Clinical trial NCT04083300: Cancer, Physical Activity and Quality of Life- a Longterm Follow up
Official title: 6-8 Years Follow up of Cancer Survivors, Objectively Measured Physical Activity and Quality of Life Over Time.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Rehabilitation
Stress Disorder
Fatigue
Quality of Life
Physical Activity
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer survivors who participated in the early "Early rehabilitation of cancer patients" (ClinicalTrials.gov Identifier: NCT 01588262) were asked to join this follow up study.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study.
timeFrame: 2021
measure: Objectively measured physical activity from diagnosis to 6-8 years follow up.
timeFrame: 2022
measure: The context between change in physical activity and quality of life over time
timeFrame: 2023
measure: Witch predictors has an impact on long term cancer survivors quality of life?
timeFrame: 2024
Secondary outcomes:
measure: Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study
timeFrame: 2021
Other outcomes:
measure: The participants ability to work during the 5-years follow-up, using official register data and questionnaires.
timeFrame: 2020
Locations:
city: Bergen
country: Norway
facility: Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital
Study officials:
References: