Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm

Screening Clinical Trial

— OptiScreen  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638699
• Other study ID #: 70113550
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Hannover Medical School
• Contact: Tanja Zimmermann, Prof.
• Phone: +49511532
• Email: zimmermann.tanja[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• severe physical, cognitive and/or language limitations

Related Conditions & MeSH terms

• Neoplasms
• Psycho-Oncology
• Psychosocial Stressor
• Screening
• Visceral Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hanover

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	Universitätsklinikum Leipzig, UniversitätsKrebsCentrum Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time	Distress Thermometer (NCCN Distress Thermometer)	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time	Patient Health Questionnaire (PHQ-9)	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of anxiety in cancer patients (CG vs. IG) and changes over time	Generalized Anxiety Disorder 7 (GAD-7)	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of supportive care needs in cancer patients (CG vs. IG) and changes over time	Supportive Care Needs Survey Short Form German (SCNS-SF34-G)	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of fear of cancer recurrence in cancer patients (CG vs. IG) and changes over time	Progredienangstfragebogen (PA-F; Fear of Progression Questionnaire)	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and changes in quality of life in cancer patients (CG vs. IG) and changes over time	Short Form-8 Health Survey SF-8	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of relationship satisfaction in cancer patients (CG vs. IG) and changes over time	Quality of Marriage Index (QMI)	T0 (at hospital stay) and T1 (3 months later)
Secondary	Satisfaction with medical and psychosocial treatment in cancer patients (CG vs. IG) and changes over time	REPERES-G: Assessment of care	T0 (at hospital stay) and T1 (3 months later)
Secondary	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	European Health Literacy Questionnaire	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of self-management and active patient participation in cancer patients (CG vs. IG) and changes over time	Patient Activation Measure (PAM 13D; German version of the Patient Measure	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of satisfaction with body image in cancer patients (CG vs. IG) and changes over time	Body-Image-Scale	T0 (at hospital stay) and T1 (3 months later)
Secondary	Frequency and extent of social support in cancer patients (CG vs. IG) and changes over time	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)	T0 (at hospital stay) and T1 (3 months later)
Secondary	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	Health Education Impact Questionnaire	T0 (at hospital stay) and T1 (3 months later)