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Imfinzi NSCLC
Imfinzi NSCLC

JOURNAL ONKOLOGIE – STUDIE

OptiScreen Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm

Rekrutierend

NCT-Nummer:
NCT04638699

Studienbeginn:
April 2020

Letztes Update:
23.11.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Hannover Medical School

Collaborator:
Universitätsklinikum Leipzig, UniversitätsKrebsCentrum Dresden,

Studienleiter

Tanja Zimmermann
Principal Investigator
Hannover Medical School

Kontakt

Tanja Zimmermann, Prof.
Kontakt:
Phone: +49511532
Phone (ext.): 3133
E-Mail: zimmermann.tanja@mh-hannover.de
» Kontaktdaten anzeigen

Studienlocations (1 von 1)

Studien-Informationen

Detailed Description:

Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer

patients and their families and to improving the quality of life of all those affected. In

order to ensure patient-oriented psycho-oncological care, it is necessary to allocate

psychologically burdened patients and patients in need of care to psycho-oncology by means of

screening.

Within the framework of this multicenter study (Hannover, Leipzig and Dresden), a newly

designed training of nursing staff ("OptiScreen training") on mental stress and

psycho-oncological care is intended to increase the precise identification of mentally

stressed patients in need of treatment, to increase the allocation of these patients to

psycho-oncology and to improve interdisciplinary cooperation.

Aims of the study:

1. targeted, needs-based allocation to psycho-oncology

2. increasing the acceptance of psycho-oncological screening by patients* and treatment

team

3. increase of patient competence and satisfaction

4. increasing the acceptance of psycho-oncological treatment by patients and treatment team

In summary, the findings of this multi-center study should contribute to the improvement

of interdisciplinary cooperation, improve the demand-oriented and targeted allocation of

psychologically burdened patients to psycho-oncological care and thus develop a "best

practice model" of an interdisciplinary care algorithm.

Methodology

The study will include inpatients from the visceral oncology centers at the three sites who

have the necessary cognitive, physical and linguistic abilities. The study is divided into 2

phases:

Phase 1: Survey of the current status For this purpose, N = 300 patients* in the visceral

oncology centers are interviewed with a questionnaire during the inpatient stay (t0) and

three months later (t1).

The data collected will include psychological stress, disease management/treatment, quality

of life and treatment satisfaction of persons with oncological diseases. In addition, the

needs for information and support, the practicability as well as the allocation to

psycho-oncological care and its utilization will be surveyed.

Execution of the "OptiScreen training": special psycho-oncological training of the nursing

staff for basic knowledge about the experience of psychological stress as well as diagnostics

of psychosocial stress will take place after the completion of phase 1.

Phase 2: survey after the OptiScreen training Analogous to phase 1, N = 600 patients* in the

visceral oncology centers are interviewed during the inpatient stay (t0) and three months

later (t1).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- In-patients of the visceral oncology centers at the three locations

Exclusion Criteria:

- severe physical, cognitive and/or language limitations

Studien-Rationale

Primary outcome:

1. Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Distress Thermometer (NCCN Distress Thermometer)



Secondary outcome:

1. Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Patient Health Questionnaire (PHQ-9)

2. Frequency and extent of anxiety in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Generalized Anxiety Disorder 7 (GAD-7)

3. Frequency and extent of supportive care needs in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Supportive Care Needs Survey Short Form German (SCNS-SF34-G)

4. Frequency and extent of fear of cancer recurrence in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Progredienangstfragebogen (PA-F; Fear of Progression Questionnaire)

5. Frequency and changes in quality of life in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Short Form-8 Health Survey SF-8

6. Frequency and extent of relationship satisfaction in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Quality of Marriage Index (QMI)

7. Satisfaction with medical and psychosocial treatment in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
REPERES-G: Assessment of care

8. Frequency and extent of health competence (Access to information, understanding, evaluating and applying of information) in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
European Health Literacy Questionnaire

9. Frequency and extent of self-management and active patient participation in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Patient Activation Measure (PAM 13D; German version of the Patient Measure

10. Frequency and extent of satisfaction with body image in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Body-Image-Scale

11. Frequency and extent of social support in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Scales for social support during illness (SSUK Skalen zur sozialen Unterstützung bei Krankheit) zur sozialen Unterstützung bei Krankheit-8 (SSUK-8; llness-specific Social Support Scale)

12. Frequency and extent of resources (Health promoting activities, active participation, emotional stress, self-monitoring etc.in cancer patients (CG vs. IG) and changes over time (Time Frame - T0 (at hospital stay) and T1 (3 months later)):
Health Education Impact Questionnaire

Studien-Arme

  • No Intervention: Phase 1 Survey of the actual state
  • Other: Phase 2 Survey after the OptiScreen training

Geprüfte Regime

  • OptiScreen training:
    Special psycho-oncological training for nursing staff to acquire basic knowledge about the experience of mental stress as well as diagnostics of psychosocial stress

Quelle: ClinicalTrials.gov


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