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

NCT ID: NCT01630681

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 229 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Internet-based stepped care

Intervention Type: BEHAVIORAL

Interactive support and Cognitive Behavioral Therapy

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-based stepped care

Interactive support and Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Other Intervention Names

Self-help program; Internet-based CBT

Eligibility 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 (< 6 month)
• cognitive disability (e.g. dementia or psychosis)
• severe depression or suicide risk

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise von Essen, Professor

Role: STUDY_DIRECTOR

Uppsala University

Locations

The hospital i Gävle

Gävle, Gävleborg County, Sweden

Uppsala university hospital

Uppsala, Uppland, Sweden

Västmanlands hospital Västerås

Västerås, Västmanland County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 32224483 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24024826 (View on PubMed)

Other Identifiers

U-CARE AdultCan

Identifier Type: -

Identifier Source: org_study_id