Trial Outcomes & Findings for Metacognitive Strategy Training in Cancer-related Cognitive Impairment (NCT NCT05505045)

Last Updated: 2024-12-16

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

46 participants

Primary outcome timeframe

After study completion, an average of 14 weeks

Results posted on

2024-12-16

Participant Flow

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.

One participant was enrolled and signed written consent but withdrew during baseline assessment. Therefore, this participant was never randomized.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	23	22
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Row population differs from overall due to attrition.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: After study completion, an average of 14 weeks

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Telehealth Usability Questionnaire (TUQ)	6.38 units on a scale Standard Deviation 0.61	6.31 units on a scale Standard Deviation 0.61

PRIMARY outcome

Timeframe: After study completion, an average of 14 weeks

Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Acceptability of Intervention Measure (AIM)	4.58 units on a scale Standard Deviation 0.55	4.25 units on a scale Standard Deviation 0.58

PRIMARY outcome

Timeframe: After study completion, an average of 14 weeks

Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Intervention Appropriateness Measure (IAM)	4.43 units on a scale Standard Deviation 0.62	3.83 units on a scale Standard Deviation 0.90

PRIMARY outcome

Timeframe: After study completion, an average of 14 weeks

Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Feasibility of Intervention Measure (FIM)	4.64 units on a scale Standard Deviation 0.53	4.20 units on a scale Standard Deviation 1.06

PRIMARY outcome

Timeframe: Pre-intervention (week 0) and post-intervention (week 14)

Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Canadian Occupational Performance Measure (COPM) Trained Goal Performance Baseline	4.4 units on a scale Standard Deviation 1.3	4.1 units on a scale Standard Deviation 1.6
Canadian Occupational Performance Measure (COPM) Trained Goal Performance Post	6.83 units on a scale Standard Deviation 1.2	5.7 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
NeuroQoL Cognitive Function Short Form Baseline	36.4 units on a scale Standard Deviation 5.9	37.2 units on a scale Standard Deviation 6.3
NeuroQoL Cognitive Function Short Form Post	44.0 units on a scale Standard Deviation 6.8	42.6 units on a scale Standard Deviation 6.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction Baseline	4.2 units on a scale Standard Deviation 2.3	3.4 units on a scale Standard Deviation 1.8
Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction Post	6.9 units on a scale Standard Deviation 1.5	5.4 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Functional Assessment of Cancer Therapy-Breast (FACT-B) Baseline	91.9 units on a scale Standard Deviation 23.3	90 units on a scale Standard Deviation 21.6
Functional Assessment of Cancer Therapy-Breast (FACT-B) Post	99.8 units on a scale Standard Deviation 21.8	104.3 units on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest Baseline	10.2 score on a scale Standard Deviation 2.5	9.9 score on a scale Standard Deviation 2.4
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest Post	11.2 score on a scale Standard Deviation 3.1	10.3 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
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	9.6 score on a scale Standard Deviation 3.6
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	10.1 score on a scale Standard Deviation 2.3
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	9.2 score on a scale Standard Deviation 2.3
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	11.1 score on a scale Standard Deviation 3.1
Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest Coding Baseline	10.6 score on a scale Standard Deviation 2.6	9.8 score on a scale Standard Deviation 2.6
Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest Coding Post	9.4 score on a scale Standard Deviation 2.7	9.8 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Brief Visuospatial Memory Test -Revised Trial 1 Baseline	51.0 T-score Standard Deviation 11.4	56.4 T-score Standard Deviation 12.0
Brief Visuospatial Memory Test -Revised Trial 1 Post	47.0 T-score Standard Deviation 9.4	54.8 T-score Standard Deviation 16.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Paced Auditory Serial Addition Test Baseline	26.8 number correct Standard Deviation 10.2	26.2 number correct Standard Deviation 6.8
Paced Auditory Serial Addition Test Post	29.9 number correct Standard Deviation 10.7	25.7 number correct Standard Deviation 9.4

SECONDARY outcome

Timeframe: Pre-intervention (week 0) and post-intervention (week 14)

Population: T-scores are used with mean of 50 and standard deviation of 10

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.

Outcome measures

Outcome measures
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Baseline	45.5 T-score Standard Deviation 8.5	47.1 T-score Standard Deviation 9.7
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Post	48.2 T-score Standard Deviation 9.7	49.7 T-score Standard Deviation 6.7

Adverse Events

Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Attention Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=23 participants at risk 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.	Attention Control Group n=22 participants at risk 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.
Injury, poisoning and procedural complications Fall in community	4.3% 1/23 • Number of events 1 • Through study completion, up to 14 weeks	0.00% 0/22 • Through study completion, up to 14 weeks
Injury, poisoning and procedural complications Fall at home	4.3% 1/23 • Number of events 2 • Through study completion, up to 14 weeks	0.00% 0/22 • Through study completion, up to 14 weeks
Injury, poisoning and procedural complications Bleeding at incision site	4.3% 1/23 • Number of events 1 • Through study completion, up to 14 weeks	0.00% 0/22 • Through study completion, up to 14 weeks

Additional Information

Anna Boone, PhD

University of Missouri

Phone: 573-882-7023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) n=21 Participants 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.	Attention Control Group n=21 Participants 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.	Total n=42 Participants Total of all reporting groups
Age, Continuous	52.8 years STANDARD_DEVIATION 9.7 • n=5 Participants • Row population differs from overall due to attrition.	56.5 years STANDARD_DEVIATION 10.6 • n=7 Participants • Row population differs from overall due to attrition.	53.9 years STANDARD_DEVIATION 10.0 • n=5 Participants • Row population differs from overall due to attrition.
Sex: Female, Male Female	21 Participants n=5 Participants • Row population differs from overall population due to attrition.	21 Participants n=7 Participants • Row population differs from overall population due to attrition.	42 Participants n=5 Participants • Row population differs from overall population due to attrition.
Sex: Female, Male Male	0 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	0 Participants n=5 Participants • Row population differs from overall population due to attrition.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	2 Participants n=5 Participants • Row population differs from overall population due to attrition.
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants • Row population differs from overall population due to attrition.	21 Participants n=7 Participants • Row population differs from overall population due to attrition.	40 Participants n=5 Participants • Row population differs from overall population due to attrition.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	0 Participants n=5 Participants • Row population differs from overall population due to attrition.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	0 Participants n=5 Participants • Row population differs from overall population due to attrition.
Race (NIH/OMB) Asian	1 Participants n=5 Participants • Row population differs from overall population due to attrition.	1 Participants n=7 Participants • Row population differs from overall population due to attrition.	2 Participants n=5 Participants • Row population differs from overall population due to attrition.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	0 Participants n=5 Participants • Row population differs from overall population due to attrition.
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • Row population differs from overall population due to attrition.	3 Participants n=7 Participants • Row population differs from overall population due to attrition.	3 Participants n=5 Participants • Row population differs from overall population due to attrition.
Race (NIH/OMB) White	20 Participants n=5 Participants • Row population differs from overall population due to attrition.	17 Participants n=7 Participants • Row population differs from overall population due to attrition.	37 Participants n=5 Participants • Row population differs from overall population due to attrition.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	0 Participants n=5 Participants • Row population differs from overall population due to attrition.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	0 Participants n=5 Participants • Row population differs from overall population due to attrition.
Region of Enrollment United States	21 participants n=5 Participants • Row population differs from overall population due to attrition.	21 participants n=7 Participants • Row population differs from overall population due to attrition.	42 participants n=5 Participants • Row population differs from overall population due to attrition.
Education	15.9 years STANDARD_DEVIATION 2.4 • n=5 Participants • Row population differs from overall population due to attrition.	16.0 years STANDARD_DEVIATION 2.7 • n=7 Participants • Row population differs from overall population due to attrition.	15.9 years STANDARD_DEVIATION 2.5 • n=5 Participants • Row population differs from overall population due to attrition.
Breast cancer stage Invasive Ductal Stage 1	6 Participants n=5 Participants • Row population differs from overall population due to attrition.	8 Participants n=7 Participants • Row population differs from overall population due to attrition.	14 Participants n=5 Participants • Row population differs from overall population due to attrition.
Breast cancer stage Invasive Ductal Stage 2	5 Participants n=5 Participants • Row population differs from overall population due to attrition.	7 Participants n=7 Participants • Row population differs from overall population due to attrition.	12 Participants n=5 Participants • Row population differs from overall population due to attrition.
Breast cancer stage Invasive Ductal Stage 3	6 Participants n=5 Participants • Row population differs from overall population due to attrition.	4 Participants n=7 Participants • Row population differs from overall population due to attrition.	10 Participants n=5 Participants • Row population differs from overall population due to attrition.
Breast cancer stage Invasive Lobular Stage 1	2 Participants n=5 Participants • Row population differs from overall population due to attrition.	0 Participants n=7 Participants • Row population differs from overall population due to attrition.	2 Participants n=5 Participants • Row population differs from overall population due to attrition.
Breast cancer stage Invasive Lobular Stage 2	1 Participants n=5 Participants • Row population differs from overall population due to attrition.	1 Participants n=7 Participants • Row population differs from overall population due to attrition.	2 Participants n=5 Participants • Row population differs from overall population due to attrition.
Breast cancer stage Invasive Lobular Stage 3	1 Participants n=5 Participants • Row population differs from overall population due to attrition.	1 Participants n=7 Participants • Row population differs from overall population due to attrition.	2 Participants n=5 Participants • Row population differs from overall population due to attrition.
Chemotherapy length	5.9 months STANDARD_DEVIATION 4.6 • n=5 Participants • Row population differs from overall population due to attrition.	6.4 months STANDARD_DEVIATION 4.3 • n=7 Participants • Row population differs from overall population due to attrition.	6.2 months STANDARD_DEVIATION 4.4 • n=5 Participants • Row population differs from overall population due to attrition.
Time post chemotherapy	19.6 months STANDARD_DEVIATION 8.9 • n=5 Participants • Row population differs from overall population due to attrition.	22.9 months STANDARD_DEVIATION 9.8 • n=7 Participants • Row population differs from overall population due to attrition.	21.2 months STANDARD_DEVIATION 9.4 • n=5 Participants • Row population differs from overall population due to attrition.
Radiation Yes	11 Participants n=5 Participants • Row population differs from the overall population due to attrition.	13 Participants n=7 Participants • Row population differs from the overall population due to attrition.	24 Participants n=5 Participants • Row population differs from the overall population due to attrition.
Radiation No	10 Participants n=5 Participants • Row population differs from the overall population due to attrition.	8 Participants n=7 Participants • Row population differs from the overall population due to attrition.	18 Participants n=5 Participants • Row population differs from the overall population due to attrition.
Hormonal therapies Yes	15 Participants n=5 Participants • Row population differs from overall population due to attrition.	15 Participants n=7 Participants • Row population differs from overall population due to attrition.	30 Participants n=5 Participants • Row population differs from overall population due to attrition.
Hormonal therapies No	6 Participants n=5 Participants • Row population differs from overall population due to attrition.	6 Participants n=7 Participants • Row population differs from overall population due to attrition.	12 Participants n=5 Participants • Row population differs from overall population due to attrition.