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Completed

NCT Number: NCT03167372

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Litebook® Advantage

Other

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.

Other names: Litebook Advantage Portable Light Therapy

Fitbit Flex2 TM

Other

Standard system activity and sleep tracker

Other names: Fitbit actigraph

Primary outcomes

  1. Protocol Compliance

    Time frame: 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

  2. Participant Satisfaction

    Time frame: 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 outcomes

  1. Depressive symptoms

    Time frame: 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.

  2. Fatigue

    Time frame: 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.

  3. Side effects

    Time frame: 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.

  4. Physical activity

    Time frame: 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.

  5. Treatment preference for bright white light therapy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 30, 2017
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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