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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Connecticut
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West Haven、Connecticut、アメリカ、06516
- VA Connecticut Healthcare System
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-report of daily cognitive function
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neurocognitive function
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Morris D Bell, Ph.D.、Yale University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
癌の臨床試験
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Cognitive Remediation Therapyの臨床試験
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University of Texas at Austinまだ募集していません
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Douglas Mental Health University Institute積極的、募集していない
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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Universitätsklinikum Hamburg-Eppendorf完了