Trial document





This trial has been registered retrospectively.
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  DRKS00004836

Trial Description

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Title

Evaluation of coping with oral cancer and oral premalignant lesions

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Trial Acronym

Coping with oral cancer

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URL of the Trial

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Brief Summary in Lay Language

Patients with squamous cell carcinoma are examined with regard to their coping processes, and the factors that influence it, and compared with a control group consisting of patients with oral premalignant lesions. The aim of the study is to investigate the influence of different factors, such as the locus of control, social support or religiosity, on the coping processes of the patient.

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Brief Summary in Scientific Language

Background
The prognosis for patients with oral squamous cell carcinoma (OSCC) remains poor despite advances in treatment concepts. Not only early diagnosis and treatment are important to improve patient’s survival but also psychological well-being. In light of the high prevalence of OSCC and the associated negative consequences for rehabilitation an optimal support of these patients in coping with their illness is of great importance. In order to be able to offer such a support, it is necessary to analyse the complex coping mechanisms of these patients.
Method
Design: A controlled longitudinal prospective trial. Participants: 400 patients diagnosed with OSCC will be recruited from the Hannover Medical School, Department of Craniomaxillofacial Surgery. A control group of 120 patients will exist of patients with oral premalignant lesions. Intervention: Validated questionnaires measuring coping, its influence factors (sociodemographic variables, social support, locus of control, religiosity, personality, optimism, anger expression, hope, hopelessness) and outcomes (quality of life, symptomseverity) will be given to both groups. After two weeks, six months and one year, they will be asked on their quality of life and symptom severity again. Outcomes: The correlations between the constructs will be analyzed using multiple regression analyzes. After six months the differences regarding coping mechanisms between patients with high and low quality of life and symptom severity will be investigated and compared with the results of the control group.

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Organizational Data

  •   DRKS00004836
  •   2013/03/26
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  •   yes
  •   Approved
  •   5586/2013, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   C44 -  Other malignant neoplasms of skin
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Interventions/Observational Groups

  •   For the first time of the survey patients with squamous cell carcinoma are assessed with the following questionnaires: FPI-R, F-SozU, SpREUK-P, FKK, LOT-R, STAXI.

    For the second time of the survey after 2 weeks they are asked again with thequestionnaires UW-QOL v4, WOC-CA, BSCL-53, HHIndex, H-Skalen and LOT-R.

    For the third time (after 6 moths) and fourth time (after one year) of the survey, they are asked again with thequestionnaires WOC-CA, BSCL-53, UW-QOL4, Brief COPE and LOT-R.
  •   For the first time of the survey patients with oral premalignant lesions are assessed with the following questionnaires: FQCI SA, F-SozU, KKG, SBI-15-RD, FPI-R, UW-QOL v4, BSI
    For the second time of the survey after 6 months they are asked again with the two questionnaires UW-QOL v4 and BSI.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

For the first time of the survey, personality (FPI-R), locus of control (FKK), religiosity (SpREUK-P), social support (F-SozU), anger expression (STAXI) and optimism (LOT-R) will be obtained and the relationships between these variables will be determined.

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Secondary Outcome

For the second time of the survey after 2 weeks, third time after 6 months and fourth time of the survey after one year, patients are again asked about their quality of life and symptomseverity in order to analyze the factors which influence the level of quality of life and symptomseverity.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/01
  •   400
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

-OSCC
-Oral premalignant lesion (leukoplakia, erythroplakia, lichen planus or pemphigus vulgaris)
-Written informed consent

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Exclusion Criteria

-Tumor recurrences
-missing operability
-foreseeable missing opportunity of follow-up examination
-pregnancy, heart-, pulmonal-, liver- and kidney disease, chronic pain syndrom
-nursing, drug addiction, recent operations, and diseases like heart, metabolism, CNS, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics
-Dermatological diseases of the face

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Addresses

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    • Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Majeed  Rana 
    • 30625   Hannover
    • Germany
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    • Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Alexander  Gröbe 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.   Majeed   Rana 
    • Carl-Neuberg-Str. 1
    • 30625   Hannover
    • Germany
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    • Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Majeed  Rana 
    • Carl-Neuberg-Str. 1
    • 30625   Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Mr.  Dr. Dr.  Majeed  Rana 
    • Carl-Neuberg-Str. 1
    • 30625   Hannover
    • Germany
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Status

  •   Recruiting ongoing
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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.