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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083300
• Other study ID #: 2018/1788
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: January 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Fatigue
• Physical Activity
• Quality of Life
• Rehabilitation
• Stress Disorder

Locations

Country	Name	City	State
Norway	Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The participants ability to work during the 5-years follow-up, using official register data and questionnaires.	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).	2020
Primary	Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study.		2021
Primary	Objectively measured physical activity from diagnosis to 6-8 years follow up.		2022
Primary	The context between change in physical activity and quality of life over time		2023
Primary	Witch predictors has an impact on long term cancer survivors quality of life?		2024
Secondary	Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study	Experiences of the follow up.	2021