Cognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-18

Study Completion Date

2019-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)

NCT04213365

Breast Cancer

COMPLETED NA

Relationships Among Cognitive Function, Lifestyle, and Exercise After Cancer Treatment

NCT02523677

Breast Cancer Cognitive Impairment

COMPLETED

Metacognitive Strategy Training in Cancer-related Cognitive Impairment

NCT05505045

Breast Cancer Female

COMPLETED NA

Examining a Common Complaint of Women Who Receive Chemotherapy for Breast Cancer- Cognitive Difficulty

NCT01553097

Breast Cancer Neurocognitive Impairment Quality of Life

COMPLETED

Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress

NCT01264562

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Cognitive Dysfunction Coping Strategy Teaching Sheet

Intervention Type OTHER

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 2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes