Clinical trial NCT05570604: Computerized Cognitive Training in Breast Cancer Survivors
Official title: Computerized Cognitive Training in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cognitive Change
Cognitive Impairment
Quality of Life
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Indiana University
First posted: 2022-10-06
Enrollment: 46
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The purpose of this translational research is to conduct a home based single-blind, randomized controlled trial to test the feasibility, satisfaction, and preliminary efficacy of cognitive training compared to attention control in breast cancer survivors (BCS) as well as to explore potential biomarkers of intervention effects.
Primary purpose: SUPPORTIVE_CARE

Brief summary: For millions of cancer survivors, cognitive impairment is a prevalent, severe, and persistent problem that is associated with other symptoms (depressive symptoms, anxiety and fatigue), poorer work ability, and poorer quality of life. Available evidence, including work by the investigators own group, suggests that cognitive training may be a viable treatment option. However, to date, these studies are limited as none have been conducted in the home and therefore fail to address the transferability of these empirically based cognitive training programs to general practice.

The purpose of this translational research is to conduct a home based single-blind, randomized controlled trial to test the feasibility, satisfaction, and preliminary efficacy of cognitive training compared to attention control in breast cancer survivors (BCS) as well as to explore potential biomarkers of intervention effects.

This research innovatively builds on investigator's previous research by: 1) translating findings from the laboratory to the home setting and importantly seeks to identify facilitators and barriers of intervention use; 2) addresses limitations of previous trials (uses an attention control rather than a no-contact or wait-list control), (3) examines cognitive training effects on real-life outcomes such as associated symptoms, perceived work ability and quality of life; and (4) will be the first study in cancer survivors to explore levels of BDNF as a potentially sensitive outcome measure of intervention effects over time compared to attention control. Findings from this study will provide necessary information about the feasibility, satisfaction and preliminary efficacy of the home-based cognitive training on memory performance and processing speed as well as its effects on associated outcomes in BCS. Positive results will lead to a larger, full-scale study to determine efficacy and build evidence-based treatment for clinicians to use in treating BCS with cognitive impairment.

Detailed description: The goal of this translational research study is to determine the feasibility, satisfaction and preliminary efficacy of cognitive training delivered in the home for cancer survivors suffering from cancer- and cancer-treatment-related cognitive impairment. In addition, this will be the first study in cancer to explore levels of brain derived neurotrophic factor (BDNF), which is now known to be associated with neural plasticity, as a potentially sensitive outcome measure of intervention effects over time compared to attention control.

Cancer- and cancer-treatment-related cognitive impairment is a national research priority. Up to 75% of the 2.6 million breast cancer survivors (BCS) living in the United States report problems with memory or feelings of mental slowness. Deficits in memory and processing speed have also been documented on neuropsychological exam and functional magnetic resonance imaging (fMRI). Cognitive impairment is a prevalent, severe, and persistent problem that is associated with other symptoms (depressive symptoms, anxiety symptoms, fatigue), poorer work ability and poorer quality of life. Cognitive training may be a viable treatment option. To date, a total of 8 pilot studies, including the investigator's own randomized controlled trial36 have noted positive effects of cognitive training in cancer survivors. These findings, combined with evidence from studies in the well elderly, suggest that cognitive training interventions to promote neuroplasticity are likely to be beneficial; however, these studies are limited as most have been conducted in the home and therefore, fail to address the transferability of these cognitive training programs to general practice. Therefore, the purpose of this translational research is to conduct a home based single-blind, randomized controlled trial to test the feasibility, satisfaction, and preliminary efficacy of cognitive training delivered in the home setting compared to attention control in breast cancer survivors (BCS). In addition, this will be the first study in cancer to explore levels of brain derived neurotrophic factor (BDNF).

Specific aims are to: (1) examine the feasibility, acceptability (facilitators and barriers) and satisfaction of the computer-based cognitive training program; (2) test the preliminary efficacy of cognitive training on improving perceived cognitive function (FACT-PCI) over time compared to attention control; (3) test the preliminary efficacy of cognitive training on improving cognitive performance (memory, processing speed, attention, working memory, executive function) over time compared to attention control; Exploratory - (1) evaluate cognitive training effects on associated outcomes (work ability, health perception status and change and quality of life) compared to attention control; and (2) explore the effect of computerized cognitive training on serum brain derived neurotrophic factor (BDNF) over time compared to attention control. BDNF is widely distributed in the brain, plays a crucial role in neuroplasticity and has been observed to correlate with cognitive function in cancer patients. A total of 68 eligible BCS will be randomized to computerized cognitive training or attention control. A blinded and trained tester will perform data collection and neuropsychological testing at two time points: baseline prior to intervention (T1) and immediately after the 10-week cognitive training -program (within 90 days) (T2). Feasibility and satisfaction will be assessed through objective indicators (study adherence, completion rate) and self-report (facilitators, barriers, and perceived satisfaction) and cognitive performance will be assessed through objective neuropsychological tests of memory, processing speed, attention, working memory, executive function assessed over the phone. In addition, the study will measure the effects of cognitive training on self-report measures of perceived cognitive function, associated symptoms (depressive symptoms, anxiety and fatigue), perceived work ability, and quality of life. Data will be analyzed using descriptive statistics and a general linear mixed model (GLMM). Simple main effects analyses will be used to follow up statistically significant interactions.

Eligibility criteria: Inclusion Criteria:

1. Female gender
2. ≥ 21 years old at the time of informed consent
3. Ability to provide written informed consent and HIPAA authorization
4. First diagnosis of non-metastatic breast cancer.
5. Self-reported cognitive impairment
6. Subjects seeking treatment though not currently being treated or with prior treatment history for cognitive impairment.
7. ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy
8. Ability to understand, speak, read, and write English

Exclusion Criteria:

1. Comorbidities that would sufficiently impair performance or inhibit cognitive training such as: history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, or Alzheimers disease.
2. Cranial radiation or intrathecal therapy.
3. Current active major depression or substance abuse or history of bipolar disorder psychosis, schizophrenia, or learning disability.
4. History of current or other cancer except for basal cell skin cancer.

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Within 1 week post-intervention
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Concerns Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Work Ability Index (WAI) Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) General Perceptions of Health Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) Perceived Change in Health Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) General Mental Health Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
Other outcomes:
measure: Change in Rey Auditory Verbal Learning Test (Rey AVLT) Total Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Rey Auditory Verbal Learning Test (Rey AVLT) Delayed Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Rivermead Behavioral Paragraph Recall Test Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Rivermead Behavioral Paragraph Recall Test -Delayed Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Symbol Digit Modalities Test [SDMT], Oral Response Version Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Digit Span, Total Raw Score From the WAIS-III Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Controlled Oral Word Association (COWA) Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
measure: Change in Serum Levels of Brain-Derived Neurotropic Factor (BDNF) Between Baseline and 1 Week Post-intervention
timeFrame: Baseline and within 1 week post-intervention
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Nursing
state: Indiana
Study officials:
affiliation: Ohio State University College of Nursing.
name: Diane Von Ah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University College of Nursing
name: Tina Opoku, BS
role: STUDY_DIRECTOR
References: