Trial Outcomes & Findings for Feasibility of Bright Light Therapy on Fatigue, Sleep and Circadian Activity Rhythms in Lung Cancer Survivors (NCT NCT02954809)

NCT ID: NCT02954809

Last Updated: 2025-05-01

Results Overview

The percentage of participants recruited that completed the study

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

Baseline

Results posted on

2025-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	7	7
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline

The percentage of participants recruited that completed the study

Outcome measures

Outcome measures
Measure	Experimental n=7 Participants 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.	Attention Control n=7 Participants 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.
Study Completion	7 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 weeks

Quality of Life will be assessed before, during, and after the intervention.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 weeks

Exposure to environmental light will be assessed at pre-test, intervention and post-test for a descriptive analysis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

Chronotype will be assessed at baseline for a descriptive analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 weeks

Comparison of fatigue severity from pre-test to post-test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 Weeks

Comparison of Sleep Quality from pre-test to post-test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 weeks

Comparison of insomnia from pre-test to post-test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 weeks

Circadian Activity Rhythms will be assessed with actigraphy during the 5-week time frame.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 5 weeks

Visual acuity data will be collected and save for safety purposes only at pre-test and post-test.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carleara Weiss

University at Buffalo

Phone: 716-829-2006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Experimental n=7 Participants 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.	Attention Control n=5 Participants 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.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • 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.	0 Participants n=7 Participants • 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.	0 Participants n=5 Participants • 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.
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants • 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.	2 Participants n=7 Participants • 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.	4 Participants n=5 Participants • 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.
Age, Categorical >=65 years	5 Participants n=5 Participants • 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.	3 Participants n=7 Participants • 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.	8 Participants n=5 Participants • 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.
Sex: Female, Male Female	5 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	4 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	9 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Sex: Female, Male Male	2 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	1 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	3 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	5 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	12 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Race (NIH/OMB) Asian	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Race (NIH/OMB) White	7 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	5 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	12 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=7 Participants • Total participants recruited n=14 Participants that completed study n=12	0 Participants n=5 Participants • Total participants recruited n=14 Participants that completed study n=12
Region of Enrollment United States	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants