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Kognitiv rehabilitering etter brystkreftbehandling

17. september 2026 oppdatert av: Anna Boone, University of Missouri-Columbia

Pilottesting av metakognitiv strategiopplæring for å adressere kreftrelatert kognitiv svikt i brystkreft

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility measures
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cognitive Failures Questionnaire (CFQ)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. oktober 2024

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

5. august 2024

Først innsendt som oppfylte QC-kriteriene

5. august 2024

Først lagt ut (Faktiske)

9. august 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2101565
  • 1R21CA286404 (U.S. NIH-stipend/kontrakt)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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