NCT01780623

Brief Summary

Cancer-related fatigue is one of the most common and distressing symptoms associated with a cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during treatment, and lasts for years after treatment in up to 35% of patients. Despite the long-term effects of cancer-related fatigue, the treatment options available are not always appropriate or helpful for all patients.Light therapy is an effective treatment for other disorders related to fatigue. The purpose of the study is to investigate the role of light therapy on quality of life, sleep patterns, and physical measures of immune function and stress hormones in individuals with post-treatment cancer-related fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable cancer

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

Study Start

First participant enrolled

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

January 22, 2013

Last Update Submit

April 6, 2016

Conditions

Cancer

Keywords

fatiguesleepquality of lifelightcancer

Outcome Measures

Primary Outcomes (1)

  • Change in fatigue symptoms from baseline to post-treatment

    Baseline, after each treatment week (each week for 4 weeks), and at week 5

Secondary Outcomes (8)

  • Change in objective measures of sleep using wrist actigraphy from baseline to post-treatment

    Baseline (for 7 days), week 5 (for 7 days)

  • Change in subjective measures of sleep using sleep diaries from baseline to post-treatment

    Baseline (for 7 days), week 5 (for 7 days)

  • Change in Pittsburgh Sleep Quality Index scores from baseline to post-treatment

    Baseline, week 5

  • Change in Profile of Mood States scores from baseline to post-treatment

    Baseline, week 5

  • Change in Functional Assessment of Cancer Therapy (General & Fatigue) scores from baseline to post-treatment

    Baseline, week 5

  • +3 more secondary outcomes

Study Arms (2)

Bright White Light

EXPERIMENTAL

Bright white light exposure every morning for 30 minutes for 28 consecutive days

Device: Bright white light

Dim Red Light

ACTIVE COMPARATOR

Dim red light exposure every morning for 30 minutes for 28 consecutive days

Device: Dim red light

Interventions

Bright white lightDEVICE
Also known as: Light box, LiteBook
Bright White Light
Dim red lightDEVICE
Also known as: Light box, LiteBook
Dim Red Light

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Non metastatic cancer
  • At least 3 months post chemotherapy/radiation treatment (hormone treatment ok)
  • Meets criteria for cancer-related fatigue

You may not qualify if:

  • Under 18 years of age
  • Presence of a sleep disorder other than insomnia or hypersomnia
  • Shift work
  • Presence of an Axis-I psychiatric condition
  • Presence of a medical condition that may impact levels of fatigue
  • Presence of conditions contraindicated to the use of light therapy or photosensitizing medications
  • Randomization refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioural Medicine Laboratory

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

  • Johnson JA, Subnis U, Carlson LE, Garland SN, Santos-Iglesias P, Piedalue KL, Deleemans JM, Campbell TS. Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial. J Psychosom Res. 2020 Dec;139:110266. doi: 10.1016/j.jpsychores.2020.110266. Epub 2020 Oct 6.

    PMID: 33070045DERIVED

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Officials

  • Tavis S Campbell, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Tavis S. Campbell

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 31, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

CA(1)