Web-based Screening and Tailored Support (ENCOURAGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Web-based screening and tailored support

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Web-based screening and tailored support
No Intervention: Standard care; Patients assigned to standard convalescent care will receive the usual follow-up care delivered by their treating oncologists. Patients will be referred to psychosocial or allied care by their oncologist and/or oncology nurse if certain physical and/or psychosocial problems require more in-depth professional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: A.K.L. Reyners, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (Estimated): April 18, 2013

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Breast cancer; psychosocial; empowerment; website
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ENCOURAGE2-2012; NL41408.042.12 (Other Identifier: ABR form Medical Ethical Committee)