Clinical trial · Interventional
Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors
NCT04160182CI-TRIAL-00083028withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to COVID this trial never got up and running.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Energy Conservation Work Simplification Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Energy Conservation Work Simplification Education
- 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.
- interventionNames
- Behavioral: Energy Conservation Work Simplification Education
Primary outcomes (1)
- measure
- Change in Fatigue Scores (Revised Piper Fatigue Scale)
- timeFrame
- Baseline to 14 weeks
- description
- Measure of fatigue severity and impact
Secondary outcomes (3)
- measure
- Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.