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

U

University of Toledo Health Science Campus

Status

Withdrawn

Conditions

Breast Cancer
Fatigue

Treatments

Behavioral: Energy Conservation Work Simplification Education

Study type

Interventional

Funder types

Other

Identifiers

NCT04160182
UT BCS ECS Study

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Energy Conservation Work Simplification Education
Experimental group
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.
Treatment:
Behavioral: Energy Conservation Work Simplification Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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