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Longtime- Effects of an Early Rehabilitation Intervention for Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083300
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Brief Summary:
This project is a five-year 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. In addition, we want to investigate cancer patients experiences concerning follow-up and the transition from specialist health services to municipal health services. The consequences of cancer and its treatment over time, and the participants' own experiences with living an active and social life after cancer, e.g. related to physical activity and working life will also be investigated.

Condition or disease
Cancer Rehabilitation Stress Disorder Fatigue

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 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.

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Study Type : Observational
Estimated Enrollment : 271 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cancer survivors who participated in the early rehabilitation program in 2011: The Norwegian randomized controlled trial "Early rehabilitation of cancer patients" (ClinicalTrials.gov Identifier: NCT 01588262) are includede in this follow up study. 256 is still alive and asked to join this follow up study, both the intervention group and the control group.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083300


Locations
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Norway
Department of Oncology and Medical Physics, Cancer center for Education and rehabilitation, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04083300    
Other Study ID Numbers: 2018/1788
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms