Web-based Screening and Tailored Support

Breast Cancer Clinical Trial

— ENCOURAGE  

Official title:

Web-based Screening and Tailored Support for Breast Cancer Patients at the Onset of the Survivorship Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834521
• Other study ID #: ENCOURAGE2-2012
• Secondary ID: NL41408.042.12
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ever expanding breast cancer survivor population urges the health care system to develop (cost-)effective screening and management of convalescent care needs that can be easily implemented in conventional follow-up care. Internet-delivered systems may be well-equipped to meet these demands. The aim of the current study is to assess the effectiveness of a web-based support system. Key features of this system are patient self-screening of physical and psychosocial problems, tailored patient education on reported problems and self-referral to professional care. In this era of high internet usage, we expect that internet is a highly suitable medium to provide tailored support for breast cancer patients and will empower the patient to take control over their convalescence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult female breast cancer patients (aged = 18 years of age).

• Recent completion (=6 months) of (neo)adjuvant chemotherapy for primary breast cancer

• Ability to comprehend Dutch (both reading and writing).

• Access to internet (e.g. at home, via family or friends)

• Informed consent provided

Exclusion Criteria:

• Chemotherapy treatment with palliative intent or recurrent breast cancer

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Web-based screening and tailored support

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from 6 to 12 weeks follow-up in optimism and control over the future	Patients' optimism and control over the future will be measured by the subscale 'increased optimism and control over the future' of the 'Constructs Empowering Outcomes Questionnaire'. The subscale 'optimism and control over the future' represents a single concept/outcome measure. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.	6 and 12 weeks
Secondary	Change from 6 to 12 weeks follow-up in knowledge level	Patient knowledge level will be measured by the subscale 'being better informed' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.	6 and 12 weeks
Secondary	Change from 6 weeks to 12 weeks follow-up in acceptance of problems	Patients' acceptance of their problems will be measured by the subscale 'improved acceptance of the illness' of the 'Constructs Empowering Outcomes Questionnaire'. The concept cannot be assessed at baseline due to the retrospective nature of the questionnaire.	6 and 12 weeks
Secondary	Change from baseline to 12 weeks follow-up in quality of life	Cancer-specific quality of life will be measured by the EORTC QLQ-C30 (version 3.0) questionnaire.	Baseline and 12 weeks follow-up
Secondary	Change from baseline to 12 weeks follow-up in psychological distress	Psychological distress will be measured by the Dutch Distress Thermometer and Problem List.	Baseline and 12 weeks follow-up