中枢神経系の原発悪性腫瘍患者の心理的苦痛に関する心理支援看護師の TE テレコンサルテーションの関心 (TECAP)
中枢神経系原発性悪性腫瘍患者の診断発表から最初の治療までの間の精神的苦痛に関する心理支援看護師の TE テレコンサルテーションの関心
The goal of this clinal trial is to compare the effectiveness of nurse-led teleconsultation with usual care (intervention group) on psychological distress in patients with primary malignant tumors of the central nervous system between diagnosis and first anti-cancer treatment, versus usual care alone (control group).
Participants will be randomized into two groups :
- group A) intervention: usual care + nurse teleconsultation for psychological support
- group B) control: usual care alone
Enrolment = Day0 (D0)
Participants will :
- groups A and B: D0: complete 4 questionnaires (Quality of Life, Screening for Distress, Screening for Anxiety and Depression, Social Support Questionnaire)
- Group A : D0+2/4 das : nursing teleconsultation for psychological support
- Groups A and B: D0+10days : telephone call to complete the same 4 questionnaires as at inclusion
- Group A : D0+15days: semi-directive interview, at home, for voluntary patients.
調査の概要
詳細な説明
The expected benefits are as follows:
For the patient :
- Reduction in pre-treatment psychological distress
- Reduced pre-treatment anxiety and depression
- Better understanding of disease and treatments
- Better adherence to the care proposed in the treatment pathway
- Reduced stress during first hospital treatment
For healthcare professionals :
- Early detection of psychological distress
- Early detection of unmet needs and appropriate individualized responses
- Establishment of a climate of trust between patient and caregiver
- Improved professional practices
For the healthcare system :
- Lower healthcare costs (fewer anxiolytic treatments, etc.)
- Therapy to be integrated into the treatment pathway of patients with central nervous system cancer
- Reduced socio-territorial inequalities in healthcare provision
研究の種類
段階
- 適用できない
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:
- aged 18 and over
- being treated for a primary malignant tumor of the central nervous system (positive biopsy)
- with a Mini-Mental State score greater than 24
- not receiving first-line treatment (chemotherapy, targeted radiotherapy, surgery)
- with a distress score above 3 on the Psychological Distress Thermometer
- have access to computer equipment equipped with a microphone and webcam (smartphone, computer)
- able to read, write and speak French
- have given free and informed consent
- being affiliated to a social security scheme
Exclusion Criteria:
- with a history of psychiatric illness
- with recurrent cancer of the cerebral nervous system
- having begun first-line treatment (drug therapy, curative surgery, radiotherapy or palliative care)
- under guardianship, curatorship or deprived of liberty
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：ランダム化
- 介入モデル：並列代入
- 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：TELECONSULTATION
Teleconsultation with a nurse for psychological support, after the diagnosis has been announced, before hospitalization for the first treatment (chemotherapy, surgery, radiotherapy) in addition to the standard practice. |
Teleconsultation with a nurse for psychological support, after the diagnosis has been announced, before hospitalization for the first treatment (chemotherapy, surgery, radiotherapy) in addition to the standard practice |
|
介入なし：NO TELECONSULTATION
The control group will be cared for according to standard practice (without teleconsultation) |
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 |
|---|---|---|
|
Distress thermometer
時間枠：10 days
|
Comparison of the change in psychological distress score, measured using the psychological distress screening tool (from National Comprehensive Cancer Network) between the 2 groups between inclusion (T0) and before the first anti-cancer therapy (T1). |
10 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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。