Exercise and Cognitive Rehab in Older Cancer Survivors
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
E-Co
BehavioralThe E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: E-CoExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-intervention at week 12Secondary outcomes
1
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.
Time frame
Baseline and post-intervention at week 122
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)
Time frame
Baseline and post-intervention at week 123
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.
Time frame
Baseline and post-intervention at week 124
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.
Time frame
Baseline and post-intervention at week 12Sponsors and contacts
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Source ClinicalTrials.gov