Clinical trial NCT04827446: Lighting Intervention for Cancer-related Fatigue
Official title: A Randomized Trial Of The SYNC APP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Hematologic Malignancy
Survivorship
Fatigue
Keywords: Fatigue
light therapy
mobile app
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Arcascope, Inc
name: National Cancer Institute (NCI)
First posted: 2021-04-01
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change in fatigue assessed with Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a
timeFrame: baseline, weekly to 12 weeks
Secondary outcomes:
measure: Change in level of sleep disturbance using PROMIS SF Sleep Disturbance 8a
timeFrame: baseline to 12 weeks
measure: Change in level of anxiety using PROMIS SF Anxiety 7a
timeFrame: baseline to 12 weeks
measure: Change in level of depression using PROMIS SF Depression 8a
timeFrame: baseline to 12 weeks
measure: Change in level of physical function using PROMIS SF Physical Function 8b
timeFrame: baseline to 12 weeks
measure: Change in overall health metrics using PROMIS Global-10
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Sung Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: