Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors

University of Toledo Health Science Campus1 site in 1 countryJanuary 27, 2020

ConditionsBreast Cancer Fatigue

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: University of Toledo Health Science Campus
Locations: 1
Primary Endpoint: Change in Fatigue Scores (Revised Piper Fatigue Scale)
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, Energy Conservation and Activity Management intervention among women who report cancer-related fatigue following breast cancer treatment.

Registry

clinicaltrials.gov

Start Date

January 27, 2020

End Date

September 1, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Toledo Health Science Campus

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•breast cancer diagnoses
•not currently receiving active treatment in the form of chemotherapy or radiation therapy
•at least 18 years of age
•fatigue severe enough to limit daily activities (score ≥ 4 on 7-point Fatigue Severity Scale)(Krupp, LaRocca, Muir-Nash, \& Steinberg, 1989);
•functional English fluency and literacy;
•Participant has a smart device that operates on the Android or Apple platform
•Participant is able to use the Ecological Momentary Assessment application before going to bed every night

Exclusion Criteria

•self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment,
•Disability due to a diagnosis other then breast cancer
•Currently taking medication for depression, sleep issues, or fatigue.

Outcomes

Primary Outcomes

Change in Fatigue Scores (Revised Piper Fatigue Scale)

Time Frame: Baseline to 14 weeks

Measure of fatigue severity and impact

Secondary Outcomes

Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)(Baseline to 14 weeks)
Change in Fatigue Impact (Modified Fatigue Impact Scale)(Baseline at 14 weeks)
Change in Severity of Fatigue Measured Via Ecological Momentary Assessments(Baseline to 14 weeks)