CancerE-CoNCT05388214
Exercise and Cognitive Rehab in Older Cancer Survivors
A study testing E-Co in people with Cancer, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- E-Co
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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*
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Kah Poh Loh, (585) 276-4353, Kahpoh_Loh@URMC.Rochester.edu
Kah Poh Loh
About this study
Official title: An Exercise and COgnitive Rehabilitation Intervention for Older Cancer Survivors (The E-Co Study)
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- E-Co
- Keywords
- geriatric oncology, cancer survivors, exercise, cognitive rehabilitation, cognition
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-CoBehavioural
The E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G).
| Study group | Role | What they receive |
|---|---|---|
| E-Co | Experimental | The E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G). Receives: Behavioral: E-Co |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention at week 12
Secondary outcomes (4)
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.
Measured: Baseline and post-intervention at week 12
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)
Measured: Baseline and post-intervention at week 12
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.
Measured: Baseline and post-intervention at week 12
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.
Measured: Baseline and post-intervention at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start19 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kah Poh Loh, University of Rochester
- Investigators
- Kah Poh Loh, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388214
- Sponsor's protocol ID
- UOCPC22022
- Acronym
- E-Co
- Status last verified
- Jul 2026
- First submitted
- 18 May 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise and COgnitive Rehabilitation Intervention for Older Cancer Survivors (The E-Co Study)
- ClinicalTrials.gov ID
- NCT05388214
- Acronym / sponsor ID
- E-Co / UOCPC22022
- Conditions
- Cancer
- Keywords
- geriatric oncology, cancer survivors, exercise, cognitive rehabilitation, cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| E-Co | Experimental | Behavioral: E-CoThe E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥60 years at the time of consent
- Have a diagnosis of any cancer
- Have completed curative intent treatments
- Have concerns about memory or other thinking abilities following cancer treatment*
- English speaking (because the interventions are available in English language only)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-CoThe E-Co intervention will integrate active components of a mobile health exercise intervention (GO-EXCAP) into a cognitive rehabilitation intervention (MAAT-G). | Behavioural | E-Co |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kah Poh Loh principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Co in people with Cancer, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kah Poh Loh (585-276-4353, Kahpoh_Loh@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: Post-intervention at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.