Internet Based Screening and Stepped Care for Cancer Patients With Anxiety and Depression Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Uppsala University Psychosocial Care Programme: Internet Based Screening and Stepped Care for Adult Cancer Patients With Anxiety and Depression Symptoms - A Randomized Controlled Trial

Conditions
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Cancer, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Internet-based stepped care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based stepped care<br>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. | Behavioral: Internet-based stepped care<br>* Interactive support and Cognitive Behavioral Therapy<br>* Other names: Internet-based CBT;|
| No Intervention: Standard care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health related quality of life | 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) | 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 | Insomnia Severity Index (ISI) | From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention) | 
| Change in posttraumatic stress | Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C) | From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention) |