Longtime- Effects of an Early Rehabilitation Intervention for Cancer Patients
|ClinicalTrials.gov Identifier: NCT04083300|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : February 12, 2020
|Condition or disease|
|Cancer Rehabilitation Stress Disorder Fatigue|
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 therapy. Returning to work is often an important part of returning to normal life for patients in working age. Many cancer survivors have trouble with participation in working life, and cancer is a significant cause of absence from work, unemployment and early retirement. There is increasing knowledge around late effects, but there is still lack of knowledge concerning the life of those experiencing late effects. There is a need for more knowledge concerning late effects impact on work participation over time, and how employers and the social security offices (NAV) can facilitate for work participation in a better way. 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 five 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 participants own experiences with the transition from the specialist health services to the primary health care and the follow-up in the municipalities, from employers and NAV, and information about their presence and efficiency at the workplace.
Both quantitative and qualitative methods will be utilized to answer our research questions. Standardized questionnaires will be employed to investigate the relationship between the participants' health situation, quality of life and level of physical activity. The questionnaires contain questions about stress, subjective health complaints, diseases, anxiety, depression, fatigue, physical activity, education, income and work ability.
|Study Type :||Observational|
|Estimated Enrollment :||271 participants|
|Official Title:||Longtime- Effects of an Early Rehabilitation Intervention for Cancer Patients, a Five-year Follow-up of a Randomized Controlled Trial Testing a Stepped Care Stress Management Program|
|Actual Study Start Date :||January 3, 2019|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||June 30, 2021|
- Cancer-related stress reactions more than five years after the diagnosis and inclusion in the study. [ Time Frame: 2019 ]Long term effect of the intervention measured by The Impact of Event Scale (A 15-item questionnaire. Cut-off scores to indicate cases of low (=8), medium (9-19) and high (>20) levels of cancer-related stress reactions. > 9 is the cut-off score chosen for the present study to indicate clinically significant levels).
- Collect knowledge concerning the participants experiences of the transition from the specialist health services to the primary health care, the follow-up in the municipalities, from their employer and NAV, throgh focus group interview. [ Time Frame: 2020 ]Experiences of the follow up.
- The participants ability to work during the 5-years follow-up, using official register data and questionnaires. [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083300
|Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital|
|Bergen, Norway, 5021|