Pilot Comparison of N-of-1 Trials of Light Therapy

Depression Clinical Trial

Official title:

Comparison of N-of-1 Trials of Light Therapy for Depressive Symptoms in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167372
• Other study ID #: AAAR1273
• Secondary ID: HHSN261200800001
• Status: Completed
• Phase: N/A
• Start date: September 6, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Depression
• Health Behavior

Intervention

Other:
• Litebook® 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.
• Fitbit Flex2 TM
Standard system activity and sleep tracker

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protocol Compliance	The proportion of participants randomized to the N-of-1 trial group who are compliant with the N-of-1 trial protocol	Length of study (3 months)
Primary	Participant Satisfaction	The proportion of participants randomized to the N-of-1 trial who are satisfied with the N-of-1 trial protocol	Length of study (3 months)
Secondary	Depressive symptoms	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.	Length of study (3 months)
Secondary	Fatigue	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.	Length of study (3 months)
Secondary	Side effects	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.	Length of study (3 months)
Secondary	Physical activity	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.	Length of study (3 months)
Secondary	Treatment preference for bright white light therapy	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.	Length of study (3 months)