Clinical trial · Interventional
Cognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL
Cognitive Dysfunction and the Breast Cancer Patient: A Study to Determine the Impact of Providing Information on Coping Strategies on Quality of Life
NCT03476226CI-TRIAL-00081344completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether patients experience a better quality of life when they have received education about coping strategies for cognitive dysfunction.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Dysfunction Coping Strategy Teaching Sheet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- The research team will provide the intervention to subjects. Intervention: The nursing-driven Cognitive Dysfunction Coping Strategy Teaching Sheet and provide education as to its use. QOL survey administered
- interventionNames
- Other: Cognitive Dysfunction Coping Strategy Teaching Sheet
- type
- NO_INTERVENTION
- label
- Group 2
- description
- Provide current standard of education for cognitive dysfunction. QOL survey administered
Primary outcomes (1)
- measure
- FACT-Cog 3 questionnaire
- timeFrame
- 16 weeks
- description
- Assess QOL with use of FACT-Cog 3 questionnaire. Then compare group 1 that was provided teaching on coping strategies to Group 2 that received current standard of care. Determine impact on quality of life between subject groups based on statistical difference in Quality of Life between Group 1 and Group 2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18years old * Stage 0-IV breast cancer (excluding stage IV with metastasis to the brain) * Life expectancy \> 3 months * Able to speak and read English fluently * Self-reported cognitive difficulties that interfere with everyday activities * Reported Memory/Cognitive changes on Distress Thermometer * Able to provide written and informed consent * Willing to complete FACT-Cog questionnaire Exclusion Criteria: * Current Cognitive Training, for example, use of brain training, physical therapy, occupational or speech therapy for the sole purpose of improving cognitive function * Recent diagnosis of Major depression or other current psychiatric disorders and are not considered stable per a current care provider * History of Dementia or Alzheimer's Disease * History of Central Nervous System (CNS) radiation, intrathecal chemotherapy, or CNS involved surgery * History of metastatic disease extending to the brain * History of traumatic brain injury * History of seizure disorder * History of thyroid disorder (Subjects that are well managed without changes in thyroid medications or doses for at least 6 months may participate in study) * Current use of illicit substances and or alcohol (including medical marijuana) * Current sleep disturbance/disorder (Subjects that are well managed without changes in sleep medications or doses for at least 6 months may participate in study). * Concurrent use of antidepressants for example, use of antidepressants for pain management or smoking cessation. (Subjects that are well managed without changes on antidepressant medications or doses for at least 6 months may participate in study).
References
Publications (0)
Data not yet available
No reference posted for this study.