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| Name | Class |
|---|---|
| Oncology Nursing Society | OTHER |
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The purpose of this study is to determine the feasibility of a morning bright light therapy intervention for fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.
A randomized controlled trial to test the effects of morning bright light therapy on fatigue, sleep disturbances, and circadian activity rhythms in lung cancer survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. |
|
| Attention Control | Active Comparator | Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morning bright light therapy | Device | Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Completion | The percentage of participants recruited that completed the study | Baseline |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Quality of Life With theFunctional Assessment of Cancer Therapy - Lung | Quality of Life will be assessed before, during, and after the intervention. | 5 weeks |
| Assessment of Environmental Light With Actigraphy (Actiwatch Spectrum Respironics) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY University at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23989018 | Background | Dean GE, Redeker NS, Wang YJ, Rogers AE, Dickerson SS, Steinbrenner LM, Gooneratne NS. Sleep, mood, and quality of life in patients receiving treatment for lung cancer. Oncol Nurs Forum. 2013 Sep;40(5):441-51. doi: 10.1188/13.ONF.441-451. | |
| 21660669 | Background | Ancoli-Israel S, Rissling M, Neikrug A, Trofimenko V, Natarajan L, Parker BA, Lawton S, Desan P, Liu L. Light treatment prevents fatigue in women undergoing chemotherapy for breast cancer. Support Care Cancer. 2012 Jun;20(6):1211-9. doi: 10.1007/s00520-011-1203-z. Epub 2011 Jun 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. Morning bright light therapy: Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. |
| FG001 | Attention Control | Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. Dim light: Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. Morning bright light therapy: Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Total participants that completed study n=12 We recruited 14 participants. Two participants from the attention control group were excluded based on the study exclusion criteria (1) rotating shift work (2) decline in overall health condition/cancer treatment. The intent is to report the number of participants who completed the study out of the total enrolled. |
| 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 | Study Completion | The percentage of participants recruited that completed the study | Posted | Count of Participants | Participants | Baseline |
|
5 weeks
Although no adverse events were reported in this study, anticipated adverse events included eye strain and headache.
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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 | Experimental | Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. Morning bright light therapy: Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carleara Weiss | University at Buffalo | 716-829-2006 | carleara@buffalo.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 | Jan 29, 2017 | Feb 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D020447 | Parasomnias |
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Dim light | Device | Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. |
|
Exposure to environmental light will be assessed at pre-test, intervention and post-test for a descriptive analysis
| 5 weeks |
| Assessement of Chronotype With the Morningness Versus Eveningness Questionnaire | Chronotype will be assessed at baseline for a descriptive analysis. | 1 day |
| Change in Fatigue Symptoms With Fatigue Severity Index From Pre-test to Post-test | Comparison of fatigue severity from pre-test to post-test. | 5 weeks |
| Change in Sleep Quality With the Pittsburgh Sleep Quality Index From Pre-test to Post-test | Comparison of Sleep Quality from pre-test to post-test. | 5 Weeks |
| Changes in Insomnia With Insomnia Severity Index From Pre-test to Post-test | Comparison of insomnia from pre-test to post-test. | 5 weeks |
| Change in Circadian Activity Rhythms With Actigraphy From Pre-test to Post-test | Circadian Activity Rhythms will be assessed with actigraphy during the 5-week time frame. | 5 weeks |
| Assessment of Visual Acuity With the Snellen Visual Acuity Chart | Visual acuity data will be collected and save for safety purposes only at pre-test and post-test. | 5 weeks |
| Assessment of Daytime Sleepiness With the Epworth Sleepiness Scale | Daytime Sleepiness will be assessed for safety purposes only at pre-test, intervention and post-test. Individuals with high daytime sleepiness and/or at risk of falling asleep while driving or performing hazardous activities will be referred out to primary care | 5 weeks |
| 22865153 | Background | Jeste N, Liu L, Rissling M, Trofimenko V, Natarajan L, Parker BA, Ancoli-Israel S. Prevention of quality-of-life deterioration with light therapy is associated with changes in fatigue in women with breast cancer undergoing chemotherapy. Qual Life Res. 2013 Aug;22(6):1239-44. doi: 10.1007/s11136-012-0243-2. Epub 2012 Aug 3. |
| 24733634 | Background | Ancoli-Israel S, Liu L, Rissling M, Natarajan L, Neikrug AB, Palmer BW, Mills PJ, Parker BA, Sadler GR, Maglione J. Sleep, fatigue, depression, and circadian activity rhythms in women with breast cancer before and after treatment: a 1-year longitudinal study. Support Care Cancer. 2014 Sep;22(9):2535-45. doi: 10.1007/s00520-014-2204-5. Epub 2014 Apr 15. |
| 24798589 | Background | Redd WH, Valdimarsdottir H, Wu LM, Winkel G, Byrne EE, Beltre MA, Liebman ES, Erazo T, Hayes JA, Isola L, Scigliano E, Meschian Y, Lutgendorf S, Ancoli-Israel S. Systematic light exposure in the treatment of cancer-related fatigue: a preliminary study. Psychooncology. 2014 Dec;23(12):1431-4. doi: 10.1002/pon.3553. Epub 2014 May 2. No abstract available. |
| Attention Control |
Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. Dim light: Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Total participants recruited n=14 Participants that completed study n=12 | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Total participants recruited n=14 Participants that completed study n=12 | Count of Participants | Participants |
|
| Race (NIH/OMB) | Total participants recruited n=14 Participants that completed study n=12 | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Changes in Quality of Life With theFunctional Assessment of Cancer Therapy - Lung | Quality of Life will be assessed before, during, and after the intervention. | Not Posted | 5 weeks | Participants |
| Other Pre-specified | Assessment of Environmental Light With Actigraphy (Actiwatch Spectrum Respironics) | Exposure to environmental light will be assessed at pre-test, intervention and post-test for a descriptive analysis | Not Posted | 5 weeks | Participants |
| Other Pre-specified | Assessement of Chronotype With the Morningness Versus Eveningness Questionnaire | Chronotype will be assessed at baseline for a descriptive analysis. | Not Posted | 1 day | Participants |
| Other Pre-specified | Change in Fatigue Symptoms With Fatigue Severity Index From Pre-test to Post-test | Comparison of fatigue severity from pre-test to post-test. | Not Posted | 5 weeks | Participants |
| Other Pre-specified | Change in Sleep Quality With the Pittsburgh Sleep Quality Index From Pre-test to Post-test | Comparison of Sleep Quality from pre-test to post-test. | Not Posted | 5 Weeks | Participants |
| Other Pre-specified | Changes in Insomnia With Insomnia Severity Index From Pre-test to Post-test | Comparison of insomnia from pre-test to post-test. | Not Posted | 5 weeks | Participants |
| Other Pre-specified | Change in Circadian Activity Rhythms With Actigraphy From Pre-test to Post-test | Circadian Activity Rhythms will be assessed with actigraphy during the 5-week time frame. | Not Posted | 5 weeks | Participants |
| Other Pre-specified | Assessment of Visual Acuity With the Snellen Visual Acuity Chart | Visual acuity data will be collected and save for safety purposes only at pre-test and post-test. | Not Posted | 5 weeks | Participants |
| Other Pre-specified | Assessment of Daytime Sleepiness With the Epworth Sleepiness Scale | Daytime Sleepiness will be assessed for safety purposes only at pre-test, intervention and post-test. Individuals with high daytime sleepiness and/or at risk of falling asleep while driving or performing hazardous activities will be referred out to primary care | Not Posted | 5 weeks | Participants |
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Attention Control | Exposure to dim light delivered with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. Dim light: Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D001523 | Mental Disorders |