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Recruiting NCT05388214

Exercise and Cognitive Rehab in Older Cancer Survivors

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: E-Co.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Feasibility of the intervention [Time frame: Post-intervention at week 12]
Secondary outcome measures (4)
  • Self-reported cognition [Time frame: Baseline and post-intervention at week 12]
  • Cambridge Neuropsychological Test Automated Battery (CANTAB) [Time frame: Baseline and post-intervention at week 12]
  • Controlled Oral Word Association (COWA) [Time frame: Baseline and post-intervention at week 12]
  • Hopkins Verbal Learning Test-Revised (HVLT-R) [Time frame: Baseline and post-intervention at week 12]

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#
  • Able to provide informed consent#

(\*) Confirmed by asking the patient (#) Confirmed through eligibility confirmation with the patient's oncologist or their designee

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Rochester — Rochester

Identifiers

NCT: NCT05388214 · UOCPC22022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