Cognitive Impairment Clinical Trial
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
Verified date | November 2023 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4 |
Est. completion date | February 1, 2022 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | System Usability Scale (SUS) | The System Usability Scale is a metric to evaluate the usability of the intervention (Patients) and is scored 0 (minimum) to 100 (maximum). Higher scores indicate greater usability. A mean score >68 is consisted with optimal usability. | Post-Intervention (up to 2 weeks) | |
Primary | Experience Interview | Semi-structured interview with patients and caregivers about experience with MAAT-G. (Patients and caregivers) Qualitative Analysis of transcripts from participant/caregiver interviews will be analyzed for themes on intervention benefit and barriers and facilitators. | Post-Intervention (up to 2 weeks) |
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