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Completed

NCT Number: NCT01630681

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The hospital i Gävle, Gävle, Gävleborg County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based stepped care

Behavioral

Interactive support and Cognitive Behavioral Therapy

Other names: Self-help program, Internet-based CBT

Primary outcomes

  1. Change in depression

    Time frame: From baseline and 10 months later (after intervention)

    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.

  2. Change in anxiety

    Time frame: From baseline and 10 months later (after intervention)

    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 outcomes

  1. Change in health related quality of life

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

    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).

  2. Change in Cancer related fatigue (CRF)

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

    The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)

  3. Change in insomnia

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

    Insomnia Severity Index (ISI)

  4. Change in posttraumatic stress

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

    Posttraumatic Stress Disorder Checklist - Civilian version (PCL-C)

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study 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

Acronym: AdultCan

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2012
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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