Clinical trial NCT02157454: Effect of a Website Offering Individual Patients' Experiences for Cancer Patients
Official title: Randomized Controlled Trial to Evaluate the Effect of a Website Offering Individual Patient's Experiences on Patient Competence of Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Berlin School of Public Health
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Health, Germany
First posted: 2014-06-06
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)
timeFrame: after 2 weeks
Secondary outcomes:
measure: Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)
timeFrame: At baseline and after 2 weeks
measure: Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)
timeFrame: At baseline and after 6 weeks
measure: Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)
timeFrame: After 2 weeks
measure: Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)
timeFrame: After 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Berlin School of Public Health
Study officials:
References:
citation: Giesler JM, Keller B, Repke T, Leonhart R, Weis J, Muckelbauer R, Rieckmann N, Muller-Nordhorn J, Lucius-Hoene G, Holmberg C. Effect of a Website That Presents Patients' Experiences on Self-Efficacy and Patient Competence of Colorectal Cancer Patients: Web-Based Randomized Controlled Trial. J Med Internet Res. 2017 Oct 13;19(10):e334. doi: 10.2196/jmir.7639.