Effects of Internet Support for Cancer Patients (WebChoice 2)
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| First Received Date ICMJE | September 1, 2009 | ||||||||
| Last Updated Date | May 22, 2013 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00971009 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Internet Support for Cancer Patients | ||||||||
| Official Title ICMJE | Effects of Internet Support for Cancer Patients on Health Outcomes, Health Care Utilization and Costs: A Randomized Clinical Trial | ||||||||
| Brief Summary | Being diagnosed and treated for cancer is usually associated with severe physical symptoms, impaired functional status, complex emotional, psychosocial and existential issues and substantial worries. Failure to help patients with their problems and worries can unnecessarily delay patients' recovery and rehabilitation, lead to chronic functional impairments, anxiety and depression and prolong patients' needs for health care and social services. The objectives of this interdisciplinary, international research project that includes collaboration with HELFO (The Norwegian Health Economy Administration), are to test and compare, in a randomized, controlled trial (RCT), the effects of (1) a practice-integrated online patient-provider communication (OPPC) service including access to asking questions to HELFO, (2) a multi-component Interactive Health Communication Application (IHCA) called WebChoice, and (3) usual care on: patient outcomes, health care and social services use and costs. Breast cancer patients undergoing treatment at three different hospitals in Norway will be randomized into two experimental and one control groups and will be followed with 5 repeated measures over one year. The proposed study will contribute to innovative methods and technologies that can radically improve patient-provider communication, care quality, and continuity of care. The two interventions tested in this study, the OPPC service with and without additional features of WebChoice, represent new forms of interactions and information sharing between patients and clinicians where patients can get seamless access to communication and information services from where and whenever they need it. This could significantly contribute to reducing unnecessary suffering, less fragmented health care, better efficiency, patient safety, patient satisfaction and have an impact on patients' health services utilization. The investigators' work addresses, therefore, important health policy goals with the potential for considerable societal gains. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 369 | ||||||||
| Estimated Completion Date | February 2015 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00971009 | ||||||||
| Other Study ID Numbers ICMJE | 2009051 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Cornelia Ruland, Oslo University Hospital | ||||||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||||||
| Collaborators ICMJE | South-Eastern Norway Regional Health Authority | ||||||||
| Investigators ICMJE |
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| Information Provided By | Oslo University Hospital | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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