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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04160182
• Other study ID #: UT BCS ECS Study
• Status: Withdrawn
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

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.

Locations

Country	Name	City	State
United States	University of Toledo	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Danielle Mockensturm	University of Toledo Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fatigue Scores (Revised Piper Fatigue Scale)	Measure of fatigue severity and impact	Baseline to 14 weeks
Secondary	Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)	Measure of fatigue severity and impact	Baseline to 14 weeks
Secondary	Change in Fatigue Impact (Modified Fatigue Impact Scale)	Measure of fatigue impact	Baseline at 14 weeks
Secondary	Change in Severity of Fatigue Measured Via Ecological Momentary Assessments	Ecological Momentary Assessments via Smartphone App	Baseline to 14 weeks