Web-based Screening and Tailored Support

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Web-based screening and tailored support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based screening and tailored support<br>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<br> <br> |
| No Intervention: Standard care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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website, Breast cancer, psychosocial, empowerment