A Guided Internet Intervention for Women Treated for Gynecological Cancer (GYNEA)
2021年8月24日 更新者：Haukeland University Hospital
Gynecological cancers are the sixth most common cancer forms and the number of survivors is increasing as a consequence of more efficient treatment and longer life span.
As part of regulary care after cancer treatment the women have five years of follow-up with the primary focus on recurrence, aiming to increase survival.
However, several studies have shown that there is no evidence for this assumption on increased survival (ref).
There are now suggested alternative perspectives in the follow up period targeting late effects, health-related quality of life (QoL) and patient satisfaction with care.The main aim of the current study is to test the feasibility and acceptability of an internet-based psychosocial intervention for women treated with curative intent gynecological cancer.
Another aim is to test the perceived effect on gynecological cancer survivors health-related self-care and QoL.
研究概览
详细说明
The study's objectives and research questions Research questions
How did the participants use the program?
- What are the barriers and facilitators concerning technologies of the internet-based self -management intervention?
- Number of logins
- How much time did the participants spend on the program (per login )
- Number of modules completed, number of home-work and mindfulness assignment completed
- Type of errors made …
- What is the participants' perceived credibility of the program?
How do the participants experience the guided psychosocial digital intervention?
- How do participants experience the cancer trajectory, their every-day lives and health-related QoL post-treatment gynaecological cancer (before the intervention)?
- How do the participants experience the internet-based intervention regarding content, the home-work assignments, and the mindfulness assignments, the active participation?
- How do the participants experience the telephone-contact and follow-ups with the nurse once a week?
- Which factors do they describe as important for their satisfaction and dissatisfaction
- How is the perceived effect on the gynecological cancer survivors' competence, QoL, self-care and coping?
It is hypothesized that an internet-based psycho-social intervention will support women in developing self-competence and self-care which could be measured as increased QOL and secondarily affect the impact of cancer, distress, anxiety, depression, self-esteem, and self-reported ability to monitor and respond to symptoms of recurrence.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Tine Nordgreen, PhD
- 电话号码：+4790094913
- 邮箱：tine.nordgreen@gmail.com
研究联系人备份
- 姓名：Ragnhild Sekse
学习地点
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Bergen、挪威、5020
- 招聘中
- Haukeland University Hospital
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接触：
- Tine Nordgreen, PhD
- 电话号码：90094913
- 邮箱：tine.nordgreen@helse-bergen.no
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Vestland
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Bergen、Vestland、挪威、5003
- 招聘中
- Bergen Municipality Division School
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接触：
- Britt Darlington, Advisor
- 电话号码：53033443
- 邮箱：britt.darlington@bergen.kommune.no
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria
- have had gyneocological cancer
- maximum 1 year after gynecological cancer
Exclusion Criteria:
- severe medical or psychiatric condition
- relapse of gynecological cancer
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：GYNEA- digital coping program
Participants randomized to this arm will receive active treatment after the inclusion
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6 modules with relevant information and tools for coping after cancer
其他名称：
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无干预：Waiting list
6 weeks waiting list before crossing over to GYNEA- digital coping program
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Impact of Cancer version 2
大体时间：up to 26 weeks
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Designed to assess the physical and psychosocial health experience of cancer survivors through its positive and negative impacts.
47-item questionnaire organized into 4 positive (altruism and empathy (AE), health awareness (HA), meaning of cancer (MOC), positive self-evaluation (PSE)) and 4 negative (appearance concerns (AC), body change concerns (BCC), life interference (LI) and worry (W)) impact dimensions [13] corresponding to the first 37 items.
The questionnaire also includes 10 additional items constituting conditional dimensions applicable to subsets of survivors assessing employment concerns (EC), relationship concerns for individuals with a partner (P), and relationship concerns for those without a partner (NP).
All items are scored on a five-point scale from 1 = strongly disagree to 5 = strongly agree.
A higher score on a dimension implies stronger endorsement of that content area
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up to 26 weeks
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The Quality of Life Patient/Cancer Survivor Version
大体时间：up to 26 weeks
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ordinal questionnaire measuring the quality of life in cancer patients over 42 items rated on 10 point Likert-type scale.
The revised instrument included 41 items representing the four domains of quality of life incorporating physical, psychological, social, and spiritual well being.
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up to 26 weeks
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Patient Health Questionnaire
大体时间：up to 26 weeks
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Subjects indicated for each of the nine depressive symptoms (corresponding to the criteria ofDSM-IV) whether, during the previous 2 weeks, the symptom has bothered them: 0=not at all; 1=several days; 2=more than half of the days; 3=nearly every day.
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up to 26 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年2月25日
初级完成 (预期的)
2021年12月1日
研究完成 (预期的)
2021年12月31日
研究注册日期
首次提交
2020年5月26日
首先提交符合 QC 标准的
2020年5月29日
首次发布 (实际的)
2020年6月4日
研究记录更新
最后更新发布 (实际的)
2021年8月25日
上次提交的符合 QC 标准的更新
2021年8月24日
最后验证
2021年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的