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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Gävleborg
-
Gävle, Gävleborg, Švédsko, 80187
- The hospital i Gävle
-
-
Uppland
-
Uppsala, Uppland, Švédsko, 75105
- Uppsala University Hospital
-
-
Västmanland
-
Västerås, Västmanland, Švédsko, 72189
- Västmanlands Hospital Västerås
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Standardní péče
|
|
|
Experimentální: 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.
|
Interactive support and Cognitive Behavioral Therapy
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in depression
Časové okno: From baseline and 10 months later (after intervention)
|
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)
|
|
Change in anxiety
Časové okno: From baseline and 10 months later (after intervention)
|
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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in health related quality of life
Časové okno: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
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).
|
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
|
Change in Cancer related fatigue (CRF)
Časové okno: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
|
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
|
Change in insomnia
Časové okno: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
Insomnia Severity Index (ISI)
|
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
|
Change in posttraumatic stress
Časové okno: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C)
|
From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Louise von Essen, Professor, Uppsala University
Publikace a užitečné odkazy
Obecné publikace
- 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.
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 (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- U-CARE AdultCan
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .