Trial Outcomes & Findings for Effect of Increased Light Exposure on Fatigue in Breast Cancer (NCT NCT00478257)
NCT ID: NCT00478257
Last Updated: 2019-02-06
Results Overview
The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.
COMPLETED
NA
39 participants
four cycles of chemotherapy
2019-02-06
Participant Flow
Participant milestones
| Measure |
Effect of Bright Light
Effect of bright light on fatigue in women with breast cancer
|
Effect of Red Light
effect of red light on fatigue in women with breast cancer
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
16
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Effect of Bright Light
Effect of bright light on fatigue in women with breast cancer
|
Effect of Red Light
effect of red light on fatigue in women with breast cancer
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
Baseline Characteristics
Effect of Increased Light Exposure on Fatigue in Breast Cancer
Baseline characteristics by cohort
| Measure |
Effect of Bright Light
n=23 Participants
Effect of bright light on fatigue in women with breast cancer
|
Effect of Red Light
n=16 Participants
effect of red light on fatigue in women with breast cancer
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 9 • n=99 Participants
|
53.5 years
STANDARD_DEVIATION 9 • n=107 Participants
|
53.9 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
16 participants
n=107 Participants
|
39 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: four cycles of chemotherapyPopulation: All participants that were randomized and began the protocol were included in analyses.
The Short Form of the Multidimensional Fatigue Symptom Inventory (MFSI-sf) was used to measure fatigue. The range of possible score for each subscale is 0 to 24, and the range for total score is -24 to 96, with a higher score indicating more severe fatigue, except for the Vigor subscale, where larger score indicates less fatigue.
Outcome measures
| Measure |
Effect of Bright Light
n=23 Participants
Effect of bright light on fatigue in women with breast cancer
|
Effect of Red Light
n=16 Participants
effect of red light on fatigue in women with breast cancer
|
|---|---|---|
|
Fatigue
|
15.25 units on a scale
Standard Error 5.5
|
21.6 units on a scale
Standard Error 7.2
|
Adverse Events
Effect of Bright Light
Effect of Red Light
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place