Effects of Internet Support for Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: OPPC service
* Behavioral: WebChoice IHCA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPPC service<br>A practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors | Behavioral: OPPC service<br>* Access to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors<br>|
| Experimental: WebChoice IHCA<br>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<br>* 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.<br>|
| No Intervention: Control group<br>The control group receives usual care | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom management, Interactive Health Communication Application, Patient-provider communication, Health care costs