Cancer Clinical Trial
Official title:
6-8 Years Follow up of Cancer Survivors, Objectively Measured Physical Activity and Quality of Life Over Time.
NCT number | NCT04083300 |
Other study ID # | 2018/1788 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 3, 2019 |
Est. completion date | January 30, 2020 |
Verified date | January 2020 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
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 |
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