Breast Cancer Female
Conditions
Keywords
cancer, metacognition, cognition, Telehealth, activities of daily living
Brief summary
The first aim of this study is to determine the feasibility of delivering CO-OP remotely to breast cancer survivors, who self-report cancer-related cognitive impairment (CRCI), in preparation for a future R01 trial. The second aim of this study is to assess the effect of CO-OP on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI. The research team hypothesizes that effect size estimations will indicate that CO-OP will have a greater positive effect, compared to attention control, on activity performance, subjective and objective cognition, and quality of life in a sample of breast cancer survivors who self-report CRCI.
Detailed description
Breast cancer survivors often self-report cognitive changes after treatment for cancer (e.g. cancer-related cognitive impairment (CRCI)). These cognitive changes have a devastating impact on everyday life activities, such as work/productivity, community involvement, driving, and financial management. While CRCI would likely be amenable to rehabilitation services, breast cancer survivors face two primary barriers to adequate rehabilitation, including (1) inadequate access to rehabilitation services, and (2) limited effective interventions to address CRCI. Breast cancer survivors have inadequate access to rehabilitation services to address CRCI. A recent report sponsored by the National Cancer Institute (NCI) concluded that most NCI-designated cancer centers do not have integrated cancer rehabilitation services. Even if comprehensive rehabilitation services were provided by these centers, millions of cancer survivors live in rural areas outside close proximity to a cancer center and are more likely to experience poorer outcomes compared to urban counterparts. If rehabilitation services were provided, proximity to facilities may be a limiting factor in individuals from rural communities receiving rehabilitative care. Access to services has been further curtailed amid the COVID-19 pandemic, with calls building from national organizations for improvements in remote delivery of services. Metacognitive strategy training (MCST) is a practice standard to address cognitive impairment in other conditions, such as traumatic brain injury and stroke. The Cognitive-Orientation to daily Occupational Performance (CO-OP) approach is a MCST intervention in which subjects are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to engage in an activity. The investigators' preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, and quality of life in breast cancer survivors with CRCI. While current evidence supports the remote delivery of strategy-based interventions like CO-OP, this intervention has not been evaluated in breast cancer survivors with CRCI. The investigators' overall research hypothesis is that CO-OP can feasibly be administered remotely and will improve activity performance, subjective and objective cognition, and subjective quality of life in breast cancer survivors with CRCI.
Interventions
BEHAVIORALCO-OP Procedures
CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, we introduce the approach to the subject and teach the global cognitive strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this strategy is used as the main problem-solving framework to facilitate skill acquisition.The subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal.
BEHAVIORALAttention Control Procedures
Individuals in the attention control group will have dose-equivalent, weekly virtual contact through the Zoom platform for 12-weeks with a a trained interventionist not involved in CO-OP treatment. The control group will control for interpersonal interaction, maturation effects, and testing effects. The focus of each session will include: (1) social interaction characterized by warmth/empathy and (2) provision of usual care CRCI educational resources (e.g. exercise, using memory aids, minimizing distractions) from MD Anderson Cancer Center. These recommendations will be provided without further instruction. Any questions that arise regarding CRCI the subject is experiencing will be answered. The therapist will debrief with the subject on any changes in CRCI symptoms. The content and duration of each call will be tracked. Each session will be recorded with two randomly selected and reviewed for fidelity.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All outcomes assessors will be blinded to participant study group assignment.
Intervention model description
After baseline assessment, subjects will be randomized to one of two groups: (1) a 10-session Cognitive Orientation to daily Occupational Performance (CO-OP) intervention; or (2) a 10-session attention control group.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* self-reported CRCI (Cognitive Failures Questionnaire (CFQ) score \>30) * completed full course of chemotherapy at least 6 months, but no later than 3 years, prior to participation * able to read, write, and speak English fluently * able to provide valid informed consent * have a life expectancy of greater than 6 months at time of enrollment * diagnosed with breast cancer (invasive ductal or lobular BrCA Stages I, II, or III) and completed chemotherapy within the preceding three years * on stable doses of medications (i.e., no changes in past 60 days)
Exclusion criteria
* prior cancer diagnoses of other sites with evidence of active disease within the past year * active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain function (e.g., Parkinson's disease, dementia, cerebral infarcts, traumatic brain injury) * severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction | After study completion, an average of 14 weeks | Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction. |
| Telehealth Usability Questionnaire (TUQ) | After study completion, an average of 14 weeks | Measure of telehealth usability from participant's perspective. Specifically, the TUQ measures usefulness and utility of technologies including usefulness, ease of use, effectiveness, reliability, and satisfaction. The TUQ uses a self-report Likert scale of 1 (disagree) to 7 (agree). |
| Acceptability of Intervention Measure (AIM) | After study completion, an average of 14 weeks | Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) |
| Intervention Appropriateness Measure (IAM) | After study completion, an average of 14 weeks | Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) |
| Feasibility of Intervention Measure (FIM) | After study completion, an average of 14 weeks | Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) |
| Canadian Occupational Performance Measure (COPM) Trained Goal Performance | Pre-intervention (week 0) and post-intervention (week 14) | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. |
| NeuroQoL Cognitive Function Short Form | Pre-intervention (week 0) and post-intervention (week 14) | Self-report measure of cognitive ability in daily life activity. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). The total raw score range is 8-40. The t-score is reported with a mean of 50 and standard deviation of 10. Higher scores mean fewer perceived cognitive challenges. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest | Pre-intervention (week 0) and post-intervention (week 14) | Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of Number/Letter switching. Age-adjusted scale scores with a mean of 10 and standard deviation of 3 are reported. The total range of scores is 1-19. Higher scores indicate better performance. |
| Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Pre-intervention (week 0) and post-intervention (week 14) | Objective measure of cognitive performance. The Letter-Number subtest measures working memory. The Coding and Symbol Search subtest measure processing speed. Higher scores indicate better cognitive performance. Age adjusted scaled scores with a mean of 10 and standard deviation of 3 are reported. Range of reported scores is 1 to 19. |
| Brief Visuospatial Memory Test -Revised Trial 1 | Pre-intervention (week 0) and post-intervention (week 14) | Objective measure of episodic memory. Participant is presented with six geometric figures for 10 seconds on three different occasions, and then asked to draw the six figures on a separate sheet of paper in the correct order. Increased errors may indicate challenges with episodic memory. T-scores are reported with a mean of 50 and standard deviation of 10. Higher scores indicate better performance. |
| Paced Auditory Serial Addition Test | Pre-intervention (week 0) and post-intervention (week 14) | Objective measure of working memory. Participant is presented with single digits every 2 seconds and asked to add each digit to the one immediately prior to it. Total score is out of 60 points, with increased errors indicating challenges with working memory. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities | Pre-intervention (week 0) and post-intervention (week 14) | Self-report measure of ability to participate in social roles and activities. Higher scores reflect higher abilities. T-scores are reported with a mean of 50 and a standard deviation of 10. |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) | Pre-intervention (week 0) and post-intervention (week 14) | Self-report measure of quality of life for breast cancer survivors. Domains include questions related to physical, emotional, social, and functional well-being, as well as additional concerns. Minimum = 0 (not at all), Maximum = 4 (very much). The range of scores is 0 to 148. Higher scores indicate decreased perceived well-being and quality of life. |
Countries
United States
Participant flow
Recruitment details
Dates of the recruitment period: September 2022-December 2023 Types of recruitment: Local cancer registry, cancer support groups, newsletters, social media posts (Facebook, Instagram, Twitter), flyers in the community.
Pre-assignment details
One participant was enrolled and signed written consent but withdrew during baseline assessment. Therefore, this participant was never randomized.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) Each CO-OP session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
CO-OP Procedures: CO-OP is a metacognitive strategy training intervention that will be used in this study. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, we introduce the approach to the subject and teach the global cognitive strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this strategy is used as the main problem-solving framework to facilitate skill acquisition.The subject identifies a GOAL, and then is guided by the therapist to discover a PLAN to potentially achieve the goal. The subject is then asked to DO the plan (if feasible during the therapy session otherwise asked to complete at home prior to the next treatment session), and subsequently to CHECK to see if the plan worked, i.e. the goal was achieved. This process is repeated until satisfactory performance is met for each established goal. | 21 |
| Attention Control Group Each session will last 60 minutes and subjects will complete one session per week over the course of 10 weeks. All sessions will be delivered remotely via the Zoom platform.
Attention Control Procedures: Individuals in the attention control group will have dose-equivalent, weekly virtual contact through the Zoom platform for 12-weeks with a a trained interventionist not involved in CO-OP treatment. The control group will control for interpersonal interaction, maturation effects, and testing effects. The focus of each session will include: (1) social interaction characterized by warmth/empathy and (2) provision of usual care CRCI educational resources (e.g. exercise, using memory aids, minimizing distractions) from MD Anderson Cancer Center. These recommendations will be provided without further instruction. Any questions that arise regarding CRCI the subject is experiencing will be answered. The therapist will debrief with the subject on any changes in CRCI symptoms. The content and duration of each call will be tracked. Each session will be recorded with two randomly selected and reviewed for fidelity. | 21 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Attention Control Group | Total | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 10.6 | 53.9 years STANDARD_DEVIATION 10 | 52.8 years STANDARD_DEVIATION 9.7 |
| Breast cancer stage Invasive Ductal Stage 1 | 8 Participants | 14 Participants | 6 Participants |
| Breast cancer stage Invasive Ductal Stage 2 | 7 Participants | 12 Participants | 5 Participants |
| Breast cancer stage Invasive Ductal Stage 3 | 4 Participants | 10 Participants | 6 Participants |
| Breast cancer stage Invasive Lobular Stage 1 | 0 Participants | 2 Participants | 2 Participants |
| Breast cancer stage Invasive Lobular Stage 2 | 1 Participants | 2 Participants | 1 Participants |
| Breast cancer stage Invasive Lobular Stage 3 | 1 Participants | 2 Participants | 1 Participants |
| Chemotherapy length | 6.4 months STANDARD_DEVIATION 4.3 | 6.2 months STANDARD_DEVIATION 4.4 | 5.9 months STANDARD_DEVIATION 4.6 |
| Education | 16.0 years STANDARD_DEVIATION 2.7 | 15.9 years STANDARD_DEVIATION 2.5 | 15.9 years STANDARD_DEVIATION 2.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 40 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hormonal therapies No | 6 Participants | 12 Participants | 6 Participants |
| Hormonal therapies Yes | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 37 Participants | 20 Participants |
| Radiation No | 8 Participants | 18 Participants | 10 Participants |
| Radiation Yes | 13 Participants | 24 Participants | 11 Participants |
| Region of Enrollment United States | 21 participants | 42 participants | 21 participants |
| Sex: Female, Male Female | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time post chemotherapy | 22.9 months STANDARD_DEVIATION 9.8 | 21.2 months STANDARD_DEVIATION 9.4 | 19.6 months STANDARD_DEVIATION 8.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 3 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
Acceptability of Intervention Measure (AIM)
Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Acceptability of Intervention Measure (AIM) | 4.58 units on a scale | Standard Deviation 0.55 |
| Attention Control Group | Acceptability of Intervention Measure (AIM) | 4.25 units on a scale | Standard Deviation 0.58 |
Primary
Canadian Occupational Performance Measure (COPM) Trained Goal Performance
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Canadian Occupational Performance Measure (COPM) Trained Goal Performance | Baseline | 4.4 units on a scale | Standard Deviation 1.3 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Canadian Occupational Performance Measure (COPM) Trained Goal Performance | Post | 6.83 units on a scale | Standard Deviation 1.2 |
