Clinical trial NCT00710658: Internet Support for Cancer Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Breast Cancer
Prostate Cancer
Keywords: Internet support
Tailored information
Self-management
Quality of life
Online messaging
Online discussion groups
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Cancer Society
First posted: 2008-07-04
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptom distress
timeFrame: prospective, one year, repeated measures
measure: Quality of life
timeFrame: prospective, one year, repeated measures
measure: Depression
timeFrame: prospective, one year, repeated measures
Secondary outcomes:
measure: Self-efficacy
timeFrame: prospective, one year, repeated measures
measure: Social support
timeFrame: prospective, one year, repeated measures
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet
Study officials:
affiliation: Rikshospitalet-Radiumhospitalet
name: Cornelia M Ruland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruland CM, Andersen T, Jeneson A, Moore S, Grimsbo GH, Borosund 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/NCC.0b013e31824d90d4.
citation: Ruland CM, Maffei RM, Borosund E, Krahn A, Andersen T, Grimsbo 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):593-603. doi: 10.1016/j.ijmedinf.2013.02.007. Epub 2013 Mar 16.
citation: Borosund 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.
citation: Grimsbo 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 2012 Feb 11.
citation: Grimsbo 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.
citation: 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.
citation: Ruland CM, Jeneson A, Andersen T, Andersen R, Slaughter L, Bente-Schjodt-Osmo, Moore SM. Designing tailored Internet support to assist cancer patients in illness management. AMIA Annu Symp Proc. 2007 Oct 11;2007:635-9.