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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04160182
Enrollment
0
Registered
2019-11-12
Start date
2020-01-27
Completion date
2020-09-01
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Fatigue

Keywords

Breast cancer, fatigue, Intervention

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.

Interventions

BEHAVIORALEnergy 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.

Sponsors

University of Toledo
CollaboratorOTHER
University of Toledo Health Science Campus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Fatigue Scores (Revised Piper Fatigue Scale)Baseline to 14 weeksMeasure of fatigue severity and impact

Secondary

MeasureTime frameDescription
Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)Baseline to 14 weeksMeasure of fatigue severity and impact
Change in Fatigue Impact (Modified Fatigue Impact Scale)Baseline at 14 weeksMeasure of fatigue impact
Change in Severity of Fatigue Measured Via Ecological Momentary AssessmentsBaseline to 14 weeksEcological Momentary Assessments via Smartphone App

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026