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

NCT01630681 | Completed

• 1 other identifier: U-CARE AdultCan
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cancer; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in health related quality of life

  From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)

• Change in Cancer related fatigue (CRF)

  From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)

• Change in insomnia

  From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)

• Change in posttraumatic stress

  From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)

Study Arms (2)

Internet-based stepped care

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Interventions

Internet-based stepped care BEHAVIORAL

Interactive support and Cognitive Behavioral Therapy

Also known as: Self-help program, Internet-based CBT

Internet-based stepped care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed Breast- Colorectal- or Prostate cancer or recurrent Colorectal cancer within 3 months form diagnoses

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (3)

The hospital i Gävle

Gävle, Gävleborg County, 80187, Sweden

Location

Uppsala university hospital

Uppsala, Uppland, 75105, Sweden

Location

Västmanlands hospital Västerås

Västerås, Västmanland County, 72189, Sweden

Location

Related Publications (2)

• 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.

  PMID: 32224483 DERIVED

• 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.

  PMID: 24024826 DERIVED

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Louise von Essen, Professor

  Uppsala University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 28, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

SE (3)