Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT07390045
- Status
- Recruiting
Conditions
- Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- EXCAP — BEHAVIORALThe first component of the EXCAP exercise program is an individually tailored walking prescription and provides low to moderately intense aerobic exercise \[5-8 exercise rating of perceived exertion on the American College of Sports Medicine (ACSM) revised rating scale, which is a visual analog scale ranging from 1 = "Not tired at all" to 10 = "So tired, I can't go anymore"\] 7 days a week. This walking prescription will be developed and individually tailored for each patient based on step data reported by the patient. A Garmin activity tracker (a wearable sensor-based device) will be used to record the number of steps they walk daily during the 4-7 day baseline assessment. Patients will report their steps daily on a paper form, electronically via REDCap, or over the phone to the study staff at the end of the 4-7 day baseline assessment period. Alternatively, steps can also be obtained via the activity tracker by study staff.
- MAAT — BEHAVIORALThe MAAT intervention consists of 10 manualized workshops that will be delivered by a trained clinician. Patients will be provided with a workbook for skills practice in between sessions. A summary of workshop content is provided in Table 1. During Workshop #2, study staff or a trained clinician will provide patients with a link to a Vimeo video through the app. The Vimeo video has been created by the study team and guides patients through relaxation strategies to use before stressful events. Patients will be able to access the video without providing any personal information to the website.
- ECO — BEHAVIORALPatients will receive the integrated EXCAP and MAAT interventions.
Study Details
The objective of this study is to assess the preliminary effects of an integrated exercise and cognitive rehabilitation intervention (ECO), an exercise intervention (EXCAP), and a cognitive rehabilitation intervention (MAAT) as compared to usual care on objective cognition (Trail Making Test).
Key Dates
- Start date
- May 1, 2026
- Status verified
- May 2026
- Primary completion
- Mar 31, 2028
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Exercise for Cancer Patients (EXCAP; Intervention)Exercise for Cancer Patients (EXCAP) is an individually tailored, low-to-moderate intensity, home-based walking and progressive resistance exercise program designed for patients with cancer delivered by an exercise physiologist. It also includes digital health applications, allowing the tracking of exercise adherence, barriers to exercise, and symptoms.
- Experimental: Memory and Attention Adaptation Training (MAAT; Intervention)Memory and Attention Adaptation Training (MAAT) is an intervention based on cognitive behavioral therapy principles that integrates cognitive rehabilitation skills and provides education and training in adaptive behavioral coping skills, stress management techniques, and compensation strategies to address CRCD.
- No Intervention: Usual CarePatients in the control group will receive care as usual.
- Experimental: Exercise and Cognition (ECO; Intervention)Patients will receive the integrated EXCAP and MAAT interventions.
Primary Outcome Measure
Objective cognition [ Time Frame: Change from baseline to week 12 ]
Central Contacts
- Kah Poh Loh585-276-4353
- Becky Gravenstede585-727-4728
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 |
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