Clinical trial NCT05388214: Exercise and Cognitive Rehab in Older Cancer Survivors
Official title: An Exercise and COgnitive Rehabilitation Intervention for Older Cancer Survivors (The E-Co Study)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cancer
Keywords: geriatric oncology, cancer survivors, exercise, cognitive rehabilitation, cognition
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Post-intervention at week 12
Secondary outcomes:
measure: Self-reported cognition
timeFrame: Baseline and post-intervention at week 12
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Baseline and post-intervention at week 12
measure: Controlled Oral Word Association (COWA)
timeFrame: Baseline and post-intervention at week 12
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Baseline and post-intervention at week 12
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kah Poh Loh
role: PRINCIPAL_INVESTIGATOR
References: