Evaluating Cognitive Changes on Patients in Chemotherapy (ECCPC)

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 9, 2025

Primary Completion Date

February 20, 2027

Study Completion Date

February 20, 2027

Conditions
Chemotherapy-related Cognitive Impairment
Interventions
BEHAVIORAL

Low-Intensity Walking Intervention

Participants in the experimental group will be asked to take part in a home-based, walking program. Each participant will receive a pedometer and will be instructed to increase their baseline daily step count by 100%. For example, if a participant typically walks 3,000 steps per day, they will be asked to increase their activity to 6,000 steps per day. Step counts will be regularly monitored, and participants will receive encouragement and support from study staff to help maintain adherence to the walking goals. In addition to the exercise intervention, participants in this group will undergo cognitive testing using the Montreal Cognitive Assessment (MoCA) at four timepoints: baseline, 6 months, 9 months, and 12 months. They will also complete self-reported questionnaires related to cognitive function at these same intervals. This group is designed to evaluate whether increased physical activity can improve or preserve cognitive function in patients undergoing chemotherapy.

BEHAVIORAL

Control Group Intervention

Participants in the control group will receive standard care and will not be given any specific exercise instructions. They will be provided with pedometers to track their daily steps, but they will not be asked to increase or change their usual level of physical activity. These participants will continue with their routine activities and cancer care as directed by their treating physicians. Like the intervention group, they will complete the Montreal Cognitive Assessment (MoCA) at baseline, 6 months, 9 months, and 12 months, as well as self-reported questionnaires about cognitive function at each timepoint. This group will serve as a comparator to determine the impact of the walking intervention on cognitive outcomes.

Trial Locations (1)

12308

Ellis Medicine/Roswell Park Medical Oncology, Schenectady

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ellis Medicine

OTHER