Breast CancerWebChoice 2NCT00971009
Effects of Internet Support for Cancer Patients
A study testing OPPC service and WebChoice IHCA in people with Breast Cancer, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- OPPC service and WebChoice IHCA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Excluded are patients who had received radiation on the brain as this may affect their abilities to reliably report their symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- OPPC service, WebChoice IHCA
- Keywords
- Symptom management, Interactive Health Communication Application, Patient-provider communication, Health care costs
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPPC serviceBehavioural
Access to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors
WebChoice IHCABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| OPPC service | Experimental | A practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors Receives: Behavioral: OPPC service |
| WebChoice IHCA | Experimental | 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. Receives: Behavioral: WebChoice IHCA |
| Control group | No intervention | The control group receives usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and duration of symptom distress
Measured: At baseline and at 2, 4, 6, 8 and 12 months
Anxiety and depression
Measured: At baseline an at 2, 4, 6, 8 and 12 months
Secondary outcomes (4)
Self-efficacy
Measured: At baseline and at 2, 4, 6, 8 and 12 months
Uncertainty in illness
Measured: At baseline and at 2, 4, 6, 8 and 12 months
Health care costs
Measured: Post intervention, at 12 and 18 months
Quality of life
Measured: At baseline and at 4, 8 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Cornelia Ruland, Oslo University Hospital
- Investigators
- Cornelia M Ruland, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971009
- Sponsor's protocol ID
- 2009051
- Acronym
- WebChoice 2
- Status last verified
- Oct 2015
- First submitted
- 1 Sep 2009
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25525672
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Internet Support for Cancer Patients on Health Outcomes, Health Care Utilization and Costs: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00971009
- Acronym / sponsor ID
- WebChoice 2 / 2009051
- Conditions
- Breast Cancer
- Keywords
- Symptom management, Interactive Health Communication Application, Patient-provider communication, Health care costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Mar 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OPPC service | Experimental | Behavioral: OPPC serviceA practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors |
| WebChoice IHCA | Experimental | Behavioral: WebChoice IHCAWebChoice 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. |
| Control group | No intervention | –The control group receives usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Excluded are patients who had received radiation on the brain as this may affect their abilities to reliably report their symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPPC serviceAccess to a practice-integrated nurse administered online patient-provider communication (OPPC) service including access to asking questions to social counselors | Behavioural | OPPC service |
| WebChoice IHCAThe 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. | Behavioural | WebChoice IHCA |
Primary outcome
Severity and duration of symptom distress
Time frame: 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
4 secondary outcomes
Self-efficacy
Time frame: 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
Health care costs
Time frame: Post intervention, at 12 and 18 months
Quality of life
Time frame: At baseline and at 4, 8 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Results publication: PubMed 25525672Borosund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelia M Ruland, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPPC service and WebChoice IHCA in people with Breast Cancer, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and duration of symptom distress (time frame: At baseline and at 2, 4, 6, 8 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00971009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.