Health TrialsbyHealthPanel

Exercise and Cognitive Rehabilitation Interventions for Older Cancer Survivors

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Rochester

About this trial

The objective of this study is to assess the preliminary effects of an integrated exercise and cognitive rehabilitation intervention (ECO), an exercise intervention (EXCAP), and a cognitive rehabilitation intervention (MAAT) as compared to usual care on objective cognition (Trail Making Test).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥65 years (from date of consent, confirmed on the electronic medical record)

A diagnosis of any cancer

Have completed curative intent treatments

Patients on endocrine therapies are allowed to enroll

Disqualifiers

Any physical, psychological, or social impairments that would interfere with a patient's ability to participate in the study as determined by the patient's oncologist or their designee

Unwilling to complete study procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • EXCAP

    Behavioral

    The first component of the EXCAP exercise program is an individually tailored walking prescription and provides low to moderately intense aerobic exercise \[5-8 exercise rating of perceived exertion on the American College of Sports Medicine (ACSM) revised rating scale, which is a visual analog scale ranging from 1 = "Not tired at all" to 10 = "So tired, I can't go anymore"\] 7 days a week. This walking prescription will be developed and individually tailored for each patient based on step data reported by the patient. A Garmin activity tracker (a wearable sensor-based device) will be used to record the number of steps they walk daily during the 4-7 day baseline assessment. Patients will report their steps daily on a paper form, electronically via REDCap, or over the phone to the study staff at the end of the 4-7 day baseline assessment period. Alternatively, steps can also be obtained via the activity tracker by study staff.

  • MAAT

    Behavioral

    The MAAT intervention consists of 10 manualized workshops that will be delivered by a trained clinician. Patients will be provided with a workbook for skills practice in between sessions. A summary of workshop content is provided in Table 1. During Workshop #2, study staff or a trained clinician will provide patients with a link to a Vimeo video through the app. The Vimeo video has been created by the study team and guides patients through relaxation strategies to use before stressful events. Patients will be able to access the video without providing any personal information to the website.

  • ECO

    Behavioral

    Patients will receive the integrated EXCAP and MAAT interventions.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Exercise for Cancer Patients (EXCAP; Intervention)Experimental treatment 1 intervention
Group B: Memory and Attention Adaptation Training (MAAT; Intervention)Experimental treatment 1 intervention
Group C: Usual CareNo intervention 0 interventions
Group D: Exercise and Cognition (ECO; Intervention)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective cognition

Trail Making Test A \& B: The Trail Making Test assesses sustained attention. The Written Trail Making Test A \& B is preferred; however, if this is not feasible, the oral Trail Making Test will be utilized. There is not a range, lower scores indicating better performance

Time frame
Change from baseline to week 12

Secondary outcomes

1

Perceived Cognition

Functional Assessment of Cancer Therapy-Cognition Perceived Cognitive Abilities. Scores range from 0-28, higher scores are better.

Time frame
Change from baseline to week 12
2

Depressive symptoms

Center for Epidemiological Studies Depression Scale (CES-D): The CES-D is a 20-item depression scale developed and validated for use with various populations. Scores range from 0-60, higher scores are worst.

Time frame
Change from baseline to week 12
3

Anxiety symptoms

General Anxiety Disorder-7 (GAD-7): GAD-7 is a 7-item screening tool for anxiety. Scores range from 0-21, higher scores are worst.

Time frame
Change from baseline to week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Source ClinicalTrials.gov
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