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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group: Cognitive Orientation to daily Occupational Performance (CO-OP) | Experimental | 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. |
|
| Attention Control Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO-OP Procedures | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After study completion, an average of 14 weeks |
| Acceptability of Intervention Measure (AIM) | Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) | After study completion, an average of 14 weeks |
| Intervention Appropriateness Measure (IAM) | Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) | After study completion, an average of 14 weeks |
| Feasibility of Intervention Measure (FIM) | Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) | After study completion, an average of 14 weeks |
| Canadian Occupational Performance Measure (COPM) Trained Goal Performance | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. | Pre-intervention (week 0) and post-intervention (week 14) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna E Boone, PhD, OTR/L | University of Missouri Occupational Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Occupational Therapy Department | Columbia | Missouri | 65203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22658913 | Background | Hutchinson AD, Hosking JR, Kichenadasse G, Mattiske JK, Wilson C. Objective and subjective cognitive impairment following chemotherapy for cancer: a systematic review. Cancer Treat Rev. 2012 Nov;38(7):926-34. doi: 10.1016/j.ctrv.2012.05.002. Epub 2012 Jun 2. | |
| 23483375 | Background | O'Farrell E, MacKenzie J, Collins B. Clearing the air: a review of our current understanding of "chemo fog". Curr Oncol Rep. 2013 Jun;15(3):260-9. doi: 10.1007/s11912-013-0307-7. |
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One participant was enrolled and signed written consent but withdrew during baseline assessment. Therefore, this participant was never randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Row population differs from overall due to attrition. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | After study completion, an average of 14 weeks |
|
Through study completion, up to 14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall in community | Injury, poisoning and procedural complications | Non-systematic Assessment | Pt was walking in the community when she tripped and fell, resulting in R humeral neck fracture. Pt's husband was present and accompanied her to the physician. She received a sling for RUE. Pt's schedule was revised to accommodate all 10 sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Boone, PhD | University of Missouri | 573-882-7023 | booneae@umsystem.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 9, 2023 | Oct 15, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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.
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All outcomes assessors will be blinded to participant study group assignment.
|
| Attention Control Procedures | Behavioral | 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. |
|
| Pre-intervention (week 0) and post-intervention (week 14) |
| 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. | After study completion, an average of 14 weeks |
| Pre-intervention (week 0) and post-intervention (week 14) |
| 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. | Pre-intervention (week 0) and post-intervention (week 14) |
| 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. | Pre-intervention (week 0) and post-intervention (week 14) |
| 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. | Pre-intervention (week 0) and post-intervention (week 14) |
| 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. | Pre-intervention (week 0) and post-intervention (week 14) |
| 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. | Pre-intervention (week 0) and post-intervention (week 14) |
| 19472296 | Background | Reid-Arndt SA, Hsieh C, Perry MC. Neuropsychological functioning and quality of life during the first year after completing chemotherapy for breast cancer. Psychooncology. 2010 May;19(5):535-44. doi: 10.1002/pon.1581. |
| 19813133 | Background | Reid-Arndt SA, Yee A, Perry MC, Hsieh C. Cognitive and psychological factors associated with early posttreatment functional outcomes in breast cancer survivors. J Psychosoc Oncol. 2009;27(4):415-34. doi: 10.1080/07347330903183117. |
| 11128897 | Background | Cicerone KD, Dahlberg C, Kalmar K, Langenbahn DM, Malec JF, Bergquist TF, Felicetti T, Giacino JT, Harley JP, Harrington DE, Herzog J, Kneipp S, Laatsch L, Morse PA. Evidence-based cognitive rehabilitation: recommendations for clinical practice. Arch Phys Med Rehabil. 2000 Dec;81(12):1596-615. doi: 10.1053/apmr.2000.19240. |
| 21440699 | Background | Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015. |
| Background | Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based Recommendations into Practice. Vol 1. Reston, VA: American Congress of Rehabilitation Medicine; 2012. |
| 27449501 | Background | Wolf TJ, Doherty M, Kallogjeri D, Coalson RS, Nicklaus J, Ma CX, Schlaggar BL, Piccirillo J. The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment. Oncology. 2016;91(3):143-52. doi: 10.1159/000447744. Epub 2016 Jul 23. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Row population differs from overall population due to attrition. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Row population differs from overall population due to attrition. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Row population differs from overall population due to attrition. | Count of Participants | Participants |
|
| Region of Enrollment | Row population differs from overall population due to attrition. | Number | participants |
|
| Education | Row population differs from overall population due to attrition. | Mean | Standard Deviation | years |
|
| Breast cancer stage | Row population differs from overall population due to attrition. | Count of Participants | Participants |
|
| Chemotherapy length | Row population differs from overall population due to attrition. | Mean | Standard Deviation | months |
|
| Time post chemotherapy | Row population differs from overall population due to attrition. | Mean | Standard Deviation | months |
|
| Radiation | Received radiation=yes Did not receive radiation=no | Row population differs from the overall population due to attrition. | Count of Participants | Participants |
|
| Hormonal therapies | Received hormonal therapies=yes Did not receive hormonal therapies=no | Row population differs from overall population due to attrition. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Acceptability of Intervention Measure (AIM) | Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) | Posted | Mean | Standard Deviation | units on a scale | After study completion, an average of 14 weeks |
|
|
|
| Primary | Intervention Appropriateness Measure (IAM) | Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) | Posted | Mean | Standard Deviation | units on a scale | After study completion, an average of 14 weeks |
|
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|
| Primary | Feasibility of Intervention Measure (FIM) | Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree) | Posted | Mean | Standard Deviation | units on a scale | After study completion, an average of 14 weeks |
|
|
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| Primary | Canadian Occupational Performance Measure (COPM) Trained Goal Performance | Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance. | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | After study completion, an average of 14 weeks |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | number correct | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
| 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. | T-scores are used with mean of 50 and standard deviation of 10 | Posted | Mean | Standard Deviation | T-score | Pre-intervention (week 0) and post-intervention (week 14) |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 3 |
| 23 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
|
| Fall at home | Injury, poisoning and procedural complications | Non-systematic Assessment | Pt reported that she fell due to tripping 2x at home (same day). She had no injuries besides soreness and no medical attention was required. Pt's husband was present. No disruption to treatment schedule. |
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| Bleeding at incision site | Injury, poisoning and procedural complications | Non-systematic Assessment | Pt had medical procedure on Monday 9/11/23 and on Friday 9/15/23 had bleeding at incision site. Pt went to ER for treatment and rested over the weekend. Pt returned to work on Monday 9/18/23 and did not miss any study sessions as a result. |
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| Symbol Search Baseline |
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| Symbol Search Post |
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| Coding Baseline |
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| Coding Post |
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