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临床试验/NCT04083300
NCT04083300已完成不适用

6-8 Years Follow up of Cancer Survivors, Objectively Measured Physical Activity and Quality of Life Over Time.

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 271 人开始时间: 2019年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
271
试验地点
1
主要终点
Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study.

研究概览

简要总结

This project is a 6-8-years follow-up of a randomized controlled trial testing a stepped care stress management program. The main goal is to examining differences in long-term effects on cancer-related stress reactions and emotional reactivity between the intervention and control group. Secondary objectives is to investigate consequences of cancer and its' treatment over time, such as long term quality of life, objectively physical activity and experiences concerning follow-up and the transition from specialist health services to municipal health services.

详细描述

Major improvements in cancer detection and treatment lead to longer life expectancy among cancer survivors. This may in turn lead to more late effects and many have to deal with long-term consequences of the disease and its' treatment. Returning to everyday life and to work is often an important part of returning to normal life for cancer survivors. There is increasing knowledge concerning late effects, but there is still lack of knowledge concerning the life of those experiencing late effects. There is a need for more knowledge about late effects' impact on the return to work prosess, physical activity and quality of life over time. Both quantitative and qualitative methods will be utilized. Standardized questionnaires will provide information on the effect of the intervention over time, in addition to quality of life over time. Sensewear armband will provide information about their physical activity over time. Official register data from the Norwegian Labour and Welfare Administration (the NAV administration) will provide us information about the work- and benefit situation through the whole follow-up period of 6-8 years. The register data include information about type of social benefits (sick-leave benefit, work assessment allowance (WAA), disability pension, unemployment benefit and retirement pension), as well as information about occupation, income and sick leave diagnosis. Focus group interviews will give us insight in the cancer survivors own experiences with quality of life over time, the transition from the specialist health services to the primary health care and the follow-up in the municipalities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Stage I-III disease
  • •Scheduled for neo/adjuvant or curative treatment (i.e. chemotherapy, radiation therapy or hormonal therapy or any combination of these therapies)

排除标准

  • •On-going psychiatric condition
  • •Lack of fluency in Norwegian
  • •A previous diagnosis of cancer

结局指标

主要结局

Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study.

时间窗: 2021

Objectively measured physical activity from diagnosis to 6-8 years follow up.

时间窗: 2022

The context between change in physical activity and quality of life over time

时间窗: 2023

Witch predictors has an impact on long term cancer survivors quality of life?

时间窗: 2024

次要结局

  • Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study(2021)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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