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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Fatigue

Intervention / Treatment
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* Behavioral: Energy Conservation Work Simplification Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Energy Conservation Work Simplification Education<br>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. | Behavioral: Energy Conservation Work Simplification Education<br>* The intervention will last approximately 45 minutes, and will be provided once/week for 6 weeks. The intervention is delivered live using web-cameras (e.g., Microsoft Zoom). Registered and licensed occupational therapists will deliver the intervention. At beginning of the intervention, the participant and interventionist prioritize the 5 most critical fatigue-related problems that they would like to solve during the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge and examples on how to apply the knowledge to everyday fatigue-related problems. The workbook contains: (a) information regarding fatigue in breast cancer survivors, (b) knowledge regarding fatigue management strategies, and (c) worksheets to develop skills to recognize and solve fatigue-related problems. Participants will retain the workbook after study completion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Scores (Revised Piper Fatigue Scale) | Measure of fatigue severity and impact | Baseline to 14 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, fatigue, Intervention