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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01630681 |
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Date of registration:
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29/05/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Internet Based Screening and Stepped Care for Cancer Patients With Anxiety and Depression Symptoms
AdultCan |
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Scientific title:
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Uppsala University Psychosocial Care Programme: Internet Based Screening and Stepped Care for Adult Cancer Patients With Anxiety and Depression Symptoms - A Randomized Controlled Trial |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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229 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01630681 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Louise von Essen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Depression
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Anxiety
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Cancer
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Intervention(s)
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Behavioral: Internet-based stepped care
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Primary Outcome(s)
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Change in depression
[Time Frame: From baseline and 10 months later (after intervention)]
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Change in anxiety
[Time Frame: From baseline and 10 months later (after intervention)]
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Secondary Outcome(s)
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Change in Cancer related fatigue (CRF)
[Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)]
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Change in posttraumatic stress
[Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)]
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Change in health related quality of life
[Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)]
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Change in insomnia
[Time Frame: From baseline and, 1, 4, 7, 10, 18 and 24 months later (after intervention)]
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Secondary ID(s)
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U-CARE AdultCan
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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