NCT02677987

Brief Summary

Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 18, 2022

Completed
Last Updated

April 18, 2022

Status Verified

March 1, 2022

Enrollment Period

3.5 years

First QC Date

January 22, 2016

Results QC Date

February 7, 2022

Last Update Submit

March 22, 2022

Conditions

Hematopoietic Stem Cell TransplantationCognitive ImpairmentsSleepDepressionFatigueQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Cognitive Functioning (Neuropsychological Tests)

    Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.

    Baseline to end-of-intervention to 8 weeks after the intervention

Secondary Outcomes (10)

  • Circadian Activity Rhythms (Actigraphy)

    Baseline to end of intervention to 8 weeks later

  • Sleep Quality (Pittsburgh Sleep Quality Index)

    Baseline, mid intervention, end of intervention, 8 weeks later

  • Fatigue (FACIT-fatigue)

    Baseline, mid-intervention, end of the intervention, 8 weeks later

  • Depressed Mood (CESD)

    Baseline, Mid-intervention, End of intervention, 8 weeks later

  • Neurobehavioral Functioning (Frontal Systems Behavioral Scale)

    Baseline, mid-intervention, end-of-intervention, 8 weeks later

  • +5 more secondary outcomes

Other Outcomes (4)

  • Treatment Satisfaction (FACT-TS)

    During the 4th week of the intervention

  • Credibility/Expectancy (Credibility/Expectancy Questionnaire)

    Baseline

  • Usage of Light Box (Integrated Meter Measurement and Litebook Log)

    Throughout intervention period (4 weeks)

  • +1 more other outcomes

Study Arms (2)

Intervention light

EXPERIMENTAL

30 minutes of intervention systematic light exposure daily for 4 weeks.

Device: Intervention systematic light exposure

Comparison light

ACTIVE COMPARATOR

30 minutes of comparison systematic light exposure daily for 4 weeks.

Device: Comparison systematic light exposure

Interventions

Intervention systematic light exposureDEVICE

Bright light using Litebook device.

Intervention light
Comparison systematic light exposureDEVICE

Dim light using modified Litebook device.

Comparison light

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a history of HSCT,
  • to 5 years post-HSCT,
  • Relapse-free since most recent HSCT,
  • Age 21 or older,
  • English language proficient
  • Able to provide informed consent
  • Endorse subjective cognitive impairment.

You may not qualify if:

  • Diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment),
  • Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation,
  • Have a history of whole brain irradiation or surgery,
  • Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes,
  • Chronic use of oral steroid medication,
  • History of systematic light exposure treatment,
  • Diagnosed sleep apnea or narcolepsy,
  • Use of photosensitizing medications,
  • Plan to travel across meridians during the study,
  • Work night, early morning, or swing shifts,
  • Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Wu LM, Valdimarsdottir HB, Amidi A, Reid KJ, Ancoli-Israel S, Bovbjerg K, Fox RS, Walker L, Matharu A, Kaseda ET, Galvin JP, Adekola K, Winkel G, Penedo F, Redd WH. Examining the Efficacy of Bright Light Therapy on Cognitive Function in Hematopoietic Stem Cell Transplant Survivors. J Biol Rhythms. 2022 Oct;37(5):471-483. doi: 10.1177/07487304221107833. Epub 2022 Jul 29.

    PMID: 35904252DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionDepressionFatigue

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lisa M. Wu, Ph.D.
Organization
Northwestern University Feinberg School of Medicine
lisa.wu1@northwestern.edu
(312) 503-7722

Study Officials

  • Lisa M Wu, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 9, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2019

Study Completion

March 1, 2021

Last Updated

April 18, 2022

Results First Posted

April 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)