Skip to main content
Clinical Trials/NCT04638699
NCT04638699
Recruiting
Not Applicable

Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm: From Screening to Intervention

Hannover Medical School1 site in 1 country900 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psycho-Oncology
Sponsor
Hannover Medical School
Enrollment
900
Locations
1
Primary Endpoint
Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Adequate, needs-oriented psycho-oncological care contributes to reducing the burden on cancer patients and their relatives and to improving the quality of life. There is still a need for clarification regarding the need and the determination of psychosocial needs. This multi-center study (3 centers: Hanover, Leipzig and Dresden) aims at a professionalization of psychosocial screening, in order to enable thus an exact and need-based allocation to psycho-oncological support. The optimization and professionalization of the psychosocial screening process shall be achieved by a training of oncological nursing and development of an interdisciplinary care algorithm. The aim is to examine whether "OptiScreen" increases the targeted and needs-based allocation to psycho-oncology.

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).

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zimmermann, Tanja Prof. Dr.

Prof. Dr. Tanja Zimmermann

Hannover Medical School

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • severe physical, cognitive and/or language limitations

Outcomes

Primary Outcomes

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 Outcomes

  • Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and extent of satisfaction with body image in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and extent of anxiety in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and extent of supportive care needs in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and extent of relationship satisfaction in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • 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(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and extent of fear of cancer recurrence in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and extent of social support in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and changes in quality of life in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Satisfaction with medical and psychosocial treatment in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • Frequency and extent of self-management and active patient participation in cancer patients (CG vs. IG) and changes over time(T0 (at hospital stay) and T1 (3 months later))
  • 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(T0 (at hospital stay) and T1 (3 months later))

Study Sites (1)

Loading locations...

Similar Trials