Exercise and Cognitive Rehab in Older Cancer Survivors (E-Co)

An Exercise and COgnitive Rehabilitation Intervention for Older Cancer Survivors (The E-Co Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Behavioral: E-Co

Detailed Description

Cancer survivors (i.e., those who completed cancer-directed treatment) often experience long-term treatment-related effects, such as cancer-related cognitive decline (CRCD). Exercise and cognitive rehabilitation (rehab) interventions have been shown to improve CRCD symptoms in both cancer and non-cancer populations. Among older adults without cancer, studies have also demonstrated that multicomponent interventions combining exercise and cognitive rehab are more effective in improving cognitive dysfunction than either intervention alone. However, exercise adherence and self-efficacy are lower in older adults compared to younger adults, and combined interventions may be too demanding for older cancer survivors. Therefore, innovative ways are needed to integrate an exercise program within the context of a cognitive rehab program to increase exercise adherence and self-efficacy, and ultimately improve CRCD symptoms through a streamlined multicomponent intervention.

In this study, the investigators propose to refine a multicomponent Exercise and COgnitive rehab intervention (E-Co) and assess its feasibility in older cancer survivors.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kah Poh Loh; Phone Number: 585-276-4353; Email: Kahpoh_Loh@URMC.Rochester.edu
• Study Contact Backup: Name: Allison Magnuson; Phone Number: 585 - 275 - 5823; Email: mailto:allison_magnuson@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Kah Poh Loh; Phone Number: 585-276-4353; Email: Kahpoh_Loh@URMC.Rochester.edu
      • Principal Investigator: Kah Poh Loh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-Co; 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; The E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported cognition	Functional Assessment of Cancer Therapy-Cognition (FACT-Cog): The FACT-Cog is a validated patient reported outcome measure created to assess cognitive challenges identified by patients with cancer. It has 37 items and has four domains in Perceived Cognitive Impairments (PCI), Impact of PCI on Quality of Life, Comments from Others, and Perceived Cognitive Abilities. Score ranges from 0-148, higher score indicates better self-reported cognition.	Baseline and post-intervention at week 12
Cambridge Neuropsychological Test Automated Battery (CANTAB)	The CANTAB Delayed Matching to Sample assesses both simultaneous visual matching ability and short-term visual recognition memory, for non-verbalisable patterns. The subject is shown a complex visual pattern, followed by four similar patterns after a brief delay. The subject must select the pattern which exactly matches the sample. Better speed of response and higher number of correct patterns indicate better health outcomes. (Patients only)	Baseline and post-intervention at week 12
Controlled Oral Word Association (COWA)	The Controlled Oral Word Association (COWA) tool is a measure of verbal fluency evaluating expressive language and executive function. Subjects are asked to freely generate as many words as they can that start with one of the prompted letters ("C", "F", and "L") in the span of one minute. Greater numbers of words indicate better health outcomes.	Baseline and post-intervention at week 12
Hopkins Verbal Learning Test-Revised (HVLT-R)	The Hopkins Verbal Learning Test-Revised (HVLT-R) tool is a test of verbal learning and memory. Researchers read a list of 12 words to subjects and ask them to report as many of the words as they can recall. The reporting period is timed. Higher numbers of correctly remembered words, along with lower reporting times, are indicative of better health outcomes.	Baseline and post-intervention at week 12

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: geriatric oncology, cancer survivors, exercise, cognitive rehabilitation, cognition
• Other Study ID Numbers: UOCPC22022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.
• IPD Sharing Time Frame: The data will be available for 7 years after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No