Internet Support for Cancer Patients

Study 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: 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.

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.

Conditions
-----------------
Cancer, Breast Cancer, Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: WebChoice


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Behavioral: WebChoice<br>* 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<br>* Other names: Internet support;|
| No Intervention: 2<br>The control group receiving usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom distress |  | prospective, one year, repeated measures | 
| Quality of life |  | prospective, one year, repeated measures | 
| Depression |  | prospective, one year, repeated measures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy |  | prospective, one year, repeated measures | 
| Social support |  | prospective, one year, repeated measures | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Internet support, Tailored information, Self-management, Quality of life, Online messaging, Online discussion groups