Cancer-related Problem/Condition, Cognitive Impairment
Conditions
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.
Interventions
BEHAVIORALMAAT-G
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.
BEHAVIORALSupportive 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.
Sponsors
National Institute on Aging (NIA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of the Controlled Oral Word Association (COWA) Tool | Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks). | 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) |
| Mean of the Hopkins Verbal Learning Test-Revised (HVLT-R) | Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks). | 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) |
| Mean of the Geriatric Depression Screen (GDS) | Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks). | 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) |
| 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) | Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks). | 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. |
| Mean of the Instrumental Activities of Daily Living (IADL) | Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks). | 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) |
| Experience Interview - Proportion of Patients Who Expressed Perceived Benefit From Workshops. | Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks). | Semi-structured interview with patients about experience with workshop sessions - proportion of patients who expressed perceived benefit from workshops. |
| Mean of the Generalized Anxiety and Depression 7-item Scale (GAD-7) | Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks). | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 36 |
| MAAT-G Intervention 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
MAAT-G: 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. | 34 |
| Caregivers Patients in this study had the option to enroll a caregiver. | 2 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | Supportive Therapy (Time and Attention Control) | MAAT-G Intervention | Caregivers | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 34 Participants | 2 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 31 Participants | 2 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 31 Participants | 2 Participants | 64 Participants |
| Sex: Female, Male Female | 36 Participants | 34 Participants | 1 Participants | 71 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 | 0 / 2 |
| other Total, other adverse events | 1 / 36 | 1 / 34 | 0 / 2 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 | 0 / 2 |
Outcome results
Primary
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.
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: Two members of the ST population opted not to respond to the FACT-COG survey. Caregiver data was not collected for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Therapy (Time and Attention Control) | Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG) | 155.8 score on a scale | Standard Deviation 29 |
| MAAT-G Intervention | Mean of the Functional Assessment of Cancer Therapy-Cognition (FACT-COG) | 152.7 score on a scale | Standard Deviation 27.9 |
Secondary
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.
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: Only 29 patients from each group (ST and MAAT-G) were selected; some patients did not allow the interview to be audiorecorded thus it was not included in the qualitative coding, thus the denominator for each group is less than in previous outcome measures. Caregiver data was not collected for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Therapy (Time and Attention Control) | Experience Interview - Proportion of Patients Who Expressed Perceived Benefit From Workshops. | 16 Participants |
| MAAT-G Intervention | Experience Interview - Proportion of Patients Who Expressed Perceived Benefit From Workshops. | 28 Participants |
Secondary
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.
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: The study population missing did not have access to the technology required to complete the CANTAB, resulting in only 59 patients total rather than the 64 enrolled. CANTAB data for caregivers was not collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Supportive Therapy (Time and Attention Control) | 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) | 4.04 correct patterns | Standard Error 0.17 |
| MAAT-G Intervention | 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) | 4.10 correct patterns | Standard Error 0.16 |
Secondary
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)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: Two members of the ST population opted not to respond to the COWA survey. Caregiver data was not collected for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Therapy (Time and Attention Control) | Mean of the Controlled Oral Word Association (COWA) Tool | 12.4 words generated | Standard Deviation 3.4 |
| MAAT-G Intervention | Mean of the Controlled Oral Word Association (COWA) Tool | 11.4 words generated | Standard Deviation 3.2 |
Secondary
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)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: Two members of the ST population opted not to respond to the GAD-7 survey. Caregiver data was not collected for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Therapy (Time and Attention Control) | Mean of the Generalized Anxiety and Depression 7-item Scale (GAD-7) | 3.4 score on a scale | Standard Deviation 4.9 |
| MAAT-G Intervention | Mean of the Generalized Anxiety and Depression 7-item Scale (GAD-7) | 4 score on a scale | Standard Deviation 4 |
Secondary
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)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: Two members of the ST population opted not to respond to the GDS survey. Caregiver data was not collected for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Therapy (Time and Attention Control) | Mean of the Geriatric Depression Screen (GDS) | 2.3 score on a scale | Standard Deviation 2.2 |
| MAAT-G Intervention | Mean of the Geriatric Depression Screen (GDS) | 3.3 score on a scale | Standard Deviation 2.4 |
Secondary
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)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: Two members of the ST population opted not to respond to the HVLT-R survey. Caregiver data was not collected for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Therapy (Time and Attention Control) | Mean of the Hopkins Verbal Learning Test-Revised (HVLT-R) | 8 words recalled | Standard Deviation 1.8 |
| MAAT-G Intervention | Mean of the Hopkins Verbal Learning Test-Revised (HVLT-R) | 7.7 words recalled | Standard Deviation 1.7 |
Secondary
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)
Time frame: Within four weeks of intervention completion, the intervention window was 10 weeks plus or minus 2 weeks (8 to 12 weeks).
Population: Two members of the ST population opted not to respond to the IADL survey. Caregiver data was not collected for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Therapy (Time and Attention Control) | Mean of the Instrumental Activities of Daily Living (IADL) | 12.8 score on a scale | Standard Deviation 2 |
| MAAT-G Intervention | Mean of the Instrumental Activities of Daily Living (IADL) | 12.9 score on a scale | Standard Deviation 1.7 |