Behaviors and Mental Disorders

All Conditions

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Dyadic Life Review will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes.

DLR will consist of 8 sessions delivered by a trained licensed clinician (i.e, the PI or other trained clinician) via video-conferencing in weekly sessions of 60 minutes. Each session will facilitate a recall of each phase of life: childhood, adolescence, young adulthood, mid-life, earlier later life, and later life. While together, the patient and caregiver will each be asked structured questions to prompt reminiscence of memories from that phase of life.

Dyadic Life Review (DLR)

Lee Kehoe, PhD

The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with caregivers of older adults with advanced cancer, including those with Mild Cognitive Impairment (MCI). The study will enroll 20 dyads of caregivers and older patients with advanced cancer and 20 dyads of caregivers and patients with advanced cancer and Mild Cognitive Impairment (MCI).

Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers

Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers

The scale of this instrument ranges from 0 to 10 with higher scores indicating more loneliness.

This measures the quality of the relationship with the care-receiver: assesses quality of relationship between participant and family member and has demonstrated valid scores across several relationship types, including spouses and other family members. The scale of this instrument ranges from 1 to 7 with higher scores indicating more closeness.

PROMIS29 assesses for seven domains of depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles. The scale of each domain of the instrument ranges from with 0-10 with higher scores indicating worse outcomes.

Measure the degree to which situations are appraised as stressful. This scale ranges from 0-40 with higher scores indicating higher perceived stress.

Items assess both positive and negative aspects of caregiving, have been shown to be responsive to intervention. Subscales: role captivity, overload, relational deprivation, competence, personal gain, family beliefs, family conflict, job conflict. The scale ranges from 0 to 24 with higher scores indicating a more negative caregiver experience.

The purpose of this scale is to identify the clinical threshold of depression in older adults. The scale ranges from 0 to 15 with higher scores indicating worse depression.

This tool is a 10-point self-report measure to capture distress and identify a list of sources of that distress. The scale ranges from 0-10 with higher scores indicating more distress.

This is a 7-item measure to assess relationship quality that ranges from 0-36 with higher scores indicating positive relationship quality.

This is an 18-item measure to assess individual's perceptions of received and provided support. The scale ranges from 0-145 with higher scores indicating better dyadic coping.

Distress will be measured for patients and caregivers using the Distress Thermometer and Problem list tool. This tool is a 10-point self-report measure to capture distress and identify a list of sources of that distress. The scale ranges from 0-10 with higher scores indicating more distress. The change in the correlation of the scores between patients and caregivers will be calculated.

National Cancer Institute (NCI)

National Institute on Aging (NIA)

University of Rochester

Research Assistant Professor

Neoplasms

Skin and Connective Tissue Diseases

Substance Related Disorders

Breast Neoplasms

Chemotherapy-Related Cognitive Impairment

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals being measured and logged. Data will be uploaded on a secure cloud server to which clinicians will have access.

Participants will perform web-based game play while wearing sham equipment. Duration of sessions will be fixed and frequency of sessions will equal that of the experimental group training. Over the total training the control group will have an equal duration of training with the experimental group.

Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals and subjective pain level being measured and logged.

They will wear a computer system modified with biosensors, then do motor and cognitive baselines. Subsequently, participants will play an increasing number of games, targeted at cognitive domains of executive function (primary), memory and attention. At the end of every session vitals and subjective pain will be measured and logged.

Clinical Coordinator will call homes weekly to ascertain general health and issues with participation.

At the end of week 4 and 8 participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire to gauge perceived benefits and technical difficulties when using the experimental system. Questions will be scored on a 5-point Likert scale.

Telerehabilitation Experimental Group

Sham control group will train playing web games while wearing a biosensor connected to a laptop provided, showing the web games. However biosensor data will not be used to control game difficulty.

Sham group controls will start every session with vitals and subjective pain levels being measured and logged. Then participants will play the same frequency and duration of sessions, however those will consist of web games training the same domains (memory, focusing, executive function). Interaction will be through a mouse, and data will be downloaded to a server maintained by the company doing the web games. Data will then be transferred to the research team.

At the end of every session vitals and subjective pain levels will again be measured and logged.

Once a week the Clinical Coordinator will call the home to ascertain general health and determine is there were issues with that week participation.

Telerehabilitation Sham Control Group

Grigore C Burdea, PhD

Edward A Burde, MS

Jasdeep Hundal, PsyD

Daniel Valdivia, M.S.

Edward A Berde, MS

Develop a game-based upper-extremity motor and cognitive rehabilitation system using custom and adaptable virtual reality simulations on a wearable device enhanced with biosensors.

Participants are stage II and stage III breast cancer survivors with lasting cognitive impairments following their first round of chemotherapy. They will be randomized 1:1 into an experimental group and a sham control group. Each group will train in the home for 8 weeks, during which they will perform up to 4 rehabilitation sessions/week (based on tolerance). Each session will start with vitals being measured and logged. Each group will have three clinical evaluations: 1) at baseline; 2) at 8 weeks post-baseline; and 3) at 16 weeks from baseline for follow up.

Experimental group sessions will consist of increasingly more difficult cognitive training tasks in the form of simulated tasks. Biosensors will be sampled while participants interact with these games while wearing the computer system.

Sham control group will have the same number, suration and frequency of sessions, however they will play web games while wearing some the same biosensors.

Caregivers of all subjects will receive a laptop to be used in filling subjective evaluation forms and sending messages to research team. Training will be in the home, so caregivers will need to support the trials by ensuring compliance with the protocol.

All subjects will undergo standardized clinical evaluations at baseline, at 8 weeks and at 16 weeks from baseline. The subjects in the experimental group will have computerized measures taken during each session, and will fill subjective evaluation forms every 4 weeks of active training.

This portion of the study is intended to provide information pertaining to the feasibility of the experimental system for remote integrative (cognitive and motor) therapy of breast cancer survivors (Stage II or III) with lasting cognitive impairments subsequent to their first chemotherapy regimen, and living in the community with a caregiver.

We aim primarily at determining any clinical benefits in improved cognition (primarily in the executive functions domain), but also increased independence in ADLs, and improved mood (reduced depression). Another outcome is the degree of technology acceptance by the targeted population. Training will be done in the home, thus co-dwelling caregivers will also be recruited.

Specific aims are:

1. testing of a wearable device modified with added biosensors, by breast cancer survivors with CRCI.
2. new technology acceptance and ease of use at home by these individuals;
3. clinical benefit to improved cognition (primarily executive functions and cognitive endurance) when experimental therapy is added to daily routine vs. daily routine plus web-based cognitive games;
4. a therapist console module and enhanced automatic session report that will allow remote monitoring of patient exercising and offline data processing and review.

Participants will be randomized equally in an experimental group, or a sham control group. Experimental subjects will receive computer-based therapy, of increasing duration and intensity for up to 4 sessions/week for 8 weeks. The length of sessions will increase from 15 minutes in week 1 to 40 minutes of actual play in week 8. The longer sessions will also train cognitive endurance, or the ability for sustained cognitive effort. All experimental subjects will have their exercise duration and intensity data logged into the database and investigators will monitor them remotely. An Artificial Intelligence (AI) software layer in the system will progress game difficulty based on success in the games as well as on degree of cognitive engagement, as estimated by the biosensors. Higher cognitive difficulty will be indicative of improved cognition, thus progress in mitigating cognitive impairments subsequent to chemotherapy. Additionally, the duration of training will also be logged, as will be the frequency of training. Longer sessions will be indicative of ability to sustain cognitive engagement longer. Additional input will be obtained from caregivers in the form of periodic questionnaires.

Fatigue will be self-reported during weekly follow up calls by a Clinical Coordinator. Participants will train while seated, and (if needed) their arms can be supported on a table. Rest periods may be introduced as needed, to further mitigate fatigue.

At the end of every other week participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire aimed at gauging perceived benefits and possible technical difficulties when using the BrightGo system. Questions will be scored on a 5-point Likert scale.

Control group will perform an equal amount of web-based game play of assigned cognitive-oriented games.

All participants will undergo screening for cognitive impairments (to confirm Mild Cognitive Impairment at baseline). Then they will continue with their daily routine during their 8-week training, and will undergo a second clinical evaluation at the end of these 8 weeks. All participants will then undergo a third (follow up) evaluation at 8 weeks post-end of training.

Caregivers will support the training by helping ensure compliance to protocol, and will complete subjective evaluation forms to rate the perceive benefit of training for the person they care for.

All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues.

Feasibility Sham comparison study:

Participants are randomized equally into the experimental group and a sham control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.

Outcomes Assessor will not be told which group the participant is part of, so not be biased in evaluations.

Only female will be recruited, as this study targets breast cancer survivors.

Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study

Home-based Virtual Reality System for the Treatment of Chemotherapy-related Cognitive Impairments - Feasibility Study

Data will be anonymized and made available through scientific publications.

Form used at screening post-consent to determine a participant's propensity for simulation sickness \[Freiwald et al., 2020\]. The questionnaire asks participants 26 questions The first 13 questions ascertain the general heath and fitness of the subject, and have Yes/No answers The remaining 13 questions are score on a on a 5 point Likert scale, with five point Likert scales, referring to the frequency of each complaint's occurrence. These scales range from 0 to 4 with the labels "very rarely", "rarely", "occasionally", "frequently" and "very often".

Heart rate (Pulse) measured with a medical meter at start and end of each training session

Blood pressure (systolic and diastolic) measured with a medical meter at start and end of each training session

Measure of change in cognitive impairment for cancer survivors and their caregivers

Measure cognitive ability \[Pearson Education 2017\]

Measure of sustained attention \[Hartman 2006\]

Measure of word generation \[White and Stern 2003\]

A measure of executive functioning \[Raitan 1958\]

Verbal/auditory memory test \[Brandt 1991\];

Visual memory test \[Benedict et al., 1996\];

Quality of Life for Cancer Patients \[Ferrell, et al 2012\]. Form includes 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being.

Each question is scored on a 0 to 10 scale.

Questionnaire for caregiver oncology quality of life \[Weitzner et al 1999\]

Measure of depression severity \[Beck 1996\]

measure of upper extremity range of motion

Objective measure of participant performance in the therapeutic games.

subjective evaluation on a Likert scale of system and perceived benefits by participant and by caregiver

measure of skin conductance (indicative of sweat) as an indirect indication of cognitive engagement, blinking rate and gaze.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers	NCT05200572	Cancer, Advance... Cognitive Impai...	Dyadic Life Rev...	50 Years -	University of Rochester
Telerehabilitation Cognitive Impairments Following Chemotherapy Feasibility Study	NCT04972019	Cognitive Impai...	Telerehabilitat... Telerehabilitat...	20 Years - 65 Years	Bright Cloud International Corp
Study of a Behavioral Intervention for Older Advanced Cancer Patients and Their Caregivers	NCT05200572	Cancer, Advance... Cognitive Impai...	Dyadic Life Rev...	50 Years -	University of Rochester

Spots Global Cancer Trial Database for cognitive impairment, mild