Pilot Comparison of N-of-1 Trials of Light Therapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Depression, Healthy Studies |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/25/2018 |
| Start Date: | September 6, 2017 |
| End Date: | December 31, 2018 |
Comparison of N-of-1 Trials of Light Therapy for Depressive Symptoms in Cancer Survivors
This study compares the effect of two N-of-1 trials on study compliance with an N-of-1
protocol and on satisfaction with participation in an N-of-1 trial. Using within-person
analyses, the study also compares the effect of different types of light therapy on mood,
fatigue, sleep, physical activity, and side effects within a mild to moderately depressed
cancer survivor population. Ten participants will be randomized to the bright white versus
dim red light therapy N-of-1 trial, while the remaining 5 participants will be randomized to
a dim white versus dim red light comparator N-of-1 trial.
protocol and on satisfaction with participation in an N-of-1 trial. Using within-person
analyses, the study also compares the effect of different types of light therapy on mood,
fatigue, sleep, physical activity, and side effects within a mild to moderately depressed
cancer survivor population. Ten participants will be randomized to the bright white versus
dim red light therapy N-of-1 trial, while the remaining 5 participants will be randomized to
a dim white versus dim red light comparator N-of-1 trial.
Fatigue or low energy levels, trouble sleeping and feeling down are symptoms that represent
some of the most important concerns in cancer survivors, across a range of cancer types.
Despite the impact of these symptoms on quality of life, previous studies have shown that few
cancer survivors are receiving adequate treatment for these symptoms.
Light therapy involves the use of a light box (a box that lights up) in close proximity for a
specified amount of time each day. There can be big differences in the way light therapy
affects individual patients. Patients can learn whether this therapy is helpful to them by
engaging in an N-of-1 trial. An N-of-1 trial is an experiment conducted with one individual
(N refers to "number of individuals in the trial"). In an N-of-1 trial of light therapy, a
patient can try light therapy to learn whether it is beneficial to them. All participants
will receive two light boxes. The boxes will be labeled "A" and "B." Each light box will emit
a different intensity of light. An app will send reminder notifications to participants'
smartphones each morning to remind them which light box they should be using, depending on
the week. They will be asked to use Box A or Box B each morning for 30 minutes per day for 12
weeks
The purpose of this study is to empower cancer survivors with symptoms of fatigue, trouble
sleeping or who are feeling down to learn whether light therapy is helpful for them.
some of the most important concerns in cancer survivors, across a range of cancer types.
Despite the impact of these symptoms on quality of life, previous studies have shown that few
cancer survivors are receiving adequate treatment for these symptoms.
Light therapy involves the use of a light box (a box that lights up) in close proximity for a
specified amount of time each day. There can be big differences in the way light therapy
affects individual patients. Patients can learn whether this therapy is helpful to them by
engaging in an N-of-1 trial. An N-of-1 trial is an experiment conducted with one individual
(N refers to "number of individuals in the trial"). In an N-of-1 trial of light therapy, a
patient can try light therapy to learn whether it is beneficial to them. All participants
will receive two light boxes. The boxes will be labeled "A" and "B." Each light box will emit
a different intensity of light. An app will send reminder notifications to participants'
smartphones each morning to remind them which light box they should be using, depending on
the week. They will be asked to use Box A or Box B each morning for 30 minutes per day for 12
weeks
The purpose of this study is to empower cancer survivors with symptoms of fatigue, trouble
sleeping or who are feeling down to learn whether light therapy is helpful for them.
Inclusion Criteria:
- History of cancer (not including basal cell or squamous cell carcinoma, or carcinoma
in situ)
- Current mild to moderate severity depressive symptoms (PHQ-8 score 5 to 19)
- iPhone user
Exclusion Criteria:
- Has not completed primary cancer treatment including initial chemotherapy, surgical
resection, or radiation therapy
- Non-English speaking
- Severe depression (PHQ-8 score >=20) or active suicidal ideations
- Other severe mental illness that would preclude participation in a study that requires
extensive self-monitoring, including depression with psychotic features, other
psychotic disorder, bipolar disorder, severe personality disorder
- <6 months life expectancy due to cancer or other severe medical illness
- Other severe medical illness that would preclude ability to do daily self-tracking
- Unavailable for follow-up over the course of the 3 month trial
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-342-4147
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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