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Clinical Trials/NCT05388214
NCT05388214
Recruiting
Not Applicable

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

University of Rochester1 site in 1 country40 target enrollmentMay 19, 2023
ConditionsCancer
InterventionsE-Co

Overview

Phase
Not Applicable
Intervention
E-Co
Conditions
Cancer
Sponsor
University of Rochester
Enrollment
40
Locations
1
Primary Endpoint
Feasibility of the intervention
Status
Recruiting
Last Updated
29 days ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 19, 2023
End Date
December 31, 2026
Last Updated
29 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kah Poh Loh

Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

University of Rochester

Eligibility Criteria

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#

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.

Arms & Interventions

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).

Intervention: E-Co

Outcomes

Primary Outcomes

Feasibility of the intervention

Time Frame: Post-intervention at week 12

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.

Secondary Outcomes

  • Controlled Oral Word Association (COWA)(Baseline and post-intervention at week 12)
  • Self-reported cognition(Baseline and post-intervention at week 12)
  • Cambridge Neuropsychological Test Automated Battery (CANTAB)(Baseline and post-intervention at week 12)
  • Hopkins Verbal Learning Test-Revised (HVLT-R)(Baseline and post-intervention at week 12)

Study Sites (1)

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