Breast Cancer Clinical Trial
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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