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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Uppsala University
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01630681
First received: May 29, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cancer
Anxiety
Depression
Behavioral: Internet-based stepped care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Change in depression [ Time Frame: From baseline and 10 months later (after intervention) ] [ Designated as safety issue: No ]

    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.


  • Change in anxiety [ Time Frame: From baseline and 10 months later (after intervention) ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Change in health related quality of life [ Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention) ] [ Designated as safety issue: No ]
    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).

  • Change in Cancer related fatigue (CRF) [ Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention) ] [ Designated as safety issue: No ]
    The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)

  • Change in insomnia [ Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention) ] [ Designated as safety issue: No ]
    Insomnia Severity Index (ISI)

  • Change in posttraumatic stress [ Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention) ] [ Designated as safety issue: No ]
    Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C)


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Internet-based stepped care
Interactive support and Cognitive Behavioral Therapy
Other Names:
  • Self-help program
  • Internet-based CBT
No Intervention: Standard care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (< 3 month)
  • cognitive disability (e.g. dementia or psychosis)
  • severe depression or suicide risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630681

Contacts
Contact: Birgitta Johansson, PhD 0046186111070 birgitta.johansson@onkologi.uu.se
Contact: Louise von Essen, Professor 0046184713484 Louise-von.Essen@pubcare.uu.se

Locations
Sweden
The hospital i Gävle Not yet recruiting
Gävle, Gävleborg, Sweden, 80187
Contact: Johan Ahlgren, Ass. prof.    004626154000    johan.ahlgren@lg.se   
Sub-Investigator: Johan Ahlgren, Ass. prof.         
Uppsala university hospital Recruiting
Uppsala, Uppland, Sweden, 75105
Contact: Birgitta Johansson, PhD    0046186111070    birgitta.johansson@onkologi.uu.se   
Sub-Investigator: Birgitta Johansson, PhD         
Västmanlands hospital Västerås Not yet recruiting
Västerås, Västmanland, Sweden, 72189
Contact: Leif Bergkvist, Professor    004621173000    leif.bergkvist@ltv.se   
Sub-Investigator: Leif Bergkvist, Professor         
Sponsors and Collaborators
Uppsala University
Investigators
Study Director: Louise von Essen, Professor Uppsala University
  More Information

No publications provided by Uppsala University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01630681     History of Changes
Other Study ID Numbers: U-CARE AdultCan
Study First Received: May 29, 2012
Last Updated: May 21, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 22, 2014