Internet Based Screening and Stepped Care for Cancer Patients With Anxiety and Depression Symptoms (AdultCan)
Uppsala University Psychosocial Care Programme: Internet Based Screening and Stepped Care for Adult Cancer Patients With Anxiety and Depression Symptoms - A Randomized Controlled Trial
The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and health related quality of life in cancer patients with anxiety and depression symptoms, compared to Standard Care, and to evaluate the health-economic effects of the intervention. The investigators also want to examine the development of anxiety and depression symptoms and health related quality of life in cancer patients without initial symptoms.
The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in relieving anxiety and depression symptoms in cancer patients, compared to Standard Care (SC). Secondary hypotheses are that less anxiety and depression symptoms also means improved health related quality of life and that I SC is cost-effective or at least cost neutral compared to standard care.
The IT-platform Carebase.se is developed within U-CARE. The platform will be used for delivering of interventions and for collection of all patient reported outcomes. Patients with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms will be included in descriptive studies. All patients, in the randomized controlled trial and the descriptive study will followed up during 24 months
I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2). Step 1 starts directly after randomization and extends over a 24 months period. Step one comprises web-based patient education including psycho-education and easy interventions strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and a personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to other experts in the project group for advices about how to answer patients' questions.
Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for common psychological concerns. The participants' chooses to work with modules that correspond to prioritized concerns, e.g. anxiety or depression. The CBT is structured and manualized and include conventional treatment methods with homework and weekly contacts with the psychologist. Step 2 extends over a 10-week period.
調査の概要
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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Gävleborg
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Gävle、Gävleborg、スウェーデン、80187
- The hospital i Gävle
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Uppland
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Uppsala、Uppland、スウェーデン、75105
- Uppsala University Hospital
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Västmanland
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Västerås、Västmanland、スウェーデン、72189
- Västmanlands Hospital Västerås
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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:
- Newly diagnosed Breast- Colorectal- or Prostate cancer or recurrent Colorectal cancer within 3 months form diagnoses
Exclusion Criteria:
- inability to communicate in Swedish
- Karnovsky performance status < 40
- short expected survival (< 6 month)
- cognitive disability (e.g. dementia or psychosis)
- severe depression or suicide risk
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 |
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介入なし：標準ケア
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実験的：Internet-based stepped care
Internet-based stepped care comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2).
Step 1 starts directly after randomization and extends over a 24 months period.
Step 2 extends to a period of ten weeks.
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Interactive support and Cognitive Behavioral Therapy
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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Change in depression
時間枠：From baseline and 10 months later (after intervention)
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Hospital Anxiety and Depression Scale (HADS) - depression subscale. Range 0-21, >7 is defined as doubtful cases and >10 is defined as clinical cases. Montgomery Åsberg Depression Rating Scale (MADRS). Range 0-60 points, >30 is defined as severe depression, >3 at question nr. 9 is defined as suicide risk. |
From baseline and 10 months later (after intervention)
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Change in anxiety
時間枠：From baseline and 10 months later (after intervention)
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Hospital Anxiety and Depression Scale (HADS) - anxiety subscale. Range 0-21, >7 is defined as doubtful cases and >10 is defined as clinical cases. Spielberger State-Trait Anxiety Inventory State subscale (STAI-S). Range 20-80. |
From baseline and 10 months later (after intervention)
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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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Change in health related quality of life
時間枠：From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), the Breast Cancer module (QLQ-BR23), the Colorectal Cancer module (QLQ-CR29) and the Prostate Cancer module (QLQ-PR25).
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From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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Change in Cancer related fatigue (CRF)
時間枠：From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
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From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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Change in insomnia
時間枠：From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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Insomnia Severity Index (ISI)
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From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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Change in posttraumatic stress
時間枠：From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C)
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From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Louise von Essen, Professor、Uppsala University
出版物と役立つリンク
一般刊行物
- Hauffman A, Alfonsson S, Igelstrom H, Johansson B. Experiences of Internet-Based Stepped Care in Individuals With Cancer and Concurrent Symptoms of Anxiety and Depression: Qualitative Exploration Conducted Alongside the U-CARE AdultCan Randomized Controlled Trial. J Med Internet Res. 2020 Mar 30;22(3):e16547. doi: 10.2196/16547.
- Mattsson S, Alfonsson S, Carlsson M, Nygren P, Olsson E, Johansson B. U-CARE: Internet-based stepped care with interactive support and cognitive behavioral therapy for reduction of anxiety and depressive symptoms in cancer--a clinical trial protocol. BMC Cancer. 2013 Sep 11;13:414. doi: 10.1186/1471-2407-13-414.
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 (見積もり)
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。