Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors

NCT07390045 | Not Yet Recruiting DMC

• 1 other identifier: UOCPC26001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cancer

Keywords

geriatric oncology; cancer survivors; exercise; cognitive rehabilitation; cognition

Outcome Measures

Primary Outcomes (1)

• Objective cognition

  Trail Making Test A \& B: The Trail Making Test assesses sustained attention. The Written Trail Making Test A \& B is preferred; however, if this is not feasible, the oral Trail Making Test will be utilized. There is not a range, lower scores indicating better performance

  Change from baseline to week 12

Secondary Outcomes (3)

• Perceived Cognition

  Change from baseline to week 12

• Depressive symptoms

  Change from baseline to week 12

• Anxiety symptoms

  Change from baseline to week 12

Study Arms (4)

Exercise for Cancer Patients (EXCAP; Intervention)

EXPERIMENTAL

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.

Behavioral: EXCAP

Memory and Attention Adaptation Training (MAAT; Intervention)

EXPERIMENTAL

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.

Behavioral: MAAT

Usual Care

NO INTERVENTION

Patients in the control group will receive care as usual.

Exercise and Cognition (ECO; Intervention)

EXPERIMENTAL

Patients will receive the integrated EXCAP and MAAT interventions.

Behavioral: ECO

Interventions

EXCAP BEHAVIORAL

The 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.

Exercise for Cancer Patients (EXCAP; Intervention)

MAAT BEHAVIORAL

The 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.

Memory and Attention Adaptation Training (MAAT; Intervention)

ECO BEHAVIORAL

Patients will receive the integrated EXCAP and MAAT interventions.

Exercise and Cognition (ECO; Intervention)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years (from date of consent, confirmed on the electronic medical record)
• A diagnosis of any cancer
• Have completed curative intent treatments
• Patients on endocrine therapies are allowed to enroll
• Patients with hematologic malignancies after autologous or allogeneic stem cell transplant are allowed to enroll if they have completed curative-intent treatment
• Answered "yes" to the verbal question "Do you have concerns about memory or other thinking abilities following your cancer treatment?"
• Able to speak English (interventions are available in English only)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3#
• No medical contraindications to exercise#
• Able to walk 4 meters#
• Able to provide informed consent#
• Confirmed through eligibility confirmation with the patient's oncologist or their designee

You may not qualify if:

• Any physical, psychological, or social impairments that would interfere with a patient's ability to participate in the study as determined by the patient's oncologist or their designee
• Unwilling to complete study procedures

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Loh KP, Sanapala C, Watson EE, Jensen-Battaglia M, Janelsins MC, Klepin HD, Schnall R, Culakova E, Vertino P, Susiarjo M, Lin PJ, Mendler JH, Liesveld JL, Huselton EJ, Taberner K, Mohile SG, Mustian K. A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. Blood Adv. 2022 Jul 12;6(13):3850-3860. doi: 10.1182/bloodadvances.2022007056.

  PMID: 35320340 BACKGROUND

• Loh KP, Sanapala C, Janelsins M, Klepin HD, Schnall R, Culakova E, Sohn MB, Vertino P, Susiarjo M, Jensen-Battaglia M, Becker MW, Liesveld J, Mendler JH, Huselton E, Lin PJ, Mustian K. Protocol for a pilot randomized controlled trial of a mobile health exercise intervention for older patients with myeloid neoplasms (GO-EXCAP 2). J Geriatr Oncol. 2022 May;13(4):545-553. doi: 10.1016/j.jgo.2021.12.011. Epub 2021 Dec 21.

  PMID: 34949540 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kah Poh Loh

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kah Poh Loh

CONTACT

585-276-4353; Kahpoh_Loh@URMC.Rochester.edu

Becky Gravenstede

CONTACT

585-727-4728; becky_gravenstede@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available for 7 years after study completion

Locations

US (1)