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

• ClinicalTrials.gov Identifier: NCT01630681
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: February 16, 2017
• Sponsor: Uppsala University
• Information provided by (Responsible Party): Uppsala University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer; Anxiety; Depression	Behavioral: Internet-based stepped care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 229 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: April 2013
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 (< 6 month)
• cognitive disability (e.g. dementia or psychosis)
• severe depression or suicide risk

Contacts and Locations

Locations

Sweden

The hospital i Gävle

Gävle, Gävleborg, Sweden, 80187

Uppsala university hospital

Uppsala, Uppland, Sweden, 75105

Västmanlands hospital Västerås

Västerås, Västmanland, Sweden, 72189

Sponsors and Collaborators

Uppsala University

Investigators

• Study Director: Louise von Essen, Professor; Uppsala University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hauffman A, Alfonsson S, Igelström 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.

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.

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT01630681
• Other Study ID Numbers: U-CARE AdultCan
• First Posted: June 28, 2012
• Last Update Posted: February 16, 2017
• Last Verified: February 2017

Additional relevant MeSH terms:

Depression; Depressive Disorder; Anxiety Disorders; Behavioral Symptoms; Mood Disorders; Mental Disorders