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

Sponsor
Haukeland University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04083300
Collaborator
(none)
271
1
12.9
21

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    271 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    6-8 Years Follow up of Cancer Survivors, Objectively Measured Physical Activity and Quality of Life Over Time.
    Actual Study Start Date :
    Jan 3, 2019
    Actual Primary Completion Date :
    Jan 30, 2020
    Actual Study Completion Date :
    Jan 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study. [2021]

    2. Objectively measured physical activity from diagnosis to 6-8 years follow up. [2022]

    3. The context between change in physical activity and quality of life over time [2023]

    4. Witch predictors has an impact on long term cancer survivors quality of life? [2024]

    Secondary Outcome Measures

    1. Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study [2021]

      Experiences of the follow up.

    Other Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital Bergen Norway 5021

    Sponsors and Collaborators

    • Haukeland University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haukeland University Hospital
    ClinicalTrials.gov Identifier:
    NCT04083300
    Other Study ID Numbers:
    • 2018/1788
    First Posted:
    Sep 10, 2019
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 10, 2021