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Kognitivní rehabilitace po léčbě rakoviny prsu

17. září 2026 aktualizováno: Anna Boone, University of Missouri-Columbia

Pilotní testování školení metakognitivní strategie k řešení kognitivních poruch souvisejících s rakovinou u rakoviny prsu

The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.

Přehled studie

Detailní popis

Breast cancer survivors often self-report cognitive deficits, primarily in executive functioning (planning, problem solving, multitasking), memory, and processing speed after cancer treatment, i.e., cancer-related cognitive impairment (CRCI). The prevalence of CRCI following breast cancer is as high as 78% and can persist chronically after treatment has ended. In other health conditions associated with cognitive impairment, such as traumatic brain injury, the only evidence-based recommended practice standard for deficits in executive function is metacognitive strategy training (MCST). In this approach, participants are taught a general cognitive strategy that can be applied in known and novel contexts to devise task specific strategies to successfully engage in an activity. While the cognitive deficits identified in and described by breast cancer survivors seem quite amenable to MCST, there is no study in the published literature which measures the efficacy of MCST on CRCI. 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. Preliminary data suggest that CO-OP may have a positive impact on subjective and objective cognitive performance in breast cancer survivors with CRCI. Further, this study will evaluate the neurophysiological underpinnings associated with treatment changes through the use of neuroimaging methods.

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

20 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • self-reported CRCI (Global Rating of Cognition dysfunction as "Moderately" "Strongly "or "Extremely" AND a Cognitive Failures Questionnaire1 (CFQ) score >30)
  • completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater than 3 years prior to participation
  • able to read, write, and speak English fluently
  • able to provide valid informed consent
  • have a life expectancy of greater than 6 months at time of enrollment
  • on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)

Exclusion Criteria:

  • prior cancer diagnoses of other sites with evidence of active disease within the past year
  • active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment (MoCA)
  • severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)
  • history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)
  • conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)
  • blue-yellow colorblindness
  • pregnancy

The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria will be used to verify appropriate selection of study participants.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Metacognitive strategy training (MCST)

Each MCST session will be follow the procedures of Cognitive Orientation to daily Occupational Performance (CO-OP) intervention. There will be 10, 45-minute, weekly sessions. All sessions will be delivered in-person with a trained occupational therapist.

The MCST group will follow procedures for the Cognitive Orientation to daily Occupational Performance intervention. First, five functional, everyday life goals are identified collaboratively by the participant and interventionist. In the second meeting, the therapist introduces the approach to the subject and teach a 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.

Aktivní komparátor: Inactive Control Group

Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.

Weekly contact will be made via telephone call to (1) maintain study engagement, (2) introduce weekly social contact with researchers, mimicking some of the potential incidental effects of the experimental group, and (3) ascertain what, if any, additional steps participants have taken to reduce cognitive symptoms. The content of each of these meetings will be tracked in intervention notes.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility measures
Časové okno: After study completion, an average of 12 weeks

Recruitment rate, retention rate

After study completion, an average of 12 weeks
Canadian Occupational Performance Measure (COPM) Performance
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

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

Pre-intervention (week 0) and post-intervention (week 12)
Canadian Occupational Performance Measure (COPM) Satisfaction
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

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

Pre-intervention (week 0) and post-intervention (week 12)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cognitive Failures Questionnaire (CFQ)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Self-report measure of lapses in motor function memory and perception. This questionnaire contains 25 items and scores range from 0 to 100. Higher scores = greater perceived impairment.

Pre-intervention (week 0) and post-intervention (week 12)
Dysexecutive Questionnaire (DEX)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Self-report measure of the functional impact of executive dysfunction. It consists of 20 items within four domains: (1) emotional, (2) motivational, (3) behavioral, and (4) cognitive. Each item is rated for frequency using a 5-point Likert scale ranging from 0 (never) to 4 (very often).

Pre-intervention (week 0) and post-intervention (week 12)
Trail Making Test (TMT)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Part A is an attention, visual search, and motor speed task that involves connecting a series of numbers in ascending order. Part B requires alternating between numbers and letters to assess set shifting and executive abilities.

Pre-intervention (week 0) and post-intervention (week 12)
Controlled Oral Word Association (COWA)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Measure of verbal fluency that requires spontaneous word production for a different letter of the alphabet across three different trials.

Pre-intervention (week 0) and post-intervention (week 12)
The Activity Card Sort (ACS)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Self-report measure of participation in various everyday life activities that are in the categories of low demand leisure, high demand leisure, instrumental activities of daily living, and social activity. Cards are sorted according to if the subject is performing each activity as much, less than, or more as compared to before experiencing cancer-related cognitive impairment.

Pre-intervention (week 0) and post-intervention (week 12)
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

A quality-of-life measure across five domains: Physical, social, emotional, functional well-being, and breast-cancer subscale.

Pre-intervention (week 0) and post-intervention (week 12)
Participation Strategies Self Efficacy Scale (PS-SES)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Self-report measure of self-efficacy in using participation strategies. The subject rates confidence across 35 items within six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work and productivity), (5) managing communication, and (6) advocating for resources.

Pre-intervention (week 0) and post-intervention (week 12)
Paced Auditory Serial Addition Test (PASAT)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Measure of working memory and attention in which a series of single digit numbers are presented audibly individuals. The most recent two digits are to be summed prior to the next digit presented. Two commonly used subversions use a 2 second or 3 second inter-stimulus interval.

Pre-intervention (week 0) and post-intervention (week 12)
Hopkins Verbal Learning Test-Revised (HVLT-R)
Časové okno: Pre-intervention (week 0) and post-intervention (week 12)

Measure of verbal learning and memory in which a list of 12 words is to be recalled. Three learning trials with free recall followed by a delayed recall at 20 minutes and a recognition trial.

Pre-intervention (week 0) and post-intervention (week 12)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Anna E Boone, PhD, OTR/L, University of Missouri Occupational Therapy

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

31. října 2024

Primární dokončení (Odhadovaný)

30. června 2027

Dokončení studie (Odhadovaný)

30. června 2027

Termíny zápisu do studia

První předloženo

5. srpna 2024

První předloženo, které splnilo kritéria kontroly kvality

5. srpna 2024

První zveřejněno (Aktuální)

9. srpna 2024

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. září 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2101565
  • 1R21CA286404 (Grant/smlouva NIH USA)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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