Clinical trial NCT01630681: Internet Based Screening and Stepped Care for Cancer Patients With Anxiety and Depression Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Anxiety
Depression
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in depression
timeFrame: From baseline and 10 months later (after intervention)
measure: Change in anxiety
timeFrame: From baseline and 10 months later (after intervention)
Secondary outcomes:
measure: Change in health related quality of life
timeFrame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
measure: Change in Cancer related fatigue (CRF)
timeFrame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
measure: Change in insomnia
timeFrame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
measure: Change in posttraumatic stress
timeFrame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: The hospital i Gävle
state: Gävleborg
city: Uppsala
country: Sweden
facility: Uppsala university hospital
state: Uppland
city: Västerås
country: Sweden
facility: Västmanlands hospital Västerås
state: Västmanland
Study officials:
affiliation: Uppsala University
name: Louise von Essen, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.