Cancer-related Problem/ConditionNCT04669301
Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase II
A study testing MAAT-G in people with Cancer-related Problem/Condition and Cognitive Impairment, run by University of Rochester at 1 site in United States.
Trial summary
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer-related Problem/Condition, Cognitive Impairment
- What is being tested?
- MAAT-G
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2021to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Have a diagnosis of invasive breast cancer
- Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for breast cancer with two additional cycles remaining.
- Be age 65 or older
- Able to provide informed consent
- Able to read and understand English (or possess a designated health care proxy that can do the same that was designated prior to the patient losing decision-making capabilities)
Who cannot join
- Have surgery planned within 3 months of consent
- Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent
- Patients with breast cancer receiving endocrine therapy as their only systemic therapy will not be eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitigating Cancer-Related Cognitive Impairment in Older Adults With Breast Cancer Receiving Chemotherapy: Memory and Attention Adaptation Training-Geriatrics (MAAT-G): A Randomized Pilot Study
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and subsequently test the ability of MAAT to improve or maintain cognition for older adults with breast cancer receiving adjuvant chemotherapy.
Read the detailed description
Cancer-related cognitive dysfunction (CRCD) is a significant problem, affecting up to 75% of patients receiving chemotherapy. Older adults are at greater risk of developing CRCD which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising tool that improves perceived cognition in younger cancer survivors with CRCD. For older adults with cancer, MAAT could be delivered alongside chemotherapy to mitigate the development of CRCD (when risk is highest) and CRCD-related effects on functional independence for older adults. However, MAAT will require adaptation to meet the unique needs of older adults to optimize usability and efficacy for this population. The overarching goal of this project is to adapt MAAT for older adults using input from patient and caregiver stakeholders, and subsequently gather data on the preliminary effects of the adapted MAAT (MAAT-Geriatrics [G]) on perceived cognition, objective cognitive measures and functional independence. The investigators will adapt and refine MAAT-G using feedback from key stakeholders through iterative testing of MAAT-G with 85 patient-caregiver dyads. The research plan combines the use of standardized quantitative measures of cognition and functional independence with semi-structured interviews (mixed methods), so that data from both can be integrated to optimize the adaptation and to gain a better understanding of MAAT-G's effects that are not fully captured by traditional quantitative measures alone.
- Being tested
- MAAT-G, Supportive therapy (time and attention control)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAAT-GBehavioural
Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
Supportive therapy (time and attention control)Behavioural
Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing.
| Study group | Role | What they receive |
|---|---|---|
| Supportive therapy (time and attention control) | Active comparator | Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing. Receives: Behavioral: Supportive therapy (time and attention control) |
| MAAT-G intervention | Experimental | The MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study Receives: Behavioral: MAAT-G |
| Caregivers | No intervention | Patients on this study had the option to enroll a caregiver. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG)
The Functional Assessment of Cancer Therapy-Cognition tool is a 50-question tool that evaluates memory and mental function in the past 7 days. The range of scores for the tool are 0 to 200 with higher scores generally indicating worse health outcomes.
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Secondary outcomes (7)
Least Squares Mean for Delay Match to Sample Total Correct at the 12-second Delay (DMSTC-12) From the 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-verbalizable patterns. The subject is shown a complex visual pattern, followed by four similar patterns after a brief delay. The subject must select the pattern that exactly matches the sample. Better speed of response and a higher number of correct patterns indicate better health outcomes. (Patients only) The least squares mean for the variable Delay Match to Sample Total Correct at the 12-second delay (DMSTC-12) is analyzed.
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Controlled Oral Word Association (COWA) Tool
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. (Patients only)
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the 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. (Patients only)
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Geriatric Depression Screen (GDS)
The Geriatric Depression Screen (GDS) tool is a 15 question psychological assessment with "yes" or "no" answers (ranging from 0 to 15, with a higher score indicating more depression). The questions pertain to emotional state and vary between positive and negative presentation. (Patients only)
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Generalized Anxiety and Depression 7-item Scale (GAD-7)
The Generalized Anxiety and Depression 7-item scale (GAD-7) is a 7-item question tool that evaluates feelings of anxiety over the previous 2 weeks. Each question is ranked from 0 to 3, with higher scores indicating worse health outcomes (the range for the survey is 0-21). (Patients only)
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Instrumental Activities of Daily Living (IADL)
The Instrumental Activities of Daily Living (IADL) tool asks questions about functional independence. There are 7 questions on scale of most to least independence. The range of this scale is 3 to 21, with a higher score indicating less independence. (Patients only)
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Experience Interview - Proportion of Patients Who Expressed Perceived Benefit From Workshops.
