Clinical trial NCT04230941: Memory and Attention Adaptation Training-Geriatrics (MAAT-G)
Official title: Mitigating Cancer-Related Cognitive Impairment in Older Adults With Breast Cancer Receiving Chemotherapy: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase I
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: 2020-01-18
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Usability
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 test usability of the intervention.

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 (phase I), 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 provided details pertain to Phase I of the study, which will focus on the adaptation process and usability testing.

Eligibility criteria: Patient Inclusion Criteria:

1. Have a diagnosis of invasive breast cancer
2. Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for breast cancer with two additional cycles remaining.
3. Be age 65 or older
4. Able to provide informed consent
5. 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)

Patient Exclusion Criteria:

1. Have surgery planned within 3 months of consent
2. 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
3. Patients with breast cancer receiving endocrine therapy as their only systemic therapy will not be eligible.

Eligible Caregiver Inclusion Criteria:

1. Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.

Eligible Caregiver Exclusion Criteria:

1. Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: Post-Intervention (up to 2 weeks)
measure: Experience Interview
timeFrame: Post-Intervention (up to 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Allison Magnuson
role: PRINCIPAL_INVESTIGATOR
References: