Effect of a Website Offering Individual Patients' Experiences for Cancer Patients

Colorectal Cancer Clinical Trial

— DIPExRCT  

Official title:

Randomized Controlled Trial to Evaluate the Effect of a Website Offering Individual Patient's Experiences on Patient Competence of Colorectal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157454
• Other study ID #: NKP-332-041
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: November 9, 2015
• Start date: June 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Berlin School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Being diagnosed with cancer confronts patients with a severe disease and they need to learn to deal with a range of new challenges. In order to support patients in the coping process, the website www.krankheitserfahrungen.de provides patients free, reliable information about health issues by sharing peoples' real-life experiences. In our project, the investigators developed a new module on the website for patients with colorectal cancer.

The objective of our study is to evaluate if access to the new colorectal cancer module on the website www.krankheitserfahrungen.de increases patient's competence.

The investigators will conduct a two-arm randomized controlled trial. Patients affected by colorectal cancer will be randomized into an intervention and a control group: the intervention group will have access for two weeks to the website www.krankheitserfahrungen.de (colorectal cancer module) with cancer patients´ experiences. Patients in the control group will not receive any intervention but will have access to the website for two weeks after completing the study.

Patient competence is measured by the self-efficacy component of the German short form of the Cancer Behavior Inventory via an online questionnaire at baseline and after two weeks. A second follow-up assessment will be implemented six weeks after baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with colorectal cancer within the last 3 years or with metastases or relapse after colorectal cancer

• having access to internet

Exclusion Criteria:

• Patients diagnosed with colorectal cancer more than 3 years ago and without metastases or relapse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Website access
Access to the colorectal cancer module of the website www.krankheitserfahrungen.de which provides free, reliable information about health issues by sharing people's real-life experiences

Locations

Country	Name	City	State
Germany	Berlin School of Public Health	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Berlin School of Public Health	Federal Ministry of Health, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)		after 2 weeks	No
Secondary	Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)		At baseline and after 2 weeks	No
Secondary	Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)		At baseline and after 6 weeks	No
Secondary	Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)		After 2 weeks	No
Secondary	Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)		After 6 weeks	No