Clinical trial NCT03476226: Cognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL
Official title: Cognitive Dysfunction and the Breast Cancer Patient: A Study to Determine the Impact of Providing Information on Coping Strategies on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Quality of Life
Cognitive Dysfunction
Breast Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Cancer treatment may consist of chemotherapy, radiation, hormone therapy, surgery or a combination of all disciplines. However, breast cancer therapies have at times demonstrated distressing effects in patients/survivors during and/or following treatment. One area that is found to cause distress for the breast cancer patient is changes in cognitive function.

Areas most commonly impacted by changes in cognitive function as a result of chemotherapy include executive functioning (including judgment, hindsight and foresight), processing speed or reaction time, working memory, and organizational skills.

Due to the limited amount of research involving quality of life as related to cognitive dysfunction, there is a clear need for additional investigation. Treatment typically focuses on the physical and psychosocial aspects of patients/survivors, however emphasis should also be placed on the impact of quality of life during treatment and survivorship due to the potential for far-reaching effects as previously discussed.

Oncology nurses may be instrumental in identifying patients with Cognitive Dysfunction. In doing so, the nurse may then communicate with the patient/survivor as to the impact of Cognitive Dysfunction on quality of life. The nurse can provide appropriate education and or additional support options.

Eligibility criteria: 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).

Primary outcomes:
measure: FACT-Cog 3 questionnaire
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barrington
country: United States
facility: Advocate Good Shepherd Hospital
state: Illinois
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Elgin
country: United States
facility: Advocate Sherman Hospital
state: Illinois
city: Hazel Crest
country: United States
facility: Advocate South Suburban Hospital
state: Illinois
city: Libertyville
country: United States
facility: Advocate Condell Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: Katharine L Szubski, BSN RN OCN
role: PRINCIPAL_INVESTIGATOR
References: