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

Depression Clinical Trial

— AdultCan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630681
• Other study ID #: U-CARE AdultCan
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: February 15, 2017
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Internet-based stepped care
Interactive support and Cognitive Behavioral Therapy

Locations

Country	Name	City	State
Sweden	The hospital i Gävle	Gävle	Gävleborg
Sweden	Uppsala university hospital	Uppsala	Uppland
Sweden	Västmanlands hospital Västerås	Västerås	Västmanland

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	Change in insomnia	Insomnia Severity Index (ISI)	From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
Secondary	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)