Semi-structured interview with patients about experience with workshop sessions - proportion of patients who expressed perceived benefit from workshops.
Measured: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start2 Apr 2021
- Primary completion17 Apr 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer-related Problem/ConditionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Allison Magnuson, University of Rochester
- Investigators
- Allison Magnuson, DO, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669301
- Sponsor's protocol ID
- UCCS20127
- Other IDs
- K76AG064394
- Status last verified
- Jun 2025
- First submitted
- 5 Dec 2020
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Cancer-Related Cognitive Impairment in Older Adults With Breast Cancer Receiving Chemotherapy: Memory and Attention Adaptation Training-Geriatrics (MAAT-G): A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04669301
- Acronym / sponsor ID
- UCCS20127
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and subsequently test the ability of MAAT to improve or maintain cognition for older adults with breast cancer receiving adjuvant chemotherapy.
Detailed description
Cancer-related cognitive dysfunction (CRCD) is a significant problem, affecting up to 75% of patients receiving chemotherapy. Older adults are at greater risk of developing CRCD which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising tool that improves perceived cognition in younger cancer survivors with CRCD. For older adults with cancer, MAAT could be delivered alongside chemotherapy to mitigate the development of CRCD (when risk is highest) and CRCD-related effects on functional independence for older adults. However, MAAT will require adaptation to meet the unique needs of older adults to optimize usability and efficacy for this population. The overarching goal of this project is to adapt MAAT for older adults using input from patient and caregiver stakeholders, and subsequently gather data on the preliminary effects of the adapted MAAT (MAAT-Geriatrics [G]) on perceived cognition, objective cognitive measures and functional independence. The investigators will adapt and refine MAAT-G using feedback from key stakeholders through iterative testing of MAAT-G with 85 patient-caregiver dyads. The research plan combines the use of standardized quantitative measures of cognition and functional independence with semi-structured interviews (mixed methods), so that data from both can be integrated to optimize the adaptation and to gain a better understanding of MAAT-G's effects that are not fully captured by traditional quantitative measures alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supportive therapy (time and attention control) | Active comparator | Behavioral: Supportive therapy (time and attention control)Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing. |
| MAAT-G intervention | Experimental | Behavioral: MAAT-GThe MAAT-G intervention will be delivered by a trained psychology fellow at the University of Rochester Medical Center. The intervention will be delivered through televideoconferencing and participants will be provided a tablet equipped with a HIPPA compliant televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of Rochester Zoom application which is HIPPA compliant. A tablet instruction manual will be given to patients to help guide them through how to use a tablet and how to navigate the Zoom application. A unique meeting ID number will be given to each patient to log in to the Zoom application. If participants do not have access to wireless internet, the tablet will be equipped with a data package for participant use for the purposes of this study |
| Caregivers | No intervention | –Patients on this study had the option to enroll a caregiver. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of invasive breast cancer
- Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for breast cancer with two additional cycles remaining.
- Be age 65 or older
- Able to provide informed consent
- Able to read and understand English (or possess a designated health care proxy that can do the same that was designated prior to the patient losing decision-making capabilities)
Key exclusion criteria (3 listed)
- Have surgery planned within 3 months of consent
- Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent
- Patients with breast cancer receiving endocrine therapy as their only systemic therapy will not be eligible.
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 |
|---|---|---|
| MAAT-GMemory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies. | Behavioural | MAAT-G intervention |
| Supportive therapy (time and attention control)Supportive Therapy (ST) is a "behavioral placebo" and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing. | Behavioural | Supportive therapy (time and attention control) |
Primary outcome
Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
The Functional Assessment of Cancer Therapy-Cognition tool is a 50-question tool that evaluates memory and mental function in the past 7 days. The range of scores for the tool are 0 to 200 with higher scores generally indicating worse health outcomes.
7 secondary outcomes
Least Squares Mean for Delay Match to Sample Total Correct at the 12-second Delay (DMSTC-12) From the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Controlled Oral Word Association (COWA) Tool
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Geriatric Depression Screen (GDS)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Generalized Anxiety and Depression 7-item Scale (GAD-7)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Mean of the Instrumental Activities of Daily Living (IADL)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Experience Interview - Proportion of Patients Who Expressed Perceived Benefit From Workshops.
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Allison Magnuson, DO 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 MAAT-G in people with Cancer-related Problem/Condition and Cognitive Impairment, 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG) (time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).). 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 15 Jul 2025.