Effects of Internet Support for Cancer Patients (WebChoice 2)

This study is ongoing, but not recruiting participants.
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: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: OPPC service
Behavioral: WebChoice IHCA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Internet Support for Cancer Patients on Health Outcomes, Health Care Utilization and Costs: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPPC service
A practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors
Behavioral: OPPC service
Access to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors
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.
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.
No Intervention: Control group
The control group receives usual care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971009

Locations
Norway
Oslo University Hospital - Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Cornelia M Ruland, PhD Oslo University Hospital Rikshospitalet
  More Information

No publications provided

Responsible Party: Cornelia Ruland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00971009     History of Changes
Other Study ID Numbers: 2009051
Study First Received: September 1, 2009
Last Updated: December 5, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Symptom management
Interactive Health Communication Application
Patient-provider communication
Health care costs

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014