Cancer Related Cognitive Impairment (APACO)
Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
調査の概要
詳細な説明
Inclusion procedure and saving selection failures Participation in this study will be offered to patients during their care in day hospital (= inclusion visit).
Any patient giving express consent to participation and meeting the criteria for inclusion and non-inclusion will then be included in the study.
Each patient will then be identified by his or her initials as a patient number in the study, directly on the basis of collecting the data from the study.
- Study progress for patients Data collection takes place over two different periods. Each period lasts 12 weeks. The Adapted Physical Activity (APA) program is 8 weeks old.
The first period will run from mid-January to early April (first cohort) to collect data from the first patients in the experimental group.
The second period will be from mid-February to the end of April. During this one, it will be necessary to collect the data of the last patients of the experimental group (second cohort) The first two weeks of each period (weeks 1 and 2, weeks 4 and 5) are dedicated to recruiting patients.
During the pre-test session, carried out week 3 for the first cohort and weeks 6 for the second, the patients will carry out different tests and questionnaires: General Information Questionnaires, Education, MoCA (Montreal Cognitive Assessment), GPAQ (Global Physical Activity Questionnaire), Stroop test, test of MEM3 (Echelle Clinique de Mémoire), letter comparison test, HADS (Hospital and Anxiety Depression Scale), and the MFI (Multidimensional Fatigue Inventory). Patients should also wear an actimeter for one week from the day of recruitment.
Patients then take part in a program of Adapted Physical Activity lasting 8 weeks, with 2 sessions per week. The sessions of this program are similar to the APA sessions already offered by sports therapy practitioners. This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing-based exercises.
In the post-test session, which was conducted week 12 for the first cohort and week 15 for the second, some questionnaires and tests are again administered: GPAQ, Stroop test, MEM3 test, letter comparison test, HADS and the MFI. Patients should also wear an actimeter the week before the day of the post-test.
The forecast schedule may be slightly modified depending on unforeseen circumstances and constraints that may occur.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Saint-Herblain、フランス、44800
- 募集
- Institut de Cancérologie de l'Ouest
-
コンタクト：
- BOIFFARD Florence, MD
- 電話番号：+33240679900
- メール：florence.boiffard@ico.unicancer.fr
-
-
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:
- Male or female> or = 18 years old
- Any patient being treated for a cancerous condition and managed by adjuvant chemotherapy.
- Any type of cancer
- Beneficiary of a social protection scheme
- Having as mother tongue the French language
- Patient information and obtaining express consent
Exclusion Criteria:
- Protected subjects known as vulnerable (major under legal protection, adults unable to express their consent, subject admitted to a health and social institution).
- Minor subjects
- Pregnant women, likely to be pregnant or breastfeeding
- Subjects with sensory disabilities affecting vision or hearing
- Neurological or psychiatric antecedents
- Persons deprived of liberty or guardianship (including trusteeship).
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：支持療法
- 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 |
|---|---|
|
実験的：Adapted Physical Activity Program
Patients in the experimental group take part in a program of Adapted Physical Activity lasting 6 weeks, with 2 sessions per week.
|
The sessions in this program are similar to the adapted physical activity sessions already offered by sports therapy practitioners.
This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing exercises.
|
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 |
|---|---|---|
|
Effect of an APA program on cognitive functions (inhibition)
時間枠：8 weeks
|
For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
|
8 weeks
|
|
Effect of an APA program on cognitive functions (speed function of information processing)
時間枠：8 weeks
|
For speed function of information processing, effect of APA program on cognitive functions is evaluated with XO letters comparison test.
During the XO letters comparison test, the participants will have to check the maximum number of identical or different boxes according to the combination of the two letters presented (XO, OX, XX or OO) in 30 seconds.
|
8 weeks
|
|
Effect of an APA program on cognitive functions (Episodic Memory Function)
時間枠：8 weeks
|
For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
時間枠：8 weeks
|
Evaluated with Global Physical Activity Questionnaire
|
8 weeks
|
|
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
時間枠：8 weeks
|
Evaluated with Actimeter
|
8 weeks
|
|
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
時間枠：8 weeks
|
Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)
|
8 weeks
|
|
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
時間枠：8 weeks
|
Level of education: questionnaire measuring the number of years of study
|
8 weeks
|
|
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
時間枠：8 weeks
|
Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).
|
8 weeks
|
|
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
時間枠：8 weeks
|
Fatigue level: Multidimensional Fatigue Inventor (MFI)
|
8 weeks
|
協力者と研究者
捜査官
- 主任研究者：BOIFFARD Florence, MD、Institut de Cancérologie de l'Ouest
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
本研究に関する用語
その他の研究ID番号
- ICO-N-2018-21
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。