Breast CancerNCT03476226
Cognitive Dysfunction and Breast Cancer Coping Strategies Impact on QOL
A study testing Cognitive Dysfunction Coping Strategy Teaching Sheet in people with Breast Cancer, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive Dysfunction Coping Strategy Teaching Sheet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Nov 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Advocate Sherman Hospital
Elgin, Illinois, 60123
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Advocate Condell Medical Center
Libertyville, Illinois, 60048
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Cognitive Dysfunction Coping Strategy Teaching Sheet
- Keywords
- Quality of Life, Cognitive Dysfunction, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Cognitive Dysfunction Coping Strategy Teaching Sheet |
| Group 2 | No intervention | Provide current standard of education for cognitive dysfunction. QOL survey administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start18 Nov 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharine L Szubski, BSN RN OCN, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476226
- Sponsor's protocol ID
- 6727
- Status last verified
- May 2023
- First submitted
- 1 Mar 2018
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03476226
- Acronym / sponsor ID
- 6727
- Conditions
- Breast Cancer
- Keywords
- Quality of Life, Cognitive Dysfunction, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Cognitive Dysfunction Coping Strategy Teaching SheetThe 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 2 | No intervention | –Provide current standard of education for cognitive dysfunction. QOL survey administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Dysfunction Coping Strategy Teaching SheetDemographic 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 | Other | Group 1 |
Primary outcome
FACT-Cog 3 questionnaire
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine L Szubski, BSN RN OCN principal investigator
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Dysfunction Coping Strategy Teaching Sheet in people with Breast Cancer, run by Wake Forest University Health Sciences at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-Cog 3 questionnaire (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.