Cancer, Depression, Health Behavior
Conditions
Keywords
Light Therapy, N-of-1
Brief summary
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.
Detailed description
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.
Interventions
OTHERLitebook® Advantage
Standard system light therapy device used in an investigation to assess the feasibility of conducting a randomized trial design. The lightbox produces different wavelengths of the light identical to the peak wavelengths of the sun - bright white, dim white and red light.
OTHERFitbit Flex2 TM
Standard system activity and sleep tracker
Sponsors
National Cancer Institute (NCI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study aims to assess the feasibility of conducting a randomized trial comparing two N-of-1 trials of light therapy in cancer survivors with depressive symptoms. In the first N-of-1 trial, participants will compare bright white light with dim red light therapy. In the second N-of-1 trial, participants will compare dim white light with dim red light. Participants will be randomized in a 2:1 ratio to either the N-of-1 bright white light vs dim red light experimental arm (N=20) or to a dim white vs dim red light therapy active comparator (N=10).
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Compliance | Length of study (3 months) | The proportion of participants randomized to the N-of-1 trial group who are compliant with the N-of-1 trial protocol |
| Participant Satisfaction | Length of study (3 months) | The proportion of participants randomized to the N-of-1 trial who are satisfied with the N-of-1 trial protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | Length of study (3 months) | At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on days with perceived side-effects as measured by a smart phone daily diary. |
| Depressive symptoms | Length of study (3 months) | At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on mood as measured by a daily visual analog scale. |
| Treatment preference for bright white light therapy | Length of study (3 months) | Within the bright white light experimental arm, the proportion who preferred to continue bright white light after the conclusion of the N-of-1 trial. |
| Physical activity | Length of study (3 months) | At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on physical activity as measured by a Fitbit. |
| Fatigue | Length of study (3 months) | At the single-patient level in the bright white light experimental arm, effect of bright light versus dim white light on fatigue as measured by a daily visual analog scale. |
Countries
United States
Outcome results
None listed