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Completed

NCT Number: NCT04083300

Cancer, Physical Activity and Quality of Life- a Longterm Follow up

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2021

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

    Time frame: 2022

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

    Time frame: 2023

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

    Time frame: 2024

Secondary outcomes

  1. Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study

    Time frame: 2021

    Experiences of the follow up.

Other outcomes

  1. The participants ability to work during the 5-years follow-up, using official register data and questionnaires.

    Time frame: 2020

    How many patients have been receiving sickness benefits, full or partial, or have returned to work. What characterizes the participants that fell out of working life after the cancer disease, concerning factors such as quality of life and social inequality measured by The Hospital Anxiety and Depression Scale (A 14-item questionnaire, where >8 indicate clinically significant level of anxiety/depression).

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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