Effects of Internet Support for Cancer Patients

NCT ID: NCT00971009

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

OPPC service

A practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors

Group Type: EXPERIMENTAL

OPPC service

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

WebChoice IHCA

Intervention Type: BEHAVIORAL

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.

Control group

The control group receives usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OPPC service

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cornelia Ruland

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cornelia M Ruland, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital - Rikshospitalet

Oslo, , Norway

Countries

Norway

References

Borosund 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 Res. 2014 Dec 18;16(12):e295. doi: 10.2196/jmir.3348.

Reference Type: RESULT

PMID: 25525672 (View on PubMed)

Other Identifiers

2009051

Identifier Type: -

Identifier Source: org_study_id