Clinical trial NCT04638699: Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm
Official title: Optimized Psycho-oncological Care Through an Interdisciplinary Care Algorithm: From Screening to Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psycho-Oncology
Visceral Cancer
Screening
Psychosocial Stressor
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
name: UniversitätsKrebsCentrum Dresden
First posted: 2020-11-20
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* severe physical, cognitive and/or language limitations

Primary outcomes:
measure: Frequency of Psychological distress in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
Secondary outcomes:
measure: Frequency and extent of depression in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and extent of anxiety in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and extent of supportive care needs in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and extent of fear of cancer recurrence in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and changes in quality of life in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and extent of relationship satisfaction in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Satisfaction with medical and psychosocial treatment in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: 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
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and extent of self-management and active patient participation in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and extent of satisfaction with body image in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: Frequency and extent of social support in cancer patients (CG vs. IG) and changes over time
timeFrame: T0 (at hospital stay) and T1 (3 months later)
measure: 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
timeFrame: T0 (at hospital stay) and T1 (3 months later)
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Tanja Zimmermann
role: PRINCIPAL_INVESTIGATOR
References: