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临床试验/NCT01834521
NCT01834521已完成不适用

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

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
1
主要终点
Change from 6 to 12 weeks follow-up in optimism and control over the future

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Chemotherapy treatment with palliative intent or recurrent breast cancer

研究组 & 干预措施

Web-based screening and tailored support

Experimental

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.

干预措施: Web-based screening and tailored support (Other)

Standard care

No Intervention

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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