Web-based Screening and Tailored Support

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Web-based screening and tailored support

• Registration Number: NCT01834521
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-18
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based screening and tailored support	Web-based screening and tailored support	A personalized website (username/password) will become available to patients assigned to the intervention arm for 12 subsequent weeks. Key features of the website are self-screening, tailored patient education and self-referral. Self-screening will be performed by an online version of the Dutch Distress thermometer (DT) and Problem List (PL). Patients will receive digital feedback on their DT score immediately after test completion together with information regarding problems reported on the PL, (self)help options and possibilities for referral to professional care. Contact information of one of the investigators will also be available to discuss questions, problems and/or referral needs. Patients may also request a telephone call.

Primary Outcome Measures

Name	Time	Method
Change from 6 to 12 weeks follow-up in optimism and control over the future	6 and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline to 12 weeks follow-up in psychological distress	Baseline and 12 weeks follow-up	Psychological distress will be measured by the Dutch Distress Thermometer and Problem List.
Change from 6 to 12 weeks follow-up in knowledge level	6 and 12 weeks	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.
Change from 6 weeks to 12 weeks follow-up in acceptance of problems	6 and 12 weeks	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.
Change from baseline to 12 weeks follow-up in quality of life	Baseline and 12 weeks follow-up	Cancer-specific quality of life will be measured by the EORTC QLQ-C30 (version 3.0) questionnaire.

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands