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Lighting Intervention for Cancer-related Fatigue

Primary Purpose

Breast Cancer, Prostate Cancer, Hematologic Malignancy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wearable Sensor

Blue-blocking glasses

Clear glasses

Full SYNC app

"Dummy" SYNC app

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Fatigue, light therapy, mobile app

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Must own an iPhone 6s or later (with iOS 14 or later or willing to update to iOS 14+) and be willing to complete surveys on it, per the protocol.
Sleep aid usage will be allowed as long as the patient has been on a stable dose for at least 4 weeks prior to enrollment and agrees to continue the same dose during the study.
A response of at least 4 on a 10 point scale (with 0 = not fatigued at all and 10 = extremely fatigued) to the question "How fatigued did you feel in the past week?"
Breast cancer population: Diagnosed with stage 1-3 breast cancer in the last 10 years, without metastatic disease. Chemotherapy or radiation therapy, if indicated, must have been completed at least 3 months prior to enrollment. Concomitant anti-HER2 therapy and/or anti-endocrine therapy is permitted.
Prostate cancer population: Undergoing androgen deprivation therapy (ADT) for at least three months and are anticipated to remain on ADT for the duration of the trial. Concomitant additional anti-androgen therapy (e.g., enzalutamide) is permitted.
Autologous HSCT population: Participants must be from the University of Michigan Blood and Marrow Transplant Program.

Exclusion Criteria

The patient cannot be undergoing chemotherapy at the time of enrollment, but post transplant maintenance therapy that begins after enrollment is allowed.
The patient must have no evidence of disease progression or recurrence. Specifically for the prostate cancer population, the patient must have no evidence of disease progression on their current ADT regimen at the time of enrollment.
The patient must not be a night shift worker, where night shift is defined as working a significant number of hours (i.e. more than half) between the hours of 11PM and 6AM on a regular basis.

Sites / Locations

University of Michigan Rogel Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Arm

Control Arm

Arm Description

Light intervention delivered through SYNC app + blue-light blocking glasses.

Placebo light intervention delivered through SYNC app + clear glasses.

Outcomes

Primary Outcome Measures

Change in fatigue assessed with Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a

The change from baseline in PROMIS 4-item Fatigue scores will enable the investigators to quantify the effects of the light interventions delivered by SYNC on patient fatigue. The final fatigue score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10 points. The average change in PROMIS fatigue T scores will be calculated for each arm. A negative change (lower scores) represents improvement in symptoms; a positive change (higher scores) represents worsening of symptoms. The study will have power of 0.80, assuming a two-sided Type I error rate of 0.05, to detect an effect size of half the standard deviation between the intervention and control arms if the accrual goal is reached.

Secondary Outcome Measures

Change in level of sleep disturbance using PROMIS SF Sleep Disturbance 8a

8-item PROMIS sleep disturbance questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Change in level of anxiety using PROMIS SF Anxiety 7a

7-item PROMIS anxiety questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Change in level of depression using PROMIS SF Depression 8a

8-item PROMIS depression questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Change in level of physical function using PROMIS SF Physical Function 8b

8-item PROMIS physical function questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Change in overall health metrics using PROMIS Global-10

PROMIS Global-10 is a 10-question survey used as an overall evaluation of one's physical and mental health. Raw scores are converted to T-scores. Higher scores reflect better functioning.

Full Information

NCT ID

NCT04827446

First Posted

March 29, 2021

Last Updated

October 23, 2023

Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Arcascope, Inc, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04827446

Brief Title

Lighting Intervention for Cancer-related Fatigue

Official Title

A Randomized Trial Of The SYNC APP

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

July 15, 2021 (Actual)

Primary Completion Date

March 9, 2023 (Actual)

Study Completion Date

March 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Michigan Rogel Cancer Center

Collaborators

Arcascope, Inc, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Fatigue is a major problem for cancer patients, and one that can persist long after treatment ends. Recent work has demonstrated that light therapy may mitigate or reduce fatigue levels in both cancer patients and cancer survivors. This protocol seeks to assess how lighting interventions distributed through a mobile app affect fatigue, sleep, and quality of life across three populations of cancer patients: breast cancer and prostate cancer, and patients who have undergone autologous hematopoietic stem cell transplant (HSCT). Participants will be randomized 1:1 to either the interventional SYNC app or to a control app.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Prostate Cancer, Hematologic Malignancy, Survivorship, Fatigue

Keywords

Fatigue, light therapy, mobile app

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Blocked randomization will be used to limit bias and achieve an equal distribution of participants to the intervention and control arms of the study (69 control, 69 intervention; with 23 from each cancer population in each arm). This approach will recruit participants in small blocks to ensure that half of the participants within each block will be allocated to the treatment and the other half to the control.

Masking

Participant

Allocation

Randomized

Enrollment

139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Light intervention delivered through SYNC app + blue-light blocking glasses.

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

Placebo light intervention delivered through SYNC app + clear glasses.

Intervention Type

Other

Intervention Name(s)

Wearable Sensor

Other Intervention Name(s)

Apple Watch or Fitbit Charge 3

Intervention Description

Patient is given a wearable device to wear for 12 weeks.

Intervention Type

Other

Intervention Name(s)

Blue-blocking glasses

Intervention Description

Patient is given blue-blocking glasses to wear at instructed times.

Intervention Type

Other

Intervention Name(s)

Clear glasses

Intervention Description

Patient is given glasses that block no visible light.

Intervention Type

Other

Intervention Name(s)

Full SYNC app

Intervention Description

Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.

Intervention Type

Other

Intervention Name(s)

"Dummy" SYNC app

Intervention Description

Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.

Primary Outcome Measure Information:

Title

Change in fatigue assessed with Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Fatigue 4a

Description

Time Frame

baseline, weekly to 12 weeks

Secondary Outcome Measure Information:

Title

Change in level of sleep disturbance using PROMIS SF Sleep Disturbance 8a

Description

8-item PROMIS sleep disturbance questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Time Frame

baseline to 12 weeks

Title

Change in level of anxiety using PROMIS SF Anxiety 7a

Description

7-item PROMIS anxiety questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Time Frame

baseline to 12 weeks

Title

Change in level of depression using PROMIS SF Depression 8a

Description

8-item PROMIS depression questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Time Frame

baseline to 12 weeks

Title

Change in level of physical function using PROMIS SF Physical Function 8b

Description

8-item PROMIS physical function questionnaire completed on the first day and last day of the patient's time on study. Each item is on a scale of 1 - 5, best (1) to worst (5).

Time Frame

baseline to 12 weeks

Title

Change in overall health metrics using PROMIS Global-10

Description

PROMIS Global-10 is a 10-question survey used as an overall evaluation of one's physical and mental health. Raw scores are converted to T-scores. Higher scores reflect better functioning.

Time Frame

baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Must own an iPhone 6s or later (with iOS 14 or later or willing to update to iOS 14+) and be willing to complete surveys on it, per the protocol. Sleep aid usage will be allowed as long as the patient has been on a stable dose for at least 4 weeks prior to enrollment and agrees to continue the same dose during the study. A response of at least 4 on a 10 point scale (with 0 = not fatigued at all and 10 = extremely fatigued) to the question "How fatigued did you feel in the past week?" Breast cancer population: Diagnosed with stage 1-3 breast cancer in the last 10 years, without metastatic disease. Chemotherapy or radiation therapy, if indicated, must have been completed at least 3 months prior to enrollment. Concomitant anti-HER2 therapy and/or anti-endocrine therapy is permitted. Prostate cancer population: Undergoing androgen deprivation therapy (ADT) for at least three months and are anticipated to remain on ADT for the duration of the trial. Concomitant additional anti-androgen therapy (e.g., enzalutamide) is permitted. Autologous HSCT population: Participants must be from the University of Michigan Blood and Marrow Transplant Program. Exclusion Criteria The patient cannot be undergoing chemotherapy at the time of enrollment, but post transplant maintenance therapy that begins after enrollment is allowed. The patient must have no evidence of disease progression or recurrence. Specifically for the prostate cancer population, the patient must have no evidence of disease progression on their current ADT regimen at the time of enrollment. The patient must not be a night shift worker, where night shift is defined as working a significant number of hours (i.e. more than half) between the hours of 11PM and 6AM on a regular basis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung Choi, MD

Organizational Affiliation

University of Michigan Rogel Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Rogel Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.arcascope.com/

Description

Related Info

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Lighting Intervention for Cancer-related Fatigue

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