CClinicalTrials.gg
CompletedNCT02157454DIPExRCTUpdated Nov 10, 2015

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

An interventional study of Website access in Colorectal Cancer, sponsored by Berlin School of Public Health. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by Berlin School of Public Health · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's enrollment of 212 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Berlin School of Public Health is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients diagnosed with colorectal cancer more than 3 years ago and without metastases or relapse
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (actual)

Study arms

  • Experimental
    Website access

    Two-week access to the colorectal cancer module of the website www.krankheitserfahrungen.de

    Other: Website access

  • 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.

Interventions

  • OtherWebsite 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

06

What researchers measure

Primary outcomes

  1. Self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)

    Time frame: after 2 weeks

Secondary outcomes

  1. Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)

    Time frame: At baseline and after 2 weeks

  2. Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)

    Time frame: At baseline and after 6 weeks

  3. Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)

    Time frame: After 2 weeks

  4. Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)

    Time frame: After 6 weeks

07

Study locations

1 site
  • Berlin School of Public Health
    Berlin, 13347, Germany
08

References and documents

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. PubMed 29030329 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02157454
Lead sponsor
Berlin School of Public Health
Collaborators
Federal Ministry of Health, Germany
Responsible party
Christine Holmberg (Dr., MPH, Berlin School of Public Health) — Principal investigator
First posted
Jun 6, 2014
Start date
Jun 2014
Primary completion
Sep 2015
Completion
Nov 2015
Last update
Nov 10, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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