Internet Support for Cancer Patients

Breast Cancer Clinical Trial

— WebChoice  

Official title:

A Randomized Clincial Trial to Evaluate the Effects of an Internett-based Support System for Cancer Patients on Symptom Distress, Depression, and Quality of Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710658
• Other study ID #: NCS 06067/001
• Status: Completed
• Phase: N/A
• First received: July 3, 2008
• Last updated: May 22, 2013
• Start date: May 2006
• Est. completion date: November 2008

Study information

• Verified date: May 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Cancer patients often experience multiple physical, functional and psychosocial symptoms, but have limited support while being at home between treatments and during rehabilitation. WebChoice is a novel Internet support system that extends traditional health services into patients' homes. The system allows patients to monitor symptoms over time, and provides access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients can ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

This randomized clinical trial:

1. Tests the effects of WebChoice on primary outcomes of symptom distress, quality of life, depression and health service use, and secondary outcomes of self-efficacy, social support . We will also analyze:

2. Relationships between primary and secondary outcomes;

3. How patients' symptom distress varies over time;

4. Patients' preferences for participation in decision making about symptom management

5. How patients use WebChoice, such as frequency of use, duration, most used components;

6. How patients' experience WebChoice's usefulness and ease of use;

7. Patterns and content of patients' communication with the cancer nurse and other patients.

325 cancer patients (189 breast cancer and 136 prostate cancer patients) were recruited from throughout Norway through advertisements and invitation letters and the Norwegian Cancer Registry. Patients were randomly assigned to WebChoice or the control group that received usual care. Patients are being followed with 5 repeated measures over 12 months. Data are being collected through questionnaires, from system logs, and from interviews that were conducted in subset of experimental group patients. The primary hypothesis will be tested with Repeated Measures ANCOVA techniques. The other research questions will be answered using various inferential and descriptive techniques and through content analysis of messages and transcripts of patient interviews. This study can make a significant contribution to reduce unnecessary suffering and improve the quality of life for a large group of cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years

• Starting or currently undergoing treatment for breast or prostate cancer

• Internet access at home

Exclusion Criteria:

• Patients who had received radiation on the brain as this may have affected their abilities to reliably report their symptoms.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Cancer
• Prostate Cancer

Intervention

Behavioral:
• WebChoice
Patients in the experimental group had over the study period access to the Internet support system WebChoice that allowed them to monitor symptoms over time, and provided access to evidence-based self-management options tailored to their reported symptoms as well as a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients. Patients in the control group received usual care

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Cancer Society

Country where clinical trial is conducted

Norway, 

References & Publications (7)

Andersen T, Ruland CM. Cancer patients' questions and concerns expressed in an online nurse-delivered mail service: preliminary results. Stud Health Technol Inform. 2009;146:149-53. — View Citation

Børøsund E, Cvancarova M, Ekstedt M, Moore SM, Ruland CM. How user characteristics affect use patterns in web-based illness management support for patients with breast and prostate cancer. J Med Internet Res. 2013 Mar 1;15(3):e34. doi: 10.2196/jmir.2285. — View Citation

Grimsbø GH, Finset A, Ruland CM. Left hanging in the air: experiences of living with cancer as expressed through E-mail communications with oncology nurses. Cancer Nurs. 2011 Mar-Apr;34(2):107-16. doi: 10.1097/NCC.0b013e3181eff008. — View Citation

Grimsbø GH, Ruland CM, Finset A. Cancer patients' expressions of emotional cues and concerns and oncology nurses' responses, in an online patient-nurse communication service. Patient Educ Couns. 2012 Jul;88(1):36-43. doi: 10.1016/j.pec.2012.01.007. Epub 2 — View Citation

Ruland CM, Andersen T, Jeneson A, Moore S, Grimsbø GH, Børøsund E, Ellison MC. Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial. Cancer Nurs. 2013 Jan-Feb;36(1):6-17. doi: 10.1097/ — View Citation

Ruland CM, Jeneson A, Andersen T, Andersen R, Slaughter L, Bente-Schjødt-Osmo, Moore SM. Designing tailored Internet support to assist cancer patients in illness management. AMIA Annu Symp Proc. 2007 Oct 11:635-9. — View Citation

Ruland CM, Maffei RM, Børøsund E, Krahn A, Andersen T, Grimsbø GH. Evaluation of different features of an eHealth application for personalized illness management support: cancer patients' use and appraisal of usefulness. Int J Med Inform. 2013 Jul;82(7):5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom distress		prospective, one year, repeated measures	No
Primary	Quality of life		prospective, one year, repeated measures	No
Primary	Depression		prospective, one year, repeated measures	No
Secondary	Self-efficacy		prospective, one year, repeated measures	No
Secondary	Social support		prospective, one year, repeated measures	No

External Links

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