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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Recruitment Status : Withdrawn (Due to COVID this trial never got up and running.)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
Sponsor:
Collaborator:
University of Toledo Medical Center
Information provided by (Responsible Party):
Danielle Mockensturm, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Fatigue Behavioral: Energy Conservation Work Simplification Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Change in Fatigue Scores (Revised Piper Fatigue Scale) [ Time Frame: Baseline to 14 weeks ]
    Measure of fatigue severity and impact


Secondary Outcome Measures :
  1. Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale) [ Time Frame: Baseline to 14 weeks ]
    Measure of fatigue severity and impact

  2. Change in Fatigue Impact (Modified Fatigue Impact Scale) [ Time Frame: Baseline at 14 weeks ]
    Measure of fatigue impact

  3. Change in Severity of Fatigue Measured Via Ecological Momentary Assessments [ Time Frame: Baseline to 14 weeks ]
    Ecological Momentary Assessments via Smartphone App



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Ohio
University of Toledo
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
Danielle Mockensturm
University of Toledo Medical Center
Investigators
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Principal Investigator: Ketki Raina, PhD, OTR/L The University of Toledo
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Responsible Party: Danielle Mockensturm, Associate Professor, University of Toledo Health Science Campus
ClinicalTrials.gov Identifier: NCT04160182    
Other Study ID Numbers: UT BCS ECS Study
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Danielle Mockensturm, University of Toledo Health Science Campus:
Breast cancer
fatigue
Intervention
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases