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)

Not Applicable

• Conditions: Head/neck tumours; C32; Malignant neoplasm of larynx

• Registration Number: DRKS00013493
• Lead Sponsor: niversitätsklinikum HeidelbergAbteilung Innere Medizin und Psychosomatik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-27
• Study Completion: 2019-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) the feasibility of sufficient patient recruitment<br>(2) the termination rate<br>(3) the response rate to the questionnaire survey<br>

Secondary Outcome Measures

Name	Time	Method
- 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,,)<br>- Self-soothing ability: Subscale Self-soothing ability of the self-soothing scale (Beck et al., in preparation).<br>- Quality-of-life: Short version of the questionnaire on general state of health (SF-12; Bullinger & Kirchberger, 1998; Gandek et al., 1998). <br><br>All questionnaires used in this preliminary study are validated routine instruments.<br><br>The questionnaires are assessed at the first session of the Intervention (T1) and at the end of radiation.