Clinical trial NCT04669301: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase II
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Cognitive Impairment
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-16
Enrollment: 85
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Functional Assessment of Cancer Therapy-Cognition (FACT-COG)
timeFrame: Within four weeks of intervention completion
Secondary outcomes:
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: Within four weeks of intervention completion
measure: Controlled Oral Word Association (COWA)
timeFrame: Within four weeks of intervention completion
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Within four weeks of intervention completion
measure: Geriatric Depression Screen (GDS)
timeFrame: Within four weeks of intervention completion
measure: Generalized Anxiety and Depression 7-item scale (GAD-7)
timeFrame: Within four weeks of intervention completion
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Within four weeks of intervention completion
measure: Experience Interview
timeFrame: Within four weeks of intervention completion
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Allison Magnuson, DO
role: PRINCIPAL_INVESTIGATOR
References: