Effects of Internet Support for Cancer Patients (WebChoice 2)

This study is currently recruiting participants.
Verified May 2013 by Oslo University Hospital
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Cornelia Ruland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00971009
First received: September 1, 2009
Last updated: May 22, 2013
Last verified: May 2013

September 1, 2009
May 22, 2013
March 2010
August 2014   (final data collection date for primary outcome measure)
  • Severity and duration of symptom distress [ Time Frame: At baseline and at 2, 4, 6, 8 and 12 months ] [ Designated as safety issue: No ]
  • Anxiety and depression [ Time Frame: At baseline an at 2, 4, 6, 8 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00971009 on ClinicalTrials.gov Archive Site
  • Self-efficacy [ Time Frame: At baseline and at 2, 4, 6, 8 and 12 months ] [ Designated as safety issue: No ]
  • Uncertainty in illness [ Time Frame: At baseline and at 2, 4, 6, 8 and 12 months ] [ Designated as safety issue: No ]
  • Health care costs [ Time Frame: Post intervention, at 12 and 18 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: At baseline and at 4, 8 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Internet Support for Cancer Patients
Effects of Internet Support for Cancer Patients on Health Outcomes, Health Care Utilization and Costs: A Randomized Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Breast Cancer
  • Behavioral: OPPC service
    Access to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors
  • Behavioral: WebChoice IHCA
    The additional features of WebChoice allows patients to monitor their symptoms and health problems from home; provides them with individually tailored, just-in-time information and support to manage their symptoms and illness-related problems between treatments and during rehabilitation; and a forum, or e-group community, for group discussion with other cancer patients.
  • Experimental: OPPC service
    A practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors
    Intervention: Behavioral: OPPC service
  • Experimental: WebChoice IHCA
    WebChoice is an interactive health communications application (IHCA) that in addition to offer a practice-integrated nurse administered online patient-provider communication (OPPC) service, allows patients to monitor their symptoms and health problems from home; provides them with individually tailored, just-in-time information and support to manage their symptoms and illness-related problems between treatments and during rehabilitation; and a forum, or e-group community, for group discussion with other cancer patients.
    Intervention: Behavioral: WebChoice IHCA
  • No Intervention: Control group
    The control group receives usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
369
February 2015
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients recently diagnosed with breast cancer and under treatment (radiation, chemotherapy, hormone, or combinations of those)
  • Patients are > 18 years of age, able to write / read / speak Norwegian and have Internet with secure access (BankID) at home

Exclusion Criteria:

  • Excluded are patients who had received radiation on the brain as this may affect their abilities to reliably report their symptoms
Female
18 Years and older
No
Contact: Cornelia M Ruland, PhD 0047-23075460 cornelia.ruland@rr-research.no
Contact: Elin Børøsund, MS elin.borosund@rr-research.no
Norway
 
NCT00971009
2009051
No
Cornelia Ruland, Oslo University Hospital
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Principal Investigator: Cornelia M Ruland, PhD Oslo University Hospital - Rikshospitalet
Oslo University Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP