Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Cognitive Dysfunction

Breast Diseases

Skin Diseases

Quality of Life

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.

Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.

The person is asked to clear the rows of blocks presented on the screen, either by moving them into horizontal or vertical blocks that have identical color. The goal is to refine and increase the response of primary visual cortex neurons and to enable the person to increase speed and accuracy of visual processing (executive function) and visual memory.

Sweep Seeker

The user is first presented with a target bird. Subsequently, a group of birds is presented in the peripheral vision and then disappears when the trial begins. The user selects the section of the screen where the target bird appeared. The presentation speed adapts with user performance (i.e. better performance = faster presentation). The goal is to improve speed and accuracy of object identification in peripheral vision and improve visual precision important for improving memory.

Bird Safari

The person is first presented objects (jewels) on the screen. The objects are then covered with occluders (bubbles) and then identical distracters are presented. The objects move around in screen and when the movement stops, the user chooses the occluders that cover the jewels. The number of jewels adapts to performance (more jewels = better performance). The goal is to improve divided visual attention, sustained visual attention, visual working memory, and visual precision.

Jewel Diver

The person is presented a series of target stimuli and distracters which are presented at one time and then disappear. The locations of the stimuli are marked by icons, and the user chooses the icons where the target stimuli were once located. The goal is to increase speed and accuracy as well as the ability to extract information accurately.

Master Gardener

The person is presented with a target vehicle briefly in both the center of the screen and in one of eight locations in the periphery. Two vehicles are then presented briefly in the center of the screen, one of which is the target vehicle. The user must identify the location of the target vehicle in the periphery as well as identify which was the target vehicle that appeared in the center. The goal of this activity is to improve divided attention and ability to extract information and discard irrelevant information from peripheral vision.

Road Tour

The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.

Computerized Crossword Puzzles

Diane Von Ah, PhD

Tina Opoku, BS

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.

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.

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.

A blinded and trained tester will perform data collection and neuropsychological testing at two time points

Computerized Cognitive Training in Breast Cancer Survivors

Measure of learning and episodic memory. List of 15 words given and asked to recall, score range from 0-15. Higher scores indicate better outcomes.

Measure of delayed memory. List of 15 words given and asked to recall at delayed timeframe, score range from 0-15. Higher scores indicate better outcomes.

Measure of immediate memory. 14-item test with score range from 0-12. Higher scores indicate better outcomes.

Measure of delayed memory. 14-item test with score range from 0-12. Higher scores indicate better outcomes.

Measure of speed of processing. 90 seconds to pair numbers and figures, score range 0-110. Higher scores indicate better outcomes.

Measure of attention and working memory. Repetition of number sequence, score range from 0-15. Higher scores indicate better outcomes.

Measure of verbal/executive functioning. Provide a spontaneous list of words within 60 seconds, score range from 0-60. Higher scores indicate better outcomes.

Plasma levels of BDNF were measured in duplicate by ELISA (catalog number DBD00; R\&D Systems, Minneapolis, MN). The minimum detectable level of BDNF in this assay is 20 pg/ ml, and the within-assay variation is 4.2% at 1339 pg/ml. Higher levels indicate higher concentrations of BDNF (reported in pg/ml).

Likert-based 8-item questionnaire rating overall satisfaction, quality of training, etc. 4-point scale (range from 8-32) with higher scores indicating greater acceptability and satisfaction.

Perceived Cognitive Impairment (PCI) measured using 8-item, 5-point Likert scales with range from 8-40. The Cognitive Abilities Scale items target positive self-assessments of cognitive functioning with higher scores indicating better cognitive ability. The Cognitive Concerns Scale items are worded negatively and express concerns in the same area with higher scores indicating more cognitive concerns.

Work ability was assessed by one item from the WAI. This item assessed current work ability on a Likert scale from 1 (cannot work at all) to 10 (work ability at its best) with higher scores indicating better work ability.

General Health Perception and Quality of life (general mental health) was measured using The MOS-SF-36 with the general perceptions of health status subscale used to measure general health perceptions (5 items), changes in general health perception (1-item), and general mental health (5-items), on a 5-point Likert scale (total range of 11-55), with higher scores indicating positive perceptions of general health and general mental health.

Indiana University

Ohio State University

Distinguished Professor of Cancer Research, College of Nursing Director of Cancer Research Center for Healthy Aging, Self-Management and Complex Care

Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control

Participants assigned to the exercise group (HIIT), will receive an exercise bike and have 3 weekly supervised exercise training sessions for four (4) months/16weeks.

Participants can choose to participate in the exercise sessions at home via zoom or in clinic.

Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post High-Intensity Intervals Training (HIIT) tests and four (4) month follow up test and receive 3 MRIs over the span of 9 months.

Participants will be randomized into one of two groups: High-Intensity Intervals Training (HIIT) or Attention Control

Participants assigned to the Attention Control group, will receive instruction on a 16 week home-based stretching program.

Participants will have two (2) baseline tests, one (1) midpoint test, two (2) post home-based stretching program tests and receive 3 MRIs over the span of 9 months.

At the end of the 16-week home-based stretching program, participants will be provided the option to participate in the High-Intensity Intervals Training (HIIT) program.

16 week exercise program with stationary bike.

High-Intensity Intervals Training

Attention Control

Christina Dieli-Conwright, MD

Mary Norris, MS

The purpose of this research is to determine whether a 16-week high intensity interval training (HIIT) exercise program will improve brain health among women undergoing chemotherapy and also improve cardiovascular (heart) function.

The names of the study interventions involved in this study are/is:

* High-Intensity Interval Training (HIIT)

This research study is a randomized controlled pilot trial that will compare an exercise group to a control group on brain health, cardiac fitness and overall quality of life in breast cancer patients starting chemotherapy either before (pre-operative or neoadjuvant) or after surgery (post-operative or adjuvant)

This research study is a Pilot Study, which is the first-time investigators are examining this intervention in this setting. The study is trying to determine whether participating in a specific exercise program can improve brain and heart function, as there is some evidence that there can be cognitive changes after chemotherapy among some patients with breast cancer. This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for breast cancer.

Participants will be randomly assigned to one of two groups:

* Group A: High Intensity Interval Training (HIIT) for 16 weeks
* Group B: Attention Control for 16 weeks home-based stretching; the HIIT intervention will be available after the study ends

The research study procedures include screening for eligibility and study treatment including extensive evaluations of your fitness and brain health, including MRI, blood tests, bone scans, fitness and strength assessments, and surveys at study entry and follow up visits.

Participants will receive study treatment for 4 months and will be followed for 4 months.

The total time for participation in this study will be about 8 months.

It is expected that about 30 people will take part in this research study.

The American Institute for Cancer Research is supporting this research by providing funding for the study.

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy

Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy (The CLARITY Trial)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Assess executive functioning of High-Intensity Interval Training (HIIT) to attention controls participants using the Flanker test.

Assess global cognition of High-Intensity Interval Training (HIIT) to attention controls participants using the Montreal Cognitive assessment.

Assess working memory of High-Intensity Interval Training (HIIT) to attention controls participants using the Digital Symbol and Trials test

Assess episodic memory of High-Intensity Interval Training (HIIT) to attention controls participants using the complex figure diagram copy test

Assess semantic fluency of High-Intensity Interval Training (HIIT) to attention controls participants using the category fluency test

Assess resting state connectivity and DTI connectivity through functional magnetic resonance imaging (fMRI)

Cardiorespiratory fitness will be measured through a VO2 max test

American Institute for Cancer Research

Dana-Farber Cancer Institute

Principal Investigator

Substance Related Disorders

Digestive System Diseases

Chemotherapy-Related Cognitive Impairment

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Joseph McCollom, DO

Emily Powell, PHD

Dr Joseph McCollom, DO

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

All self representation of gender identity accepted

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment.

