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Cognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL

Sponsor
Advocate Health Care (Other)
Overall Status
Unknown status
CT.gov ID
NCT03476226
Collaborator
(none)
100
Enrollment
6
Locations
2
Arms
21.4
Anticipated Duration (Months)
16.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cognitive Dysfunction Coping Strategy Teaching Sheet
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Nov 18, 2017
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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

Other: Cognitive Dysfunction Coping Strategy Teaching Sheet
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
No Intervention: Group 2

Provide current standard of education for cognitive dysfunction. QOL survey administered

Outcome Measures

Primary Outcome Measures

  1. FACT-Cog 3 questionnaire [16 weeks]

    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 Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Advocate Good Shepherd Hospital Barrington Illinois United States 60010
2 Advocate Illinois Masonic Medical Center Chicago Illinois United States 60657
3 Advocate Sherman Hospital Elgin Illinois United States 60123
4 Advocate South Suburban Hospital Hazel Crest Illinois United States 60429
5 Advocate Condell Medical Center Libertyville Illinois United States 60048
6 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068

Sponsors and Collaborators

  • Advocate Health Care

Investigators

  • Principal Investigator: Katharine L Szubski, BSN RN OCN, Advocate Health Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Advocate Health Care
ClinicalTrials.gov Identifier:
NCT03476226
Other Study ID Numbers:
  • 6727
First Posted:
Mar 26, 2018
Last Update Posted:
Mar 26, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Advocate Health Care
Quality of Life
Cognitive Dysfunction
Breast Cancer
Additional relevant MeSH terms:
Breast Neoplasms
Cognitive Dysfunction

Study Results

No Results Posted as of Mar 26, 2018