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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Website access
Sponsored by
Berlin School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Berlin School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Website access

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)
Change in self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)
Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)
Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)

Full Information

First Posted
May 27, 2014
Last Updated
November 9, 2015
Sponsor
Berlin School of Public Health
Collaborators
Federal Ministry of Health, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02157454
Brief Title
Effect of a Website Offering Individual Patients' Experiences for Cancer Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Berlin School of Public Health
Collaborators
Federal Ministry of Health, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Website access
Arm Type
Experimental
Arm Description
Two-week access to the colorectal cancer module of the website www.krankheitserfahrungen.de
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Website access
Intervention Description
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
Primary Outcome Measure Information:
Title
Self-efficacy for coping with cancer (measured by the German short form of the Cancer Behavior Inventory)
Time Frame
after 2 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)
Time Frame
After 2 weeks
Title
Patient competence (assessed by a self-rating measure of patient competence in oncology in validation process)
Time Frame
After 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Berlin School of Public Health
City
Berlin
ZIP/Postal Code
13347
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
29030329
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.
Results Reference
derived

Learn more about this trial

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

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