NCT03476226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 4, 2024

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

March 1, 2018

Last Update Submit

October 2, 2024

Conditions

Breast Cancer

Keywords

Quality of LifeCognitive DysfunctionBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    16 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

NO INTERVENTION

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

Interventions

Cognitive Dysfunction Coping Strategy Teaching SheetOTHER

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

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010, United States

Location

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

Advocate Sherman Hospital

Elgin, Illinois, 60123, United States

Location

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429, United States

Location

Advocate Condell Medical Center

Libertyville, Illinois, 60048, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Katharine L Szubski, BSN RN OCN

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 26, 2018

Study Start

November 18, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 4, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(6)