Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT04160182|
Recruitment Status : Withdrawn (Due to COVID this trial never got up and running.)
First Posted : November 12, 2019
Last Update Posted : November 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Fatigue||Behavioral: Energy Conservation Work Simplification Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors|
|Actual Study Start Date :||January 27, 2020|
|Actual Primary Completion Date :||September 1, 2020|
|Actual Study Completion Date :||September 1, 2020|
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.
- Change in Fatigue Scores (Revised Piper Fatigue Scale) [ Time Frame: Baseline to 14 weeks ]Measure of fatigue severity and impact
- Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale) [ Time Frame: Baseline to 14 weeks ]Measure of fatigue severity and impact
- Change in Fatigue Impact (Modified Fatigue Impact Scale) [ Time Frame: Baseline at 14 weeks ]Measure of fatigue impact
- Change in Severity of Fatigue Measured Via Ecological Momentary Assessments [ Time Frame: Baseline to 14 weeks ]Ecological Momentary Assessments via Smartphone App
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160182
|United States, Ohio|
|University of Toledo|
|Toledo, Ohio, United States, 43606|
|Principal Investigator:||Ketki Raina, PhD, OTR/L||The University of Toledo|