Clinical trial NCT00971009: Effects of Internet Support for Cancer Patients
Official title: Effects of Internet Support for Cancer Patients on Health Outcomes, Health Care Utilization and Costs: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Symptom management
Interactive Health Communication Application
Patient-provider communication
Health care costs
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2009-09-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Severity and duration of symptom distress
timeFrame: At baseline and at 2, 4, 6, 8 and 12 months
measure: Anxiety and depression
timeFrame: At baseline an at 2, 4, 6, 8 and 12 months
Secondary outcomes:
measure: Self-efficacy
timeFrame: At baseline and at 2, 4, 6, 8 and 12 months
measure: Uncertainty in illness
timeFrame: At baseline and at 2, 4, 6, 8 and 12 months
measure: Health care costs
timeFrame: Post intervention, at 12 and 18 months
measure: Quality of life
timeFrame: At baseline and at 4, 8 and 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Cornelia M Ruland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.