NCT02157454

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

May 27, 2014

Last Update Submit

November 9, 2015

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

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

    after 2 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

Website access

EXPERIMENTAL

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

Other: Website access

Control

NO INTERVENTION

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

Website accessOTHER

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

Website access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with colorectal cancer within the last 3 years or with metastases or relapse after colorectal cancer
  • having access to internet

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berlin School of Public Health

Berlin, State of Berlin, 13347, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29030329DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., MPH

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 6, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

DE(1)