Trial document



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  DRKS00013493

Trial Description

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Title

Pilot study on the feasibility and efficacy of individual psychooncological intervention to better cope with therapy-related stress in oncological patients under radiotherapy ("With internal strength through radiation therapy")

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Trial Acronym

MISS

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URL of the Trial

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Brief Summary in Lay Language

Radiation therapy represents a particular burden on patients and impairs their quality of life. When patients have to cope with the challenges of cancer and its treatment,
they may find it helpful to have special techniques at disposal that can help to better cope with difficult Situation.
Our psychooncology service MISS is especially aimed at people with head/neck tumours, in which radiation treatment is planned or who are already undergoing radiation therapy.
Within the framework of the study, imagination exercises are practiced in an average of three individual sessions.
The quality assurance is carried out by checking the success of therapy with scientific methods.

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Brief Summary in Scientific Language

Patients with malignant tumours in the head and/or neck area suffer from particularly severe impairments of the quality of life and psychological well-being compared to other malignant diseases. Radiation therapy is carried out under particularly stressful conditions. The patients receive a custom-fit plastic mask for the face and are fixed up to 5x/week for up to 20 minutes during radiation for several weeks. A considerable number of patients suffer from anxiety and panic attacks. The psychoimaginative trauma therapy works with psychotherapeutic (relaxation) techniques, which can be learned easily and used successfully in trauma therapy as well as in breast cancer patients for self-control and stress management. The aim of the planned feasibility study (in preparation of a study programme to check the effectiveness) is to verify the feasibility of an individual psychooncological intervention (imagination) to better cope with therapy related stress in oncological patients under radiotherapy. The target group includes in particular patients whose tumor is located in the head and neck area and whose plastic mask has to be created or fixed for radiotherapy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013493
  •   2017/11/27
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  •   yes
  •   Approved
  •   S-537/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C32 -  Malignant neoplasm of larynx
  •   Head/neck tumours
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Interventions/Observational Groups

  •   Imagination exercises are practiced in an average of three individually agreed individual sessions. The appointments take place weekly to 14 days.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

(1) the feasibility of sufficient patient recruitment
(2) the termination rate
(3) the response rate to the questionnaire survey

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Secondary Outcome

- distress (anxiety, depression, distress, disease-related trauma symptoms): corresponding scales of the German version of the Patient Health Questionnaire, Distress-Barometer (PHQ-D; Lowe, Spitzer, Zipfel, & Herzog, 2002), Posttraumatic Diagnostic Scale (PDS; German translation of Ehlers, Steil, Winter, & Foa,,)
- Self-soothing ability: Subscale "Self-soothing ability" of the self-soothing scale (Beck et al., in preparation).
- Quality-of-life: Short version of the questionnaire on general state of health (SF-12; Bullinger & Kirchberger, 1998; Gandek et al., 1998).

All questionnaires used in this preliminary study are validated routine instruments.

The questionnaires are assessed at the first session of the Intervention (T1) and at the end of radiation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/12/01
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

(1) Oncological patients fixed for radiotherapy
(2) oncological patients with a tumor in the head area who receive plastic masks for radiotherapy
(3) planned or already initiated radiotherapy
(4) Interest in learning and applying stabilisation exercises
(5) Notification of informed written consent to study participation

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Exclusion Criteria

(1) Age < 18 years
(2) acute suicidal tendencies
(3) the existence of contraindications for imaginative procedures: schizophrenic psychoses, dissociative disorders
(4) Insufficient understanding of the German language
(5) severe hearing loss
(6) lack of ability to give consent

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Addresses

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    • Universitätsklinikum HeidelbergAbteilung Innere Medizin und Psychosomatik
    • Mr.  Prof.  Wolfgang  Herzog 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Mr.  Dr.  Imad  Maatouk 
    • Im Neuenheimerfeld 410
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Mr.  Dr. med.  Sebastian  Adeberg 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Ms.  Dr.  Christina  Sauer 
    • Im Neuenheimerfeld 410
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Ms.  Dr.  Christina  Sauer 
    • Im Neienheimerfeld 410
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum HeidelbergAbteilung Innere Medizin und Psychosomatik
    • Mr.  Prof.  Wolfgang  Herzog 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/31
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Trial Publications, Results and other Documents

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