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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cancer; Fatigue; Physical Activity; Rehabilitation; Stress Disorder

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 Type: Observational
• Enrollment (Actual): 271

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cancer-related stress reactions 6-8 years after the diagnosis and inclusion in the study.	2021
Objectively measured physical activity from diagnosis to 6-8 years follow up.	2022
The context between change in physical activity and quality of life over time	2023
Witch predictors has an impact on long term cancer survivors quality of life?	2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer survivors' experience of quality of life 6-8 years after diagnosis- a qualitative study	Experiences of the follow up.	2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2018/1788

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No