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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Fatigue
• Intervention / Treatment: Behavioral: Energy Conservation Work Simplification Education

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • University of Toledo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Energy Conservation Work Simplification Education; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus
• Collaborators: University of Toledo
• Investigators: Principal Investigator: Ketki Raina, PhD, OTR/L, University of Toledo

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: fatigue; Breast cancer; Intervention
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Fatigue
• Other Study ID Numbers: UT BCS ECS Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No