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Clinical Trials/NCT01834521
NCT01834521CompletedNot Applicable

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

University Medical Center Groningen2 sites in 1 country128 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
128
Locations
2
Primary Endpoint
Change from 6 to 12 weeks follow-up in optimism and control over the future

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Change from baseline to 12 weeks follow-up in psychological distress(Baseline and 12 weeks follow-up)
  • Change from 6 to 12 weeks follow-up in knowledge level(6 and 12 weeks)
  • Change from 6 weeks to 12 weeks follow-up in acceptance of problems(6 and 12 weeks)
  • Change from baseline to 12 weeks follow-up in quality of life(Baseline and 12 weeks follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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