Improve Cancer-related Cognitive Impairment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Using a Novel Mobile Cognitive Training Application to Improve Cancer-related Cognitive Impairment in Gynecologic Oncology Patients

Conditions
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Gynecologic Cancer, Chemotherapy Effect, Chemo-brain, Cancer-related Cognitive Difficulties

Intervention / Treatment
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* Behavioral: Cognitive training application


Participation Criteria
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Eligibility Criteria
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Inclusion criteria are: newly diagnosed gynecologic malignancy (uterine, cervical, ovarian, primary peritoneal, vulvar, or vaginal) and undergoing chemotherapy own a smartphone or tablet with ability to download cognitive training application and age >21 years old Exclusion criteria include: medical diagnosis of dementia significant underlying mental diagnoses for which they are on more than 1 medication for (patients with depression or anxiety on single-agent therapy will be able to participate age <21

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: OBSERVATION<br>PATIENTS WILL PARTICIPATE IN THE NEUROPSYCHOLOGY EVALUATION BUT WILL NOT USE THE COGNITIVE MOBILE TRAINING APPLICATION. | |
| Experimental: MOBILE COGNITIVE TRAINING APP<br>These patients will undergo neuropsychology evaluation and use the cognitive mobile training application | Behavioral: Cognitive training application<br>* Patients will participate with a cognitive training application and undergo neurocognitive testing during and after chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive function | Evaluated by the NIH Toolbox of Assessment of Neurologic Behavioral Function | From initiation of chemotherapy through 2 years | 
| Neurocognitive function | Evaluated by the FACT-Cog survey | From initiation of chemotherapy through 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHEMOTHERAPY SIDE EFFECTS, GYNECOLOGIC CANCERS, CHEMO-BRAIN, CANCER-RELATED COGNITIVE IMPAIRMENT