CancerNCT03167372
Pilot Comparison of N-of-1 Trials of Light Therapy
A study testing Litebook® Advantage and Fitbit Flex2 TM in people with Cancer and Health Behavior, run by Columbia University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer, Health Behavior, Depression
- What is being tested?
- Litebook® Advantage and Fitbit Flex2 TM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Health Behavior, Depression
- Being tested
- Litebook® Advantage, Fitbit Flex2 TM
- Keywords
- Light Therapy, N-of-1
- Medical subject headings
- Neoplasms, Health Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Litebook® AdvantageOther
Also called Litebook Advantage Portable Light Therapy
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 TMOther
Also called Fitbit actigraph
Standard system activity and sleep tracker
| Study group | Role | What they receive |
|---|---|---|
| Bright white light vs dim red light | Experimental | A balanced sequence (ABBA) over a 12 week period of bright white light and dim red light; alternating bright white and dim red light every 3 weeks.
Subjects will receive 2 Litebook® Advantage lightboxes - 1 bright white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks. Receives: Other: Litebook® Advantage; Other: Fitbit Flex2 TM |
| Dim white light vs dim red light | Active comparator | A balanced sequence (ABBA) over a 12 week period of dim white light and dim red light; alternating dim white and dim red light every 3 weeks.
Subjects will receive 2 Litebook® Advantage lightboxes - 1 dim white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks. Receives: Other: Litebook® Advantage; Other: Fitbit Flex2 TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Compliance
The proportion of participants randomized to the N-of-1 trial group who are compliant with the N-of-1 trial protocol
Measured: Length of study (3 months)
Participant Satisfaction
The proportion of participants randomized to the N-of-1 trial who are satisfied with the N-of-1 trial protocol
Measured: Length of study (3 months)
Secondary outcomes (5)
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.
Measured: Length of study (3 months)
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.
Measured: Length of study (3 months)
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.
Measured: Length of study (3 months)
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.
Measured: Length of study (3 months)
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.
Measured: Length of study (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start6 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ian Kronish, Columbia University
- Investigators
- Ian Kronish, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167372
- Sponsor's protocol ID
- AAAR1273
- Other IDs
- HHSN261200800001E
- Status last verified
- Jun 2019
- First submitted
- 24 May 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of N-of-1 Trials of Light Therapy for Depressive Symptoms in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03167372
- Acronym / sponsor ID
- AAAR1273
- Conditions
- Cancer, Health Behavior, Depression
- Keywords
- Light Therapy, N-of-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Bright white light vs dim red light | Experimental | Other: Litebook® Advantage, Other: Fitbit Flex2 TMA balanced sequence (ABBA) over a 12 week period of bright white light and dim red light; alternating bright white and dim red light every 3 weeks. Subjects will receive 2 Litebook® Advantage lightboxes - 1 bright white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks. |
| Dim white light vs dim red light | Active comparator | Other: Litebook® Advantage, Other: Fitbit Flex2 TMA balanced sequence (ABBA) over a 12 week period of dim white light and dim red light; alternating dim white and dim red light every 3 weeks. Subjects will receive 2 Litebook® Advantage lightboxes - 1 dim white and 1 dim red. Information such as mood, fatigue, sleep and light therapy side effects will be self-reported using a smartphone diary; physical activity and sleep will also be reported using a Fitbit Flex2 TM. Data visualization at 12 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Litebook® AdvantageAlso: Litebook Advantage Portable Light TherapyStandard 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 | Bright white light vs dim red light, Dim white light vs dim red light |
| Fitbit Flex2 TMAlso: Fitbit actigraphStandard system activity and sleep tracker | Other | Bright white light vs dim red light, Dim white light vs dim red light |
Primary outcome
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
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
5 secondary outcomes
Depressive symptoms
Time frame: Length of study (3 months)
Fatigue
Time frame: Length of study (3 months)
Side effects
Time frame: Length of study (3 months)
Physical activity
Time frame: Length of study (3 months)
Treatment preference for bright white light therapy
Time frame: Length of study (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Kronish, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Litebook® Advantage and Fitbit Flex2 TM in people with Cancer and Health Behavior, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Compliance (time frame: Length of study (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.