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

Primary Purpose

Breast Cancer, Fatigue

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Conservation Work Simplification Education
Sponsored by
Danielle Mockensturm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, fatigue, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Toledo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Energy Conservation Work Simplification Education

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Fatigue Scores (Revised Piper Fatigue Scale)
Measure of fatigue severity and impact

Secondary Outcome Measures

Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)
Measure of fatigue severity and impact
Change in Fatigue Impact (Modified Fatigue Impact Scale)
Measure of fatigue impact
Change in Severity of Fatigue Measured Via Ecological Momentary Assessments
Ecological Momentary Assessments via Smartphone App

Full Information

First Posted
November 1, 2019
Last Updated
November 3, 2020
Sponsor
Danielle Mockensturm
Collaborators
University of Toledo
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1. Study Identification

Unique Protocol Identification Number
NCT04160182
Brief Title
Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors
Official Title
Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Due to COVID this trial never got up and running.
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Danielle Mockensturm
Collaborators
University of Toledo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue
Keywords
Breast cancer, fatigue, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energy Conservation Work Simplification Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Energy Conservation Work Simplification Education
Intervention Description
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 Measure Information:
Title
Change in Fatigue Scores (Revised Piper Fatigue Scale)
Description
Measure of fatigue severity and impact
Time Frame
Baseline to 14 weeks
Secondary Outcome Measure Information:
Title
Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)
Description
Measure of fatigue severity and impact
Time Frame
Baseline to 14 weeks
Title
Change in Fatigue Impact (Modified Fatigue Impact Scale)
Description
Measure of fatigue impact
Time Frame
Baseline at 14 weeks
Title
Change in Severity of Fatigue Measured Via Ecological Momentary Assessments
Description
Ecological Momentary Assessments via Smartphone App
Time Frame
Baseline to 14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketki Raina, PhD, OTR/L
Organizational Affiliation
University of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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