Lighting Intervention for Cancer-related Fatigue

NCT04827446 | Completed Results

• 3 other identifiers: UMCC 2020.157HUM00191617R44CA236557
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Prostate Cancer; Hematologic Malignancy; Survivorship; Fatigue

Keywords

Fatigue; light therapy; mobile app

Outcome Measures

Primary Outcomes (1)

• 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).

  11 weeks

Secondary Outcomes (5)

• Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8a

  baseline to 12 weeks

• Change in Level of Anxiety Using PROMIS SF Anxiety 7a

  baseline to 12 weeks

• Change in Level of Depression Using PROMIS SF Depression 8a

  baseline to 12 weeks

• Change in Level of Physical Function Using PROMIS SF Physical Function 8b

  baseline to 12 weeks

• Change in Overall Health Metrics Using PROMIS Global-10

  baseline to 12 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Other: Wearable Sensor; Other: Blue-blocking glasses; Other: Full SYNC app

Control Arm

ACTIVE COMPARATOR

Placebo light intervention delivered through SYNC app + clear glasses.

Other: Wearable Sensor; Other: Clear glasses; Other: "Dummy" SYNC app

Interventions

Wearable Sensor OTHER

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

Also known as: Apple Watch or Fitbit Charge 3

Control Arm; Intervention Arm

Blue-blocking glasses OTHER

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

Intervention Arm

Clear glasses OTHER

Patient is given glasses that block no visible light.

Control Arm

Full SYNC app OTHER

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

Intervention Arm

"Dummy" SYNC app OTHER

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

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Arcascope, Inc: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Mayer C, Walch O, Dempsey W, Hannay K, Clingan C, Bowen Z, Rozwadowski M, Reichert ZR, Henry NL, Alumkal JJ, Tewari M, Forger DB, Choi SW. A circadian and app-based personalized lighting intervention for the reduction of cancer-related fatigue. Cell Rep Med. 2025 Mar 18;6(3):102001. doi: 10.1016/j.xcrm.2025.102001. Epub 2025 Mar 7.

  PMID: 40056908 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Hematologic Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
• Organization: University of Michigan Rogel Cancer Center

ClinicalTrialsgov_CCAdmin@umich.edu

734-936-9499

Study Officials

• Sung Choi, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: July 15, 2021
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2023
• Last Updated: July 9, 2025
• Results First Posted: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)