An interventional study of CO-OP Procedures and Attention Control Procedures in Breast Cancer Female, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to female participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: CO-OP Procedures
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.
Behavioral: Attention Control 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.
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)
Measure of telehealth usability from participant's perspective. Specifically, the TUQ measures usefulness and utility of technologies including usefulness, ease of use, effectiveness, reliability, and satisfaction. The TUQ uses a self-report Likert scale of 1 (disagree) to 7 (agree).
Time frame: After study completion, an average of 14 weeks
Acceptability of Intervention Measure (AIM)
Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 14 weeks
Intervention Appropriateness Measure (IAM)
Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 14 weeks
Feasibility of Intervention Measure (FIM)
Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
Time frame: After study completion, an average of 14 weeks
Canadian Occupational Performance Measure (COPM) Trained Goal Performance
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
NeuroQoL Cognitive Function Short Form
Self-report measure of cognitive ability in daily life activity. Maximum = 5 (never), Minimum = 1 (Very often/several times per day). The total raw score range is 8-40. The t-score is reported with a mean of 50 and standard deviation of 10. Higher scores mean fewer perceived cognitive challenges.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
Canadian Occupational Performance Measure (COPM) Trained Goal Satisfaction
Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
Time frame: After study completion, an average of 14 weeks
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Self-report measure of quality of life for breast cancer survivors. Domains include questions related to physical, emotional, social, and functional well-being, as well as additional concerns. Minimum = 0 (not at all), Maximum = 4 (very much). The range of scores is 0 to 148. Higher scores indicate decreased perceived well-being and quality of life.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
Delis-Kaplan Executive Function System (DKEFS)- Color-Word Interference Subtest
Objective measure of inhibition and cognitive flexibility. Data are presented for condition 4 of Number/Letter switching. Age-adjusted scale scores with a mean of 10 and standard deviation of 3 are reported. The total range of scores is 1-19. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
Wechsler Adult Intelligence Scale (WAIS)-IV Letter-Number, Coding, Symbol Search Subtest
Objective measure of cognitive performance. The Letter-Number subtest measures working memory. The Coding and Symbol Search subtest measure processing speed. Higher scores indicate better cognitive performance. Age adjusted scaled scores with a mean of 10 and standard deviation of 3 are reported. Range of reported scores is 1 to 19.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
Brief Visuospatial Memory Test -Revised Trial 1
Objective measure of episodic memory. Participant is presented with six geometric figures for 10 seconds on three different occasions, and then asked to draw the six figures on a separate sheet of paper in the correct order. Increased errors may indicate challenges with episodic memory. T-scores are reported with a mean of 50 and standard deviation of 10. Higher scores indicate better performance.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
Paced Auditory Serial Addition Test
Objective measure of working memory. Participant is presented with single digits every 2 seconds and asked to add each digit to the one immediately prior to it. Total score is out of 60 points, with increased errors indicating challenges with working memory.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities
Self-report measure of ability to participate in social roles and activities. Higher scores reflect higher abilities. T-scores are reported with a mean of 50 and a standard deviation of 10.
Time frame: Pre-intervention (week 0) and post-intervention (week 14)
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.
| Milestone | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Started | 23 | 22 |
| Completed | 21 | 21 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
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).
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Telehealth Usability Questionnaire (TUQ) | 6.38 ± 0.61 | 6.31 ± 0.61 |
Measure of intervention acceptability. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | 4.58 ± 0.55 | 4.25 ± 0.58 |
Measure of intervention appropriateness. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Intervention Appropriateness Measure (IAM) | 4.43 ± 0.62 | 3.83 ± 0.90 |
Measure of intervention feasibility. Self-report Likert scale of 1 (completely disagree) to 5 (completely agree)
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Feasibility of Intervention Measure (FIM) | 4.64 ± 0.53 | 4.20 ± 1.06 |
Self-report measure of activity performance. Minimum = 1, Maximum = 10. Higher scores mean better performance.
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 4.4 ± 1.3 | 4.1 ± 1.6 |
| Post | 6.83 ± 1.2 | 5.7 ± 1.7 |
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.
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 36.4 ± 5.9 | 37.2 ± 6.3 |
| Post | 44.0 ± 6.8 | 42.6 ± 6.3 |
Self-report measure of satisfaction level with activity performance. Minimum = 1, Maximum = 10. Higher scores mean higher satisfaction.
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 4.2 ± 2.3 | 3.4 ± 1.8 |
| Post | 6.9 ± 1.5 | 5.4 ± 2.3 |
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.
| units on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 91.9 ± 23.3 | 90 ± 21.6 |
| Post | 99.8 ± 21.8 | 104.3 ± 14.3 |
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.
| score on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 10.2 ± 2.5 | 9.9 ± 2.4 |
| Post | 11.2 ± 3.1 | 10.3 ± 2.6 |
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.
| score on a scale | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Letter Number Baseline | 9.4 ± 2.4 | 9.6 ± 3.6 |
| Letter Number Post | 10.6 ± 3.1 | 10.1 ± 2.3 |
| Symbol Search Baseline | 10.5 ± 2.6 | 9.2 ± 2.3 |
| Symbol Search Post | 12.2 ± 2.3 | 11.1 ± 3.1 |
| Coding Baseline | 10.6 ± 2.6 | 9.8 ± 2.6 |
| Coding Post | 9.4 ± 2.7 | 9.8 ± 2.6 |
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.
| T-score | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 51.0 ± 11.4 | 56.4 ± 12.0 |
| Post | 47.0 ± 9.4 | 54.8 ± 16.2 |
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.
| number correct | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 26.8 ± 10.2 | 26.2 ± 6.8 |
| Post | 29.9 ± 10.7 | 25.7 ± 9.4 |
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-score | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Baseline | 45.5 ± 8.5 | 47.1 ± 9.7 |
| Post | 48.2 ± 9.7 | 49.7 ± 6.7 |
Collected over Through study completion, up to 14 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | 0/23 (0%) | 0/23 (0%) | 3/23 (13%) |
| Attention Control Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Event | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group |
|---|---|---|
| Fall in communityInjury, poisoning and procedural complications | 1/23 | 0/22 |
| Fall at homeInjury, poisoning and procedural complications | 1/23 | 0/22 |
| Bleeding at incision siteInjury, poisoning and procedural complications | 1/23 | 0/22 |
| Age, Continuous(years) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| Mean | 52.8 ± 9.7 | 56.5 ± 10.6 | 53.9 ± 10.0 |
| Sex: Female, Male(Participants) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| Female | 21 | 21 | 42 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 19 | 21 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| White | 20 | 17 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
| Education(years) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| Mean | 15.9 ± 2.4 | 16.0 ± 2.7 | 15.9 ± 2.5 |
| Breast cancer stage(Participants) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| Invasive Ductal Stage 1 | 6 | 8 | 14 |
| Invasive Ductal Stage 2 | 5 | 7 | 12 |
| Invasive Ductal Stage 3 | 6 | 4 | 10 |
| Invasive Lobular Stage 1 | 2 | 0 | 2 |
| Invasive Lobular Stage 2 | 1 | 1 | 2 |
| Invasive Lobular Stage 3 | 1 | 1 | 2 |
| Chemotherapy length(months) | Treatment Group: Cognitive Orientation to Daily Occupational Performance (CO-OP) | Attention Control Group | Total |
|---|---|---|---|
| Mean | 5.9 ± 4.6 | 6.4 ± 4.3 | 6.2 ± 4.4 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Oct 2022 to primary completion in Apr 2024, 17 months.
Results were first posted in Dec 2024, 8 months after primary completion.
Of 1,358 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 71. This study's 17 months is below that.
Counting every sponsor, half of 1,404 studies reached it within 38 months; a quarter within 17 and three quarters within 71.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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