Trial document




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  DRKS00005066

Trial Description

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Title

Intervention oriented to occupation for oncological patients: Concept and Evaluation of the intervention "perspective job" in the oncological rehabilitation

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Trial Acronym

BIOR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Due to the insufficient data situation concerning effective Work Related Medical Rehabilitation (MBOR) in the oncological rehabilitation an occupation-oriented module (intervention „perspective job“) should be conceived with the rehabilitation team, be implemented in the process of a stationary, oncological rehabilitation and be evaluated. The intervention „perspective job“ is checked on one hand within a process evaluation to be able to value the conversion, the contents, course, target group specificity as well as the acceptance comprehensively. On the other hand, the first data should be raised about the effectiveness of the intervention “perspective job” (outcome evaluation). This is based on a prospective intervention control group design. Study participants are oncological patients.
While the control group receives the clinic program (usual care), the intervention group takes additionally part in the intervention „perspective job“. The study participants were interviewed with a questionnaire at the beginning, at the end, three and six months after the rehabilitation. The participants received one and four months after discharge an interview via telephone (control group) or a telephone based aftercare (intervention group).
Main questions are: Is there a difference between the intervention group and control group up to six months after discharge from the rehabilitation concerning (a) the functional capability in occupational, (b) in the coping with working and occupational standards and (c) in the subjective prognosis of gainful employment.
At the end a manual of the intervention „perspective job“ is available including the representation of structured paths of treatment.

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Brief Summary in Scientific Language

Within the scope of the BIOR-study the occupation-oriented module (intervention „perspective job“) should be conceived with the rehabilitation team, be implemented in the process of a stationary, oncological rehabilitation and be evaluated.
Sequential study design: First the control group is recruited. The Intervention “Perspective Job” will be implemented into the clinic after the discharge of all patients of the control group. Than the intervention group is recruited.
Main questions are: Is there a difference between the intervention group and control group up to six months after discharge from the rehabilitation concerning (a) the functional capability in occupational, (b) in the coping with working and occupational standards and (c) in the subjective prognosis of gainful employment.

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Organizational Data

  •   DRKS00005066
  •   2013/06/27
  •   [---]*
  •   yes
  •   Approved
  •   2012-455-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C81-C96 -  Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
  •   C51-C58 -  Malignant neoplasms of female genital organs
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Interventions/Observational Groups

  •   Control group: The study participants receive the clinic program (usual care). The participants receive one and four months after discharge an interview via telephone, asked for their health and occupational situation.
  •   Intervention group: The study participants receive the clinic program (usual care) and take additionally part in the intervention „perspective job“.They receive one and four months after discharge a telephone based aftercare.

    The development of the final intervention “Perspective Job” occurs in the rehab-team. The intervention will be consists of the components probably: three seminars, two counseling interviews during the clinical setting, one team-round and a telephone based aftercare (see above).
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Measuring time 3 and 6 months after discharge
The functional capability in occupational (measuring instrument IRES-3; Bührlen et al. 2005)

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Secondary Outcome

Measuring time 3 and 6 months after discharge
Occupational stress and coping inventory (measuring instrument: AVEM; Schaarschmidt & Fischer, 2006)
Subjective prognosis for gainful employment (measuring instrument: SPE-Scale; Mittag & Raspe, 2003)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/07/01
  •   210
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   62   Years
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Additional Inclusion Criteria

Oncological patients,
see below Exclusion Criteria

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Exclusion Criteria

(1) Advanced tumor / palliative situation, (2) insufficient German knowledge, (3) patient is retired (old-age pension / unlimited EU pension), (4) patient is older than 62 years

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Addresses

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    • Verein zur Förderung der Rehabilitationsforschung e.V., Norderney
    • Kaiserstraße 26
    • 26548  Norderney
    • Germany
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    • Institut für Rehabilitationsforschung, Norderney: Abteilung Bad Salzuflen
    • Ms.  Dr.  Heike  Kähnert 
    • Alter Vlothoerstraße 1
    • 32105  Bad Salzuflen
    • Germany
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    • Institut für Rehabilitationsforschung, Norderney: Abteilung Bad Salzuflen
    • Ms.  Dr.  Heike  Kähnert 
    • Alter Vlothoerstraße 1
    • 32105  Bad Salzuflen
    • Germany
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Sources of Monetary or Material Support

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    • Verein zur Förderung der Rehabilitationsforschung e.V., Norderney
    • Kaiserstraße 26
    • 26548  Norderney
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.