Effect of a Website Offering Individual Patients' Experiences for Cancer Patients (DIPExRCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Website access

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13347
    • Berlin School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Website access; Two-week access to the colorectal cancer module of the website www.krankheitserfahrungen.de	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
No Intervention: Control; Participants who are randomized to the control group don't have access to the website until they have finished the last questionnaire at 6 weeks follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)	after 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)	After 2 weeks
Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)	After 6 weeks

Collaborators and Investigators

• Sponsor: Berlin School of Public Health
• Collaborators: Federal Ministry of Health, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NKP-332-041