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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00191617 | Other Identifier | UM IRB | |
| R44CA236557 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Arcascope, Inc | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Light intervention delivered through SYNC app + blue-light blocking glasses. |
|
| Control Arm | Active Comparator | Placebo light intervention delivered through SYNC app + clear glasses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Sensor | Other | Patient is given a wearable device to wear for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sung Choi, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40056908 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Light intervention delivered through SYNC app + blue-light blocking glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times. Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock. |
| FG001 | Control Arm | Placebo light intervention delivered through SYNC app + clear glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Clear glasses: Patient is given glasses that block no visible light. "Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Light intervention delivered through SYNC app + blue-light blocking glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times. Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Separated by arm and cancer population |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 11 weeks |
|
Adverse Events and Serious Adverse Events were not collected as part of this trial. All Cause Mortality was assessed over a period of 2 years
Adverse Events and Serious Adverse Events were not collected as part of this trial. All Cause Mortality was assessed over a period of 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Light intervention delivered through SYNC app + blue-light blocking glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times. Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin | University of Michigan Rogel Cancer Center | 734-936-9499 | ClinicalTrialsgov_CCAdmin@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2022 | May 17, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2022 | Oct 23, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D019337 | Hematologic Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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| Blue-blocking glasses | Other | Patient is given blue-blocking glasses to wear at instructed times. |
|
| Clear glasses | Other | Patient is given glasses that block no visible light. |
|
| 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. |
|
| "Dummy" SYNC app | Other | Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock. |
|
| 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. | 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 | 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 | 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 | baseline to 12 weeks |
| Withdrawal by Subject |
|
| BG001 | Control Arm | Placebo light intervention delivered through SYNC app + clear glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Clear glasses: Patient is given glasses that block no visible light. "Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Light intervention delivered through SYNC app + blue-light blocking glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Blue-blocking glasses: Patient is given blue-blocking glasses to wear at instructed times. Full SYNC app: Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock. |
| OG001 | Control Arm | Placebo light intervention delivered through SYNC app + clear glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Clear glasses: Patient is given glasses that block no visible light. "Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T Score | baseline to 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T Score | baseline to 12 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | T Score | baseline to 12 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | T Score | baseline to 12 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | T Score | baseline to 12 weeks |
|
|
|
| 2 |
| 65 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Arm | Placebo light intervention delivered through SYNC app + clear glasses. Wearable Sensor: Patient is given a wearable device to wear for 12 weeks. Clear glasses: Patient is given glasses that block no visible light. "Dummy" SYNC app: Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock. | 4 | 66 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Pre-trial Mental Health |
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| Post-trial Mental Health |
|