims to see whether light exposure and behavioral changes may improve circadian rhythms and reduce cancer-related fatigue.
Additional locations may be listed on ClinicalTrials.gov for NCT04827446.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To test the difference between the intervention (full SYNC app) arm and the control (limited SYNC app) arm in the measured outcome of patient fatigue, assessed by daily 1 question surveys and weekly 4 item Patient Reported Outcomes Measurement Information System (PROMIS) questionnaires over the course of 12 weeks.
SECONDARY OBJECTIVE:
I. To determine the change in sleep disturbances, anxiety, depression, physical functioning, and global health through PROMIS questionnaires, between baseline and the 12 week assessment in both the control and intervention arms, and to look for differences in this change between the two arms.
EXPLORATORY OBJECTIVES:
I. Change in patient physical activity through physiological data capture using the wearable sensors in the control versus intervention arm.
II. Change in patient health care utilization (e. total count of hospital days, readmissions, and ambulatory care clinic visits) in the control versus intervention arm.
III. Change in patient sleep aid usage in the control versus intervention arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear sensor device, use blue-blocking glasses, and have access to full SYNC app for 12 weeks.
ARM II: Patients wear sensor device, use clear glasses, and have access to dummy SYNC app for 12 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Michigan Comprehensive Cancer Center
Principal InvestigatorSung Won Choi