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.