Fatigue, Sleep Disturbance, Circadian Dysregulation
Conditions
Keywords
fatigue, sleep disturbances, circadian activity rhythms
Brief summary
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.
Detailed description
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.
Interventions
Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week.
DEVICEDim light
Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.
Sponsors
Oncology Nursing Society
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stage I-III Non-small cell lung cancer survivors * Must be at \>6-weeks and \< 3 years post-surgical resection * Must have diagnosis fatigue and/or sleep disturbances
Exclusion criteria
* Individuals clinically unstable. * Mania, Bipolar disease or seizure disorder * Macular degeneration or glaucoma. * Currently receiving chemotherapy or radiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Completion | Baseline | The percentage of participants recruited that completed the study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Environmental Light With Actigraphy (Actiwatch Spectrum Respironics) | 5 weeks | Exposure to environmental light will be assessed at pre-test, intervention and post-test for a descriptive analysis |
| Assessement of Chronotype With the Morningness Versus Eveningness Questionnaire | 1 day | Chronotype will be assessed at baseline for a descriptive analysis. |
| Change in Fatigue Symptoms With Fatigue Severity Index From Pre-test to Post-test | 5 weeks | Comparison of fatigue severity from pre-test to post-test. |
| Change in Sleep Quality With the Pittsburgh Sleep Quality Index From Pre-test to Post-test | 5 Weeks | Comparison of Sleep Quality from pre-test to post-test. |
| Changes in Quality of Life With theFunctional Assessment of Cancer Therapy - Lung | 5 weeks | Quality of Life will be assessed before, during, and after the intervention. |
| Change in Circadian Activity Rhythms With Actigraphy From Pre-test to Post-test | 5 weeks | Circadian Activity Rhythms will be assessed with actigraphy during the 5-week time frame. |
| Assessment of Visual Acuity With the Snellen Visual Acuity Chart | 5 weeks | Visual acuity data will be collected and save for safety purposes only at pre-test and post-test. |
| Assessment of Daytime Sleepiness With the Epworth Sleepiness Scale | 5 weeks | 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 |
| Changes in Insomnia With Insomnia Severity Index From Pre-test to Post-test | 5 weeks | Comparison of insomnia from pre-test to post-test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 5 |
| Total | 12 |
Baseline characteristics
| Characteristic | Experimental | Attention Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 5 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 5 Participants | 12 Participants |
| Region of Enrollment United States | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
Primary
Study Completion
The percentage of participants recruited that completed the study
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Study Completion | 7 Participants |
| Attention Control | Study Completion | 5 Participants |
Other Pre-specified
Assessement of Chronotype With the Morningness Versus Eveningness Questionnaire
Chronotype will be assessed at baseline for a descriptive analysis.
Time frame: 1 day
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
Time frame: 5 weeks
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
Time frame: 5 weeks
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.
Time frame: 5 weeks
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.
Time frame: 5 weeks
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.
Time frame: 5 weeks
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.
Time frame: 5 Weeks
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.
Time frame: 5 weeks
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.
Time frame: 5 weeks