| Attention Control Group | Canadian Occupational Performance Measure (COPM) Trained Goal Performance | Baseline | 4.1 units on a scale | Standard Deviation 1.6 |
| Attention Control Group | Canadian Occupational Performance Measure (COPM) Trained Goal Performance | Post | 5.7 units on a scale | Standard Deviation 1.7 |
95% CI: [-0.16, 1.05]
Primary
Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction
Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Time frame: After study completion, an average of 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction | Baseline | 4.2 units on a scale | Standard Deviation 2.3 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction | Post | 6.9 units on a scale | Standard Deviation 1.5 |
| Attention Control Group | Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction | Baseline | 3.4 units on a scale | Standard Deviation 1.8 |
| Attention Control Group | Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction | Post | 5.4 units on a scale | Standard Deviation 2.3 |
95% CI: [-0.3, 0.93]
Primary
Feasibility of Intervention Measure (FIM)
Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Feasibility of Intervention Measure (FIM) | 4.64 units on a scale | Standard Deviation 0.53 |
| Attention Control Group | Feasibility of Intervention Measure (FIM) | 4.20 units on a scale | Standard Deviation 1.06 |
Primary
Intervention Appropriateness Measure (IAM)
Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Intervention Appropriateness Measure (IAM) | 4.43 units on a scale | Standard Deviation 0.62 |
| Attention Control Group | Intervention Appropriateness Measure (IAM) | 3.83 units on a scale | Standard Deviation 0.9 |
Primary
NeuroQoL Cognitive Function Short Form
Self-report measure of cognitive ability in daily life activity. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). The total raw score range is 8-40. The t-score is reported with a mean of 50 and standard deviation of 10. Higher scores mean fewer perceived cognitive challenges.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | NeuroQoL Cognitive Function Short Form | Baseline | 36.4 units on a scale | Standard Deviation 5.9 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | NeuroQoL Cognitive Function Short Form | Post | 44.0 units on a scale | Standard Deviation 6.8 |
| Attention Control Group | NeuroQoL Cognitive Function Short Form | Baseline | 37.2 units on a scale | Standard Deviation 6.3 |
| Attention Control Group | NeuroQoL Cognitive Function Short Form | Post | 42.6 units on a scale | Standard Deviation 6.3 |
95% CI: [-0.19, 1.03]
Primary
Telehealth Usability Questionnaire (TUQ)
Measure of telehealth usability from participant's perspective. Specifically, the TUQ measures usefulness and utility of technologies including usefulness, ease of use, effectiveness, reliability, and satisfaction. The TUQ uses a self-report Likert scale of 1 (disagree) to 7 (agree).
Time frame: After study completion, an average of 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Telehealth Usability Questionnaire (TUQ) | 6.38 units on a scale | Standard Deviation 0.61 |
| Attention Control Group | Telehealth Usability Questionnaire (TUQ) | 6.31 units on a scale | Standard Deviation 0.61 |
Secondary
Brief Visuospatial Memory Test -Revised Trial 1
Objective measure of episodic memory. Participant is presented with six geometric figures for 10 seconds on three different occasions, and then asked to draw the six figures on a separate sheet of paper in the correct order. Increased errors may indicate challenges with episodic memory. T-scores are reported with a mean of 50 and standard deviation of 10. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Brief Visuospatial Memory Test -Revised Trial 1 | Baseline | 51.0 T-score | Standard Deviation 11.4 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Brief Visuospatial Memory Test -Revised Trial 1 | Post | 47.0 T-score | Standard Deviation 9.4 |
| Attention Control Group | Brief Visuospatial Memory Test -Revised Trial 1 | Baseline | 56.4 T-score | Standard Deviation 12 |
| Attention Control Group | Brief Visuospatial Memory Test -Revised Trial 1 | Post | 54.8 T-score | Standard Deviation 16.2 |
Secondary
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest
Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of Number/Letter switching. Age-adjusted scale scores with a mean of 10 and standard deviation of 3 are reported. The total range of scores is 1-19. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest | Baseline | 10.2 score on a scale | Standard Deviation 2.5 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest | Post | 11.2 score on a scale | Standard Deviation 3.1 |
| Attention Control Group | Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest | Post | 10.3 score on a scale | Standard Deviation 2.6 |
| Attention Control Group | Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest | Baseline | 9.9 score on a scale | Standard Deviation 2.4 |
Secondary
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Self-report measure of quality of life for breast cancer survivors. Domains include questions related to physical, emotional, social, and functional well-being, as well as additional concerns. Minimum = 0 (not at all), Maximum = 4 (very much). The range of scores is 0 to 148. Higher scores indicate decreased perceived well-being and quality of life.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Functional Assessment of Cancer Therapy-Breast (FACT-B) | Baseline | 91.9 units on a scale | Standard Deviation 23.3 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Functional Assessment of Cancer Therapy-Breast (FACT-B) | Post | 99.8 units on a scale | Standard Deviation 21.8 |
| Attention Control Group | Functional Assessment of Cancer Therapy-Breast (FACT-B) | Baseline | 90 units on a scale | Standard Deviation 21.6 |
| Attention Control Group | Functional Assessment of Cancer Therapy-Breast (FACT-B) | Post | 104.3 units on a scale | Standard Deviation 14.3 |
96% CI: [-1.04, 0.21]
Secondary
Paced Auditory Serial Addition Test
Objective measure of working memory. Participant is presented with single digits every 2 seconds and asked to add each digit to the one immediately prior to it. Total score is out of 60 points, with increased errors indicating challenges with working memory.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Paced Auditory Serial Addition Test | Baseline | 26.8 number correct | Standard Deviation 10.2 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Paced Auditory Serial Addition Test | Post | 29.9 number correct | Standard Deviation 10.7 |
| Attention Control Group | Paced Auditory Serial Addition Test | Baseline | 26.2 number correct | Standard Deviation 6.8 |
| Attention Control Group | Paced Auditory Serial Addition Test | Post | 25.7 number correct | Standard Deviation 9.4 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities
Self-report measure of ability to participate in social roles and activities. Higher scores reflect higher abilities. T-scores are reported with a mean of 50 and a standard deviation of 10.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
Population: T-scores are used with mean of 50 and standard deviation of 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities | Baseline | 45.5 T-score | Standard Deviation 8.5 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities | Post | 48.2 T-score | Standard Deviation 9.7 |
| Attention Control Group | Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities | Baseline | 47.1 T-score | Standard Deviation 9.7 |
| Attention Control Group | Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities | Post | 49.7 T-score | Standard Deviation 6.7 |
95% CI: [-0.61, 0.64]
Secondary
Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest
Objective measure of cognitive performance. The Letter-Number subtest measures working memory. The Coding and Symbol Search subtest measure processing speed. Higher scores indicate better cognitive performance. Age adjusted scaled scores with a mean of 10 and standard deviation of 3 are reported. Range of reported scores is 1 to 19.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Letter Number Baseline | 9.4 score on a scale | Standard Deviation 2.4 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Letter Number Post | 10.6 score on a scale | Standard Deviation 3.1 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Symbol Search Baseline | 10.5 score on a scale | Standard Deviation 2.6 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Symbol Search Post | 12.2 score on a scale | Standard Deviation 2.3 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Coding Baseline | 10.6 score on a scale | Standard Deviation 2.6 |
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Coding Post | 9.4 score on a scale | Standard Deviation 2.7 |
| Attention Control Group | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Coding Baseline | 9.8 score on a scale | Standard Deviation 2.6 |
| Attention Control Group | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Letter Number Baseline | 9.6 score on a scale | Standard Deviation 3.6 |
| Attention Control Group | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Symbol Search Post | 11.1 score on a scale | Standard Deviation 3.1 |
| Attention Control Group | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Letter Number Post | 10.1 score on a scale | Standard Deviation 2.3 |
| Attention Control Group | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Coding Post | 9.8 score on a scale | Standard Deviation 2.6 |
| Attention Control Group | Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest | Symbol Search Baseline | 9.2 score on a scale | Standard Deviation 2.3 |