Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05864274 |
| Other study ID # |
IRB-300010880 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
August 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
Teresa K Boitano, MD |
| Phone |
2059344986 |
| Email |
tlboitano[@]uabmc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cancer-related cognitive impairment (CRCI), also known as "chemobrain," is the cognitive
decline that negatively impacts the majority of cancer patients undergoing chemotherapy,
radiation, and/or hormonal treatments. This application focuses on evaluating if using a
cognitive mobile training application can decrease the impact of CRCI in gynecologic oncology
patients through a multidisciplinary approach with patients undergoing assessments by our
neurocognitive team.
Description:
Cancer-related cognitive impairment (CRCI), also known as "chemobrain," is the cognitive
decline that negatively impacts the majority of cancer patients undergoing chemotherapy,
radiation, and/or hormonal treatments [1]. Occurring in the majority of patients receiving
cancer therapy, CRCI adverse events can, unfortunately, be lifelong and significantly affect
patients' quality of life [2-4]. Given the increased lifespan of gynecologic oncology cancer
patients due to the use of modern therapeutics, increased focus has been placed on evaluating
quality of life during and after treatments. CRCI, alternatively known as "chemo brain" or
"chemo fog" is a common side effect of cancer therapy. These symptoms frequently include
augmentation of clear thinking with memory difficulties that can are very distressing to
patients both during treatment and beyond. Despite effecting the majority of cancer patients,
CRCI data and research is underrepresented in the gynecologic oncology population. In breast
cancer, up to 77% of patient with breast cancer who received chemotherapy reported cognitive
symptoms associated with the therapy [9]. In a meta-analysis looking at patient with breast
cancer who were treated with chemotherapy, the most effected domains were processing speed
and language, executive function, and memory [10]. In general, a significant knowledge gap in
gynecologic oncology related CRCI exists as interventions to help improve this frequent and
life altering group of side effects have not been evaluated to date. Therefore, to our
knowledge, this proposal is the first of its kind in gynecologic oncology patients undergoing
cancer therapy.
In the dementia literature, mobile applications have been utilized in cognitive training
management to improve outcomes in patients [11-13]. Cognitive impairment (CI) is a precursor
to dementia and can be defined as mild and major. Mild CI does not yet interfere with
instrumental activities of daily living (IADLs) whereas major CI does [14]. In a recent
systematic review looking at interventions to delay age-related cognitive decline, it was
found that cognitive training and physical activity showed the most promise [15]. One
cognitive training application (CTA) showed improvement in cognitive ability following five,
fifteen-minute training applications a week for ten weeks [12]. Furthermore, a Cochrane
review showed that in a group of randomized non-pharmacologic interventions in women with
breast cancer, the use of cognitive training applications may reduce the risk of CRCI [16].
Unfortunately, no data currently exists on CTA use in gynecologic oncology patients. The goal
of this study is to evaluate the use of a CTA in gynecologic oncology patients undergoing
primary chemotherapy in order to reduce the impact of CRCI.
