Exercise and Cognitive Rehab in Older Cancer Survivors

NCT05388214 | Suspended DMC

• 1 other identifier: UOCPC22022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the feasibility of a combined mobile health exercise and cognitive rehabilitation intervention and its effect on cognition in a single-arm pilot study that recruits cancer survivors.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of the intervention

  Feasibility is defined based on adherence to the intervention components: 1) At least 70% of patients provide exercise data on 50% on the intervention days; and 2) At least 70% of patients attend at least 8/10 of the MAAT-G workshops.

  Post-intervention at week 12

Secondary Outcomes (4)

• Self-reported cognition

  Baseline and post-intervention at week 12

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Baseline and post-intervention at week 12

• Controlled Oral Word Association (COWA)

  Baseline and post-intervention at week 12

• Hopkins Verbal Learning Test-Revised (HVLT-R)

  Baseline and post-intervention at week 12

Study Arms (1)

E-Co

EXPERIMENTAL

The E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G).

Behavioral: E-Co

Interventions

E-Co BEHAVIORAL

The E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G).

E-Co

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years at the time of consent
• Have 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 as long as they have completed curative-intent treatment
• Have concerns about memory or other thinking abilities following cancer treatment\*
• English speaking (because the interventions are available in English language only)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• No medical contraindications for exercise per oncologist#
• Able to walk 4 meters#
• Able to provide informed consent#
• (\*) Confirmed by asking the patient (#) Confirmed through eligibility confirmation with the patient's oncologist or their designee

You may not qualify if:

• Physical, psychological, or social impairments that would interfere with patient's ability to participate in the study or participate in the intervention, as determined by the PIs and oncology team.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kah Poh Loh

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based cognitive rehab intervention developed to address CRCD in older adults with cancer and is delivered over the course of 10 individual workshops with a trained health professional. MAAT-G focuses on an individual's psychological response to injury as compared to the biological events triggering cognitive dysfunction, and provides education and training in adaptive behavioral coping skills, stress management techniques, and compensation strategies. Geriatric Oncology-Exercise for Cancer Patients (GO-EXCAP) leverages a mobile app to deliver an individually tailored, low-to-moderate intensity, home-based walking and progressive resistance exercise program designed for patients with cancer, tailored to their physical capacity. The E-Co intervention will integrate components of GO-EXCAP into MAAT-G.

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 24, 2022
• Study Start: May 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

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)