Effects of Internet Support for Cancer Patients

Breast Cancer Clinical Trial

— WebChoice 2  

Official title:

Effects of Internet Support for Cancer Patients on Health Outcomes, Health Care Utilization and Costs: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971009
• Other study ID #: 2009051
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: October 19, 2015
• Start date: March 2010
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• OPPC service
Access to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors
• 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital - Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Børøsund E, Cvancarova M, Moore SM, Ekstedt M, Ruland CM. Comparing effects in regular practice of e-communication and Web-based self-management support among breast cancer patients: preliminary results from a randomized controlled trial. J Med Internet R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity and duration of symptom distress		At baseline and at 2, 4, 6, 8 and 12 months	No
Primary	Anxiety and depression		At baseline an at 2, 4, 6, 8 and 12 months	No
Secondary	Self-efficacy		At baseline and at 2, 4, 6, 8 and 12 months	No
Secondary	Uncertainty in illness		At baseline and at 2, 4, 6, 8 and 12 months	No
Secondary	Health care costs		Post intervention, at 12 and 18 months	No
Secondary	Quality of life		At baseline and at 4, 8 and 12 months	No