Effects of Internet Support for Cancer Patients

NCT00971009 | Completed

• 1 other identifier: 2009051
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Symptom management; Interactive Health Communication Application; Patient-provider communication; Health care costs

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (3)

OPPC service

EXPERIMENTAL

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

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.

Behavioral: WebChoice IHCA

Control group

NO INTERVENTION

The control group receives usual care

Interventions

OPPC service BEHAVIORAL

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

OPPC service

WebChoice IHCA 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.

WebChoice IHCA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Excluded are patients who had received radiation on the brain as this may affect their abilities to reliably report their symptoms

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital - Rikshospitalet

Oslo, 0027, Norway

Location

Related Publications (1)

• 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.

  PMID: 25525672 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cornelia M Ruland, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 3, 2009
• Study Start: March 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

NO (1)