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OpenTrials
Completed

NCT Number: NCT01834521

Web-based Screening and Tailored Support

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Empowerment Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Social Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based screening and tailored support

Other

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change from 6 to 12 weeks follow-up in knowledge level

    Time frame: 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.

  2. Change from 6 weeks to 12 weeks follow-up in acceptance of problems

    Time frame: 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.

  3. Change from baseline to 12 weeks follow-up in quality of life

    Time frame: Baseline and 12 weeks follow-up

    Cancer-specific quality of life will be measured by the EORTC QLQ-C30 (version 3.0) questionnaire.

  4. Change from baseline to 12 weeks follow-up in psychological distress

    Time frame: Baseline and 12 weeks follow-up

    Psychological distress will be measured by the Dutch Distress Thermometer and Problem List.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: ENCOURAGE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 18, 2013
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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