跳至主要内容
临床试验/NCT02939612
NCT02939612进行中(未招募)不适用

Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: a Randomized Controlled Trial

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
The Perceived Stress Scale (PSS-14)

研究概览

简要总结

The purpose with this study is to test the effect of an app for stress management among patients with a variety of cancer diagnoses.

详细描述

A cancer diagnosis and subsequent treatment can be disruptive and traumatic, often accompanied by a multitude of stressors for the patients and their support network. Uncertainty of outcome and invasive medical procedures with aversive side effects are not uncommon, and while people differ widely in how they experience and cope with such challenges, cancer related distress including anxiety, depression, worry and rumination is prevalent. With multiple domains of function impacted it is also not surprising that quality of life (QoL) often is diminished.

Stress management interventions can facilitate adjustment to cancer, including reduced distress and improved quality of life. Unfortunately, many people with cancer do not have the strength or opportunity to attend groups or in-person interventions.

This study will therefore test the effect of an app for stress management among patients with different cancer diagnosis. The app contains 10 modules distributed over five weeks, focusing on education of different techniques for reduction of stress and stress reduction exercises.

The app was tested in a feasibility pilot study among 25 patients with a variety of cancer diagnoses and is now being tested in a randomized controlled trial with a sample of 175 cancer survivors. The participants were randomly assigned to use the 10 module app or to a control group that receive treatment as usual, and will be followed with repeated measures over 12 months.

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
All
接受健康志愿者

入选标准

  • Patients diagnosed with cancer (all diagnosis).
  • Maximum time since completed treatment at hospital: 12 months
  • Patients are > 18 years of age, able to write/read/speak Norwegian and have their own smart phone or tablet

排除标准

  • 未提供

结局指标

主要结局

The Perceived Stress Scale (PSS-14)

时间窗: Baseline, post intervention follow up at 3, 6, and 12 months

14 item scale measuring perceived stress. Scale range: 0-56. Higher scores indicate higher perceived stress.

次要结局

  • SF-36 Item Short Form Health Survey (RAND-36 version)(Baseline, post intervention follow up at 3, 6, and 12 months)
  • The Brief Coping Orientation to Problems (Brief COPE)(Baseline)
  • The Distress Thermometer(Baseline, post intervention follow up at 3, 6, and 12 months)
  • Health, well-being and sleep(Baseline, post intervention follow up at 3, 6, and 12 months)
  • The Self-Regulatory Fatigue-18 (SRF-18)(Baseline, post intervention follow up at 3 and 12 months)
  • The Hospital Anxiety and Depression Scale (HADS)(Baseline, post intervention follow up at 3, 6, and 12 months)
  • Intervention commentary(Post intervention (immediately post intervention))

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lise Solberg Nes

Head of Department

Oslo University Hospital

研究点 (1)

Loading locations...

相似试验