Back to resultsCognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Dysfunction Coping Strategy Teaching Sheet
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Quality of Life, Cognitive Dysfunction, Breast Cancer
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).
Sites / Locations
- Advocate Good Shepherd Hospital
- Advocate Illinois Masonic Medical Center
- Advocate Sherman Hospital
- Advocate South Suburban Hospital
- Advocate Condell Medical Center
- Advocate Lutheran General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1
Group 2
Arm 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
Provide current standard of education for cognitive dysfunction. QOL survey administered
Outcomes
Primary Outcome Measures
FACT-Cog 3 questionnaire
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03476226
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advocate Health Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Quality of Life, Cognitive Dysfunction, Breast Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm 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
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
Provide current standard of education for cognitive dysfunction. QOL survey administered
Intervention Type
Other
Intervention Name(s)
Cognitive Dysfunction Coping Strategy Teaching Sheet
Intervention Description
Demographic sheet, Fact-Cog3, and teaching tool at baseline then week 4 and 8 Fact Cog3 and reinforcement of tool, at week 16 evaluation and Fact-Cog3
Primary Outcome Measure Information:
Title
FACT-Cog 3 questionnaire
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine L Szubski, BSN RN OCN
Organizational Affiliation
Advocate Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Good Shepherd Hospital
City
Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Advocate Sherman Hospital
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Facility Name
Advocate South Suburban Hospital
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429
Country
United States
Facility Name
Advocate Condell Medical Center
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Cognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL
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