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

Not Applicable

Withdrawn

• Conditions: Fatigue; Breast Cancer
• Interventions: Behavioral: Energy Conservation Work Simplification Education

• Registration Number: NCT04160182
• Lead Sponsor: University of Toledo Health Science Campus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Study Start: 2020-01-27
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Energy Conservation Work Simplification Education	Energy Conservation Work Simplification Education	The intervention will be delivered online by an occupational therapist. The intervention consists of 6 weekly sessions; each session will be 45 minutes long. The focus of the intervention is to teach breast cancer survivors strategies to manage their fatigue.

Primary Outcome Measures

Name	Time	Method
Change in Fatigue Scores (Revised Piper Fatigue Scale)	Baseline to 14 weeks	Measure of fatigue severity and impact

Secondary Outcome Measures

Name	Time	Method
Change in Severity of Fatigue Measured Via Ecological Momentary Assessments	Baseline to 14 weeks	Ecological Momentary Assessments via Smartphone App
Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)	Baseline to 14 weeks	Measure of fatigue severity and impact
Change in Fatigue Impact (Modified Fatigue Impact Scale)	Baseline at 14 weeks	Measure of fatigue impact

Trial Locations

Locations (1)

University of Toledo; 🇺🇸 Toledo, Ohio, United States