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Clinical Trials/NCT00710658
NCT00710658
Completed
Not Applicable

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.

Oslo University Hospital1 site in 1 country325 target enrollmentMay 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Oslo University Hospital
Enrollment
325
Locations
1
Primary Endpoint
Symptom distress
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
November 2008
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Cornelia Ruland

Professor

Oslo University Hospital

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.

Outcomes

Primary Outcomes

Symptom distress

Time Frame: prospective, one year, repeated measures

Quality of life

Time Frame: prospective, one year, repeated measures

Depression

Time Frame: prospective, one year, repeated measures

Secondary Outcomes

  • Self-efficacy(prospective, one year, repeated measures)
  • Social support(prospective, one year, repeated measures)

Study Sites (1)

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