Lighting Intervention for Cancer-related Fatigue

Not Applicable

Completed

• Conditions: Breast Cancer; Prostate Cancer; Fatigue; Hematologic Malignancy; Survivorship
• Interventions: Other: Wearable Sensor; Other: Blue-blocking glasses; Other: Clear glasses; Other: "Dummy" SYNC app; Other: Full SYNC app

• Registration Number: NCT04827446
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-07-15
• Primary Completion: 2023-03-09
• Study Completion: 2023-03-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Wearable Sensor	Placebo light intervention delivered through SYNC app + clear glasses.
Control Arm	"Dummy" SYNC app	Placebo light intervention delivered through SYNC app + clear glasses.
Intervention Arm	Wearable Sensor	Light intervention delivered through SYNC app + blue-light blocking glasses.
Intervention Arm	Blue-blocking glasses	Light intervention delivered through SYNC app + blue-light blocking glasses.
Intervention Arm	Full SYNC app	Light intervention delivered through SYNC app + blue-light blocking glasses.
Control Arm	Clear glasses	Placebo light intervention delivered through SYNC app + clear glasses.

Primary Outcome Measures

Name	Time	Method
Change in fatigue assessed with Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a	baseline, weekly to 12 weeks	The change from baseline in PROMIS 4-item Fatigue scores will enable the investigators to quantify the effects of the light interventions delivered by SYNC on patient fatigue. The final fatigue score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10 points. The average change in PROMIS fatigue T scores will be calculated for each arm. A negative change (lower scores) represents improvement in symptoms; a positive change (higher scores) represents worsening of symptoms. The study will have power of 0.80, assuming a two-sided Type I error rate of 0.05, to detect an effect size of half the standard deviation between the intervention and control arms if the accrual goal is reached.

Secondary Outcome Measures

Name	Time	Method
Change in level of anxiety using PROMIS SF Anxiety 7a	baseline to 12 weeks	7-item PROMIS anxiety 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).
Change in level of depression using PROMIS SF Depression 8a	baseline to 12 weeks	8-item PROMIS depression 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).
Change in level of physical function using PROMIS SF Physical Function 8b	baseline to 12 weeks	8-item PROMIS physical function 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).
Change in level of sleep disturbance using PROMIS SF Sleep Disturbance 8a	baseline to 12 weeks	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).
Change in overall health metrics using PROMIS Global-10	baseline to 12 weeks	PROMIS Global-10 is a 10-question survey used as an overall evaluation of one's physical and mental health. Raw scores are converted to T-scores. Higher scores reflect better functioning.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States