Indiana University School of Medicine

Joseph McCollom

Oncologist

Head and Neck Neoplasms

ritual training program for 8 weeks, biweekly

Ritual training program including education and demonstration

Ritual training program

Routine care

To evaluate the effects of a ritual training program in head and neck cancer (HNC) patients.

The purpose of this study will to evaluate the effects of a ritual training program on disfigurement, self-esteem, social interaction, and body image in head and neck cancer (HNC) patients.

A prospective, repeated measures, randomized controlled therapeutic intervention design was employed. The experimental group will receive a ritual training program, and the control group will receive routine care. Patients will be assessed at three time points: baseline assessment (T0), and then at 1, 2, and 3-months (T1, T2, and T3) after participating in the ritual training program or routine care.

Ritual Training Program in HNC Patients

Effects of a Ritual Training Program in the Head and Neck Cancer Patients: A Randomized Controlled Trial

Observer-rated disfigurement scale (1-9, higher score indicating greater levels of self-esteem higher disfigurement)

Body Image Scale (0-30, higher scores indicate greater symptoms or distress in terms of body image concerns)

Liebowitz Social Anxiety Scale(0-72, higher scores indicate greater fear or avoidance social interaction

Hospital Anxiety and Depression Scale-Depression Subscale (0-21, higher score indicates a higher level of depression).

Rosenberg Self-Esteem Scale(10-40, higher scores indicating greater levels of self-esteem)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Computerized Cognitive Training in Breast Cancer Survivors	NCT05570604	Breast Cancer Cognitive Chang... Cognitive Impai... Quality of Life	Sweep Seeker Bird Safari Jewel Diver Master Gardener Road Tour Computerized Cr...	21 Years -	Ohio State University
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy	NCT04724499	Breast Cancer Chemotherapy Ef... Exercise Therap... Cognitive Chang...	High-Intensity ... Attention Contr...	18 Years -	Dana-Farber Cancer Institute
Computerized Cognitive Training in Breast Cancer Survivors	NCT05570604	Breast Cancer Cognitive Chang... Cognitive Impai... Quality of Life	Sweep Seeker Bird Safari Jewel Diver Master Gardener Road Tour Computerized Cr...	21 Years -	Ohio State University
Computerized Cognitive Training in Breast Cancer Survivors	NCT05570604	Breast Cancer Cognitive Chang... Cognitive Impai... Quality of Life	Sweep Seeker Bird Safari Jewel Diver Master Gardener Road Tour Computerized Cr...	21 Years -	Ohio State University
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy	NCT05014399	Neoplasm, Color... Cognitive Impai... Cognitive Dysfu... Cognitive Chang... Chemo-brain Chemo Fog Chemotherapy Ef... Cognitive Decli...		18 Years -	Parkview Health
Ritual Training Program in HNC Patients	NCT03346564	Education Cognitive Chang...	Ritual training... Routine care	20 Years - 70 Years	Ministry of Science and Technology, Taiwan
Computerized Cognitive Training in Breast Cancer Survivors	NCT05570604	Breast Cancer Cognitive Chang... Cognitive Impai... Quality of Life	Sweep Seeker Bird Safari Jewel Diver Master Gardener Road Tour Computerized Cr...	21 Years -	Ohio State University
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy	NCT05014399	Neoplasm, Color... Cognitive Impai... Cognitive Dysfu... Cognitive Chang... Chemo-brain Chemo Fog Chemotherapy Ef... Cognitive Decli...		18 Years -	Parkview Health
Improving Cognitive Function Through High-intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy	NCT04724499	Breast Cancer Chemotherapy Ef... Exercise Therap... Cognitive Chang...	High-Intensity ... Attention Contr...	18 Years -	Dana-Farber Cancer Institute
Ritual Training Program in HNC Patients	NCT03346564	Education Cognitive Chang...	Ritual training... Routine care	20 Years - 70 Years	Ministry of Science and Technology, Taiwan

Spots Global Cancer Trial Database for cognitive change