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Internet Support for Cancer Patients (WebChoice)

Primary Purpose

Cancer, Breast Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
WebChoice
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Internet support, Tailored information, Self-management, Quality of life, Online messaging, Online discussion groups

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rikshospitalet-Radiumhospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Patients had 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 to a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.

The control group receiving usual care

Outcomes

Primary Outcome Measures

Symptom distress
Quality of life
Depression

Secondary Outcome Measures

Self-efficacy
Social support

Full Information

First Posted
July 3, 2008
Last Updated
May 22, 2013
Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT00710658
Brief Title
Internet Support for Cancer Patients
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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: Relationships between primary and secondary outcomes; How patients' symptom distress varies over time; Patients' preferences for participation in decision making about symptom management How patients use WebChoice, such as frequency of use, duration, most used components; How patients' experience WebChoice's usefulness and ease of use; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast Cancer, Prostate Cancer
Keywords
Internet support, Tailored information, Self-management, Quality of life, Online messaging, Online discussion groups

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients had 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 to a communication area where patients could ask questions to a clinical nurse specialist in cancer care and exchange experiences with other cancer patients.
Arm Title
2
Arm Type
No Intervention
Arm Description
The control group receiving usual care
Intervention Type
Behavioral
Intervention Name(s)
WebChoice
Other Intervention Name(s)
Internet support
Intervention Description
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
Primary Outcome Measure Information:
Title
Symptom distress
Time Frame
prospective, one year, repeated measures
Title
Quality of life
Time Frame
prospective, one year, repeated measures
Title
Depression
Time Frame
prospective, one year, repeated measures
Secondary Outcome Measure Information:
Title
Self-efficacy
Time Frame
prospective, one year, repeated measures
Title
Social support
Time Frame
prospective, one year, repeated measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia M Ruland, PhD
Organizational Affiliation
Rikshospitalet-Radiumhospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet-Radiumhospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22495503
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.
Results Reference
result
PubMed Identifier
23507561
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.
Results Reference
result
PubMed Identifier
23454601
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.
Results Reference
result
PubMed Identifier
22326865
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.
Results Reference
result
PubMed Identifier
20921887
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.
Results Reference
result
PubMed Identifier
19592825
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.
Results Reference
result
PubMed Identifier
18693913
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.
Results Reference
result
Links:
URL
http://www.communicaretools.org/?lang=en-US
Description
CommuniCare tools

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