Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer (CaCRT)
Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer: A Single-arm Proof of Concept Study.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Objectives:
The primary objective of this study is to determine the safety, feasibility and acceptability of an 8-week cognitive training intervention in patients treated for cancer. The secondary objective of the study is to estimate the effect size of CRT in improving neurocognitive functioning and quality of life for three different populations of cancer patients.
Research Design:
This is a single-arm proof of concept study with three cancer groups. Patients treated for cancer with persistent cognitive complaints will be recruited from the outpatient clinic of the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven community. We intend to enroll approximately 30 participants, with approximately 10 from each of the following cancer treatment types (1) participants who are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission; (2) participants who are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical condition; (3) participants who are receiving long-term (6 months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy). Patients in this group who received chemotherapy will be eligible if they completed chemotherapy at least 6 months prior to enrolling. There will be an eight-week intervention period and a two-month follow-up assessment.
Methodology:
Participants will participate in a pre-assessment to establish eligibility, baseline cognitive function, and quality of life. This will be followed by participation in a cognitive remediation program (Brain HQ) for eight weeks during which all participants receive up to 16 hours of computerized cognitive training and 16 45-minute Bridging groups where they learn cognitive skills for daily living. The active treatment phase will be followed by an assessment at the conclusion of treatment to evaluate changes in cognitive function and quality of life. Participants will be invited back to participate in a final follow-up assessment 2 months later.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Connecticut
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West Haven, Connecticut, Spojené státy, 06516
- VA Connecticut Healthcare System
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
1.Participants who:
- are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission or;
- are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical conditions or;
- are receiving long-term (6 months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy). Patients in this group who received chemotherapy will be eligible if they completed chemotherapy at least 6 months prior to enrolling.
2. Subjective reports of cognitive decline. 3. Report that they are interested in seeking treatment to address their cognitive concerns.
4. Age 18 or older. 5. Fluency in English and a 6th grade or higher reading level.
Exclusion Criteria:
- Does not meet one of the three participant categories
- Unstable medical condition.
- History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization.
- Current substance abuse disorder.
- History of, or current central nervous system (CNS) malignancies, CNS radiation, intrathecal chemotherapy, or CNS-involved surgery.
- Current IQ estimate less than 80.
- Unable to give written informed consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Cognitive Remediation Therapy
Cognitive Remediation Training is comprised of 8 weeks of active cognitive training using Brain HQ auditory and visual training tasks.
Training is twice per week for up to 2 hours.
Also included is a Bridging Group at each training session.
The Bridging group provides information about cognitive training and compensatory strategies to generalize the benefits of training to daily life.
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Brain HQ is a computer based cognitive training that uses hierarchical adaptive technology to provide challenging and demanding training that is not too frustrating or discouraging.
Training includes auditory and visual sensory training, memory and executive function exercises.
The Bridging group is based on similar training programs that focus on self-regulation training, problem focused cognitive behavior therapy and compensatory cognitive strategies.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Self-report of daily cognitive function
Časové okno: 8 weeks
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Self-reported cognitive function includes symptoms of perceived cognitive impairments, perceived cognitive abilities, and overall quality of life.
These are aggregated into a classification of overall degree of impairment and disability
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8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Neurocognitive function
Časové okno: 8 weeks
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Neurocognitive assessments using neurocognitive tests of attention, processing speed, executive function and memory changes from baseline.
Results are aggregated into an overall score reflecting neurocognitive change from baseline.
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8 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Morris D Bell, Ph.D., Yale University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MIRB 02072 MB0018
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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