Effects of Internet Support for Cancer Patients (WebChoice 2)

October 19, 2015 updated by: Cornelia Ruland, Oslo University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Oslo University Hospital - Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity and duration of symptom distress
Time Frame: At baseline and at 2, 4, 6, 8 and 12 months
At baseline and at 2, 4, 6, 8 and 12 months
Anxiety and depression
Time Frame: At baseline an at 2, 4, 6, 8 and 12 months
At baseline an at 2, 4, 6, 8 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self-efficacy
Time Frame: At baseline and at 2, 4, 6, 8 and 12 months
At baseline and at 2, 4, 6, 8 and 12 months
Uncertainty in illness
Time Frame: At baseline and at 2, 4, 6, 8 and 12 months
At baseline and at 2, 4, 6, 8 and 12 months
Health care costs
Time Frame: Post intervention, at 12 and 18 months
Post intervention, at 12 and 18 months
Quality of life
Time Frame: At baseline and at 4, 8 and 12 months
At baseline and at 4, 8 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

Investigators

  • Principal Investigator: Cornelia M Ruland, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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