Breast CancerNCT04827446
Lighting Intervention for Cancer-related Fatigue
A study testing Wearable Sensor, Blue-blocking glasses and Clear glasses in people with Breast Cancer and Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Hematologic Malignancy
- What is being tested?
- Wearable Sensor, Blue-blocking glasses and Clear glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 9 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: A Randomized Trial Of The SYNC APP
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
- Being tested
- Wearable Sensor, Blue-blocking glasses, Clear glasses, Full SYNC app, "Dummy" SYNC app
- Keywords
- Fatigue, light therapy, mobile app
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Hematologic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable SensorOther
Also called Apple Watch or Fitbit Charge 3
Patient is given a wearable device to wear for 12 weeks.
Blue-blocking glassesOther
Patient is given blue-blocking glasses to wear at instructed times.
Clear glassesOther
Patient is given glasses that block no visible light.
Full SYNC appOther
Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
"Dummy" SYNC appOther
Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Light intervention delivered through SYNC app + blue-light blocking glasses. Receives: Other: Wearable Sensor; Other: Blue-blocking glasses; Other: Full SYNC app |
| Control Arm | Active comparator | Placebo light intervention delivered through SYNC app + clear glasses. Receives: Other: Wearable Sensor; Other: Clear glasses; Other: "Dummy" SYNC app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 11 weeks
Secondary outcomes (5)
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.
Measured: baseline to 12 weeks
Change in Level of Anxiety Using PROMIS SF Anxiety 7a
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). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates greater anxiety levels. The T-Score metric is used to convert the raw score to a standard score and the range is around 36-74 with a mean score around 50.
Measured: baseline to 12 weeks
Change in Level of Depression Using PROMIS SF Depression 8a
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). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates greater severity of depression. The T-Score metric is used to convert the raw score to a standard score and a typical range is around 40-60. T-scores are standardized, with a mean of 50 and a standard deviation of 10
Measured: baseline to 12 weeks
Change in Level of Physical Function Using PROMIS SF Physical Function 8b
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). Mean scores are to be compared between the pre-trial and post-trial assessments. A higher score indicates better physical function. The T-Score metric is used to convert the raw score to a standard score. The T-score has a mean of 50 and a standard deviation of 10
Measured: baseline to 12 weeks
Change in Overall Health Metrics Using PROMIS Global-10
PROMIS Global-10 is a 10-question survey used as an overall evaluation of one's physical and mental health. Mean scores are to be compared between the pre-trial and post-trial assessments for both physical and mental health. A higher score indicates better overall health. The T-Score metric is used to convert the raw score to a standard score and a typical range is 0-100. The T-score has a mean of 50 and a standard deviation of 10
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start15 Jul 2021
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arcascope, Inc, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sung Choi, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827446
- Sponsor's protocol ID
- UMCC 2020.157
- Other IDs
- HUM00191617, R44CA236557
- Status last verified
- Jun 2025
- First submitted
- 29 Mar 2021
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40056908
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Of The SYNC APP
- ClinicalTrials.gov ID
- NCT04827446
- Acronym / sponsor ID
- UMCC 2020.157
- Conditions
- Breast Cancer, Prostate Cancer, Hematologic Malignancy, Survivorship, Fatigue
- Keywords
- Fatigue, light therapy, mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Arcascope, Inc, National Cancer Institute (NCI)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 9 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Wearable Sensor, Other: Blue-blocking glasses, Other: Full SYNC appLight intervention delivered through SYNC app + blue-light blocking glasses. |
| Control Arm | Active comparator | Other: Wearable Sensor, Other: Clear glasses, Other: "Dummy" SYNC appPlacebo light intervention delivered through SYNC app + clear glasses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable SensorAlso: Apple Watch or Fitbit Charge 3Patient is given a wearable device to wear for 12 weeks. | Other | Control Arm, Intervention Arm |
| Blue-blocking glassesPatient is given blue-blocking glasses to wear at instructed times. | Other | Intervention Arm |
| Clear glassesPatient is given glasses that block no visible light. | Other | Control Arm |
| Full SYNC appPatient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock. | Other | Intervention Arm |
| "Dummy" SYNC appPatient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock. | Other | Control Arm |
Primary outcome
Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a
Time frame: 11 weeks
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).
5 secondary outcomes
Change in Level of Sleep Disturbance Using PROMIS SF Sleep Disturbance 8a
Time frame: baseline to 12 weeks
Change in Level of Anxiety Using PROMIS SF Anxiety 7a
Time frame: baseline to 12 weeks
Change in Level of Depression Using PROMIS SF Depression 8a
Time frame: baseline to 12 weeks
Change in Level of Physical Function Using PROMIS SF Physical Function 8b
Time frame: baseline to 12 weeks
Change in Overall Health Metrics Using PROMIS Global-10
Time frame: baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40056908Mayer 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Choi, MD principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Sensor, Blue-blocking glasses and Clear glasses in people with Breast Cancer and Prostate Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Assessed With Